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legislative session, the ongoing policy wars against abortion and the facilities that provide them are already heating up in several states across the country

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ACROSS AMERICA — Only a handful of weeks into the 2021 legislative session, the ongoing policy wars against abortion and the facilities that provide them are already heating up in several states across the country.

It’s been nearly a half-century since the U.S. Supreme Court handed down its landmark ruling in the case of Roe v. Wade, which granted women a constitutional right to obtain an abortion. Yet in the decades since that ruling, states have spent significant time battling its provisions.

From 2011 to 2017, 32 U.S. states enacted a total of 394 restrictions, most of which regulate or limit when, under what circumstances, and even if a woman may obtain an abortion.

This year is shaping up to be no different.

Since the start of the 2021 legislative season in January, more than 140 anti-abortion bills have been introduced in statehouses across the country, according to Rachel Sussman, vice president of state policy and advocacy for Planned Parenthood Federation of America.

The end result: a tangled web of abortion policy that lawmakers continue to spin, and a significant reduction in women’s access to abortion services.

“Over the past decade, there has been a jolt towards harmful, politically motivated abortion restrictions from politicians across the country,” Sussman said.

Yet nearly a year into the coronavirus pandemic, many have lost more than just access to an abortion clinic.

They’ve lost a vital lifeline to a suite of medical services that prevent unwanted pregnancies, provide life-saving diagnoses and help stop the spread of communicable diseases.

Ultimately, much of the legislation has further pushed basic health care out of reach, especially for people with low incomes, and those living in rural or minority communities.
Lawmakers Battle A Declining Issue

The legislative push comes as the number of women receiving the procedure is declining.

Centers for Disease Control and Prevention data shows abortions declined 22 percent over a decade, to nearly 620,000 in 2018 — or 11.3 per every 1,000 women ages 15 to 44.

While it reflects slightly different data, a 2019 report by the Guttmacher Institute underscores the CDC’s findings. Report authors also took their research a step further, suggesting that legislation is not the key driver of the decline in abortions. Instead, they cited a broader decline in pregnancies, and said it was likely a result of increased access to birth control since the Affordable Care Act was enacted in 2011.

“What’s true is that increasing people’s access to affordable and effective methods of birth control leads to fewer abortions,” Sussman said.

Despite the decrease, abortion foes continue to target health care facilities that provide these services.

Between 2011 and 2017, the number of clinics providing abortion in the United States declined by about 4 percent, according to the Guttmacher Institute. The decrease seems low, yet some areas of the country were hit harder than others.

During the same period, the South saw a net decline of 50 clinics, with 25 in Texas alone. The Midwest lost 33 clinics, including nine each in Iowa, Michigan and Ohio. Seven clinics shuttered in Western states.

By contrast, Northeast states added 59 clinics, mostly in New Jersey and New York.

The South and the Midwest also had the largest share of new abortion restrictions during that period — nearly 86 percent of total enacted restrictions were in those two regions.

Today, five states — Mississippi, Missouri, North Dakota, South Dakota and West Virginia — have only one remaining abortion provider each.

Despite the election of Democratic President Joe Biden and Vice President Kamala Harris, 29 states currently have legislatures where anti-abortion politicians hold the majority, according to Sussman. Of the legislation introduced this session, 40 percent involves a form of abortion ban.

Kansas is an extreme example. There, voters will decide in 2022 whether the state’s constitution protects abortion rights under a ballot measure approved by the state Senate.

And in South Carolina, a bill that would ban abortion before most people even know they’re pregnant was fast-tracked through the state’s Legislature only to be blocked by a federal judge a day after it went into effect.

“Politicians are wasting no time attacking access to sexual and reproductive health care,” Sussman said. “Some are still doing everything they can to take control of our bodies, lives and futures.”
Who Stands To Lose Most

Perhaps the most notable provider of sexual health and reproductive services, Planned Parenthood has more than 49 affiliates that operate 600 health care centers across the nation. Annually, the organization provides sexual and reproductive health services to more than 2.4 million people, 39 percent of whom are people of color.

Of those, more than 541,000 patients identify as Latino and 395,000 as Black. More than 297,000 male patients also receive services. Finally, Planned Parenthood also provides gender-affirming hormone therapy for transgender patients in 31 states.

In 2018, of Planned Parenthood patients who reported their income, nearly 75 percent were living at or below 150 percent of the federal poverty level — the equivalent of $37,650 a year for a family of four.

“Patients don’t come to us to make a political statement,” Sussman of Planned Parenthood said. “They come to get compassionate, expert care and education.”

Still, Planned Parenthood has frequently been the target of both state and federal lawmakers.

In 2019, Planned Parenthood dropped out of a $260 million federal family planning program rather than comply with what it called a “gag rule” imposed by the Trump administration on abortion referrals.

The order would have prohibited health clinics from receiving federal funds under Title X if abortions were performed at the facility or if specialists referred patients to centers where they could get an abortion. The administration made the call despite the Hyde Amendment which, passed in 1976, prohibits federal funding from directly paying for abortions.

While some states stepped in to cover the lost funding, others did not.

In total, providers in 34 states were forced out of the program, according to Planned Parenthood, prompting more than 1.5 million people across the country to lose access to Title X-supported services such as affordable birth control and sexually transmitted infection testing.

According to the organization’s 2018-19 annual report, abortions comprised only 4 percent of Planned Parenthood’s provided services, while sexually transmitted infection testing and treatment comprised 50 percent, contraception made up 26 percent, and 13 percent was attributed to other women’s health services such as well-woman exams and prenatal care.

Many of those who lost access to these crucial services were likely women of color. According to a 2018 fact sheet by the National Latina Institute for Reproductive Health, women of color make up more than half, and Latinas more than a third, of all Title X patients.

“People don’t turn to politicians for advice about cancer screenings or STI treatment,” Sussman said. “The bottom line is that Planned Parenthood has been around for over 100 years, and we’re not going anywhere.”
Anti-Abortion Groups Keep Fighting

While Planned Parenthood is gearing up to challenge several pieces of 2021 legislation, anti-abortion groups are lauding the efforts already being made by lawmakers this session.

National Right to Life, a federation with 50 state affiliates and more than 3,000 local affiliates, was founded in 1968 with the goal of creating a national organization to deal with life issues on the federal level. The organization’s oldest affiliate, Virginia Society for Human Life, was founded in 1967.

While National Right For Life is most known for its stance against abortion, the organization also provides education and lobbies on legislation pertaining to other life issues such as infanticide, assisted suicide and euthanasia.

While the organization works at a national level, its affiliates provide support, testimony and other help to states regarding anti-abortion legislation.

National Right To Life is also looking ahead to 2021, and leaders are anticipating “significant challenges” at the federal level, according to spokesperson Laura Echevarria.

Among them is the possible certification of the 1972 Equal Rights Amendment to the U.S. Constitution. In January 2020, Virginia became the 38th state to ratify the amendment, which guarantees equal rights for women. The vote followed ratifications by Nevada in 2017 and Illinois in 2018 after four decades of inactivity.

Hurdles remain in the path of the amendment’s certification, however. The ratification deadlines that Congress set after it approved the amendment have lapsed, and five states have acted to rescind their prior approval.

The Equal Rights Amendment has come under fire by anti-abortion proponents, some of whom claim that it would require taxpayer-funded abortions. Since only women can have abortions, any restrictions on the procedure could be deemed unconstitutional under the amendment.

“Everyone knows this renewed effort isn’t about women’s rights,” the office of House Republican Whip Steve Scalise said in a February 2020 report by Politico, summarizing the message sent by the GOP caucus. “It’s about eliminating federal and state life protections and ushering in an era of taxpayer funding of abortion.”

While the certification of the amendment ultimately passed in the Democratic-controlled House of Representatives, it was dead on arrival in the Republican-controlled Senate.

Following the 2020 election, Democrats now hold a razor-thin majority in the Senate.

“We see the right to life as the leading human rights issue of our day,” Echevarria said. “Without abortion-neutralizing language, the Equal Rights Amendment would be used to expand abortion on demand. We’ve seen this happen in states that use the same language in state ERAs.”

When it comes to how anti-abortion legislation might affect access to free and low-cost health care, Echevarria said that National Right To Life typically doesn’t take a stance on health care issues unless it’s somehow related to taxpayer funding of abortion or health care plans that are forced to cover abortions.

If a woman is in need of such health care, Echevarria recommended she seek out one of more than 2,700 pregnancy centers across the United States that provide free services to women in need, most of which are manned primarily by volunteers and financially supported with private funds from individuals, religious organizations and businesses.

In recent years, states and the federal government have increasingly touted these as an alternative or safety net for women. Many have even shifted money toward them and away from other facilities such as Planned Parenthood, which typically provides a wider range of services.

According to Echevarria, these centers often work with local agencies to help women find housing, health care, jobs and even transportation. They also provide formula, maternity and baby clothes, diapers and other essentials free of charge.

The downside is that, in some cases, services at these “crisis pregnancy centers” can come with strings attached.

An investigation by Vox found that at some, prenatal and other free services were only for available if patients took parenting workshops or classes, some of which had a religious component.

Some women told Vox they found the required instruction troubling, with one saying of a parenting video, “it hurt me.”

A 2018 publication by the American Medical Association Journal of Ethics also called crisis pregnancy centers “legal, but unethical” that pass themselves off as legitimate clinics but are exempt from the regulatory oversight that applies to other health care facilities.

“They strive to give the impression that they are clinical centers, offering legitimate medical services and advice, yet they are exempt from regulatory, licensure, and credentialing oversight that apply to health care facilities. “Because the religious ideology of these centers’ owners and employees takes priority over the health and well-being of the women seeking care at these centers, women do not receive comprehensive, accurate, evidence-based clinical information about all available options,” the report says. “Although crisis pregnancy centers enjoy First Amendment rights protections, their propagation of misinformation should be regarded as an ethical violation that undermines women’s health.”

According to Echevarria, the services provided at most private centers are usually grounded in a right-to-life ideology and, as a result, are often condemned by abortion-rights activists.

“Many women who have had an abortion feel that if they had someone in their corner saying that they could raise a child and finish college or raise a child and pursue employment opportunities, then they would have given birth and kept their child,” Echevarria said. “Pregnancy centers can provide this real-world support.”

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legislative session, the ongoing policy wars against abortion and the facilities that provide them are already heating up in several states

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ACROSS AMERICA — Only a handful of weeks into the 2021 legislative session, the ongoing policy wars against abortion and the facilities that provide them are already heating up in several states across the country. It’s been nearly a half-century since the U.S. Supreme Court handed down its landmark ruling in the case of Roe v. Wade, which granted women a constitutional right to obtain an abortion. Yet in the decades since that ruling, states have spent significant time battling its provisions. From 2011 to 2017, 32 U.S. states enacted a total of 394 restrictions, most of which regulate or limit when, under what circumstances, and even if a woman may obtain an abortion. This year is shaping up to be no different. Since the start of the 2021 legislative season in January, more than 140 anti-abortion bills have been introduced in statehouses across the country, according to Rachel Sussman, vice president of state policy and advocacy for Planned Parenthood Federation of America. The end result: a tangled web of abortion policy that lawmakers continue to spin, and a significant reduction in women’s access to abortion services. “Over the past decade, there has been a jolt towards harmful, politically motivated abortion restrictions from politicians across the country,” Sussman said. Yet nearly a year into the coronavirus pandemic, many have lost more than just access to an abortion clinic. They’ve lost a vital lifeline to a suite of medical services that prevent unwanted pregnancies, provide life-saving diagnoses and help stop the spread of communicable diseases. Ultimately, much of the legislation has further pushed basic health care out of reach, especially for people with low incomes, and those living in rural or minority communities. Lawmakers Battle A Declining Issue The legislative push comes as the number of women receiving the procedure is declining. Centers for Disease Control and Prevention data shows abortions declined 22 percent over a decade, to nearly 620,000 in 2018 — or 11.3 per every 1,000 women ages 15 to 44. While it reflects slightly different data, a 2019 report by the Guttmacher Institute underscores the CDC’s findings. Report authors also took their research a step further, suggesting that legislation is not the key driver of the decline in abortions. Instead, they cited a broader decline in pregnancies, and said it was likely a result of increased access to birth control since the Affordable Care Act was enacted in 2011. “What’s true is that increasing people’s access to affordable and effective methods of birth control leads to fewer abortions,” Sussman said. Despite the decrease, abortion foes continue to target health care facilities that provide these services. Between 2011 and 2017, the number of clinics providing abortion in the United States declined by about 4 percent, according to the Guttmacher Institute. The decrease seems low, yet some areas of the country were hit harder than others. During the same period, the South saw a net decline of 50 clinics, with 25 in Texas alone. The Midwest lost 33 clinics, including nine each in Iowa, Michigan and Ohio. Seven clinics shuttered in Western states. By contrast, Northeast states added 59 clinics, mostly in New Jersey and New York. The South and the Midwest also had the largest share of new abortion restrictions during that period — nearly 86 percent of total enacted restrictions were in those two regions. Today, five states — Mississippi, Missouri, North Dakota, South Dakota and West Virginia — have only one remaining abortion provider each. Despite the election of Democratic President Joe Biden and Vice President Kamala Harris, 29 states currently have legislatures where anti-abortion politicians hold the majority, according to Sussman. Of the legislation introduced this session, 40 percent involves a form of abortion ban. Kansas is an extreme example. There, voters will decide in 2022 whether the state’s constitution protects abortion rights under a ballot measure approved by the state Senate. And in South Carolina, a bill that would ban abortion before most people even know they’re pregnant was fast-tracked through the state’s Legislature only to be blocked by a federal judge a day after it went into effect. “Politicians are wasting no time attacking access to sexual and reproductive health care,” Sussman said. “Some are still doing everything they can to take control of our bodies, lives and futures.” Who Stands To Lose Most Perhaps the most notable provider of sexual health and reproductive services, Planned Parenthood has more than 49 affiliates that operate 600 health care centers across the nation. Annually, the organization provides sexual and reproductive health services to more than 2.4 million people, 39 percent of whom are people of color. Of those, more than 541,000 patients identify as Latino and 395,000 as Black. More than 297,000 male patients also receive services. Finally, Planned Parenthood also provides gender-affirming hormone therapy for transgender patients in 31 states. In 2018, of Planned Parenthood patients who reported their income, nearly 75 percent were living at or below 150 percent of the federal poverty level — the equivalent of $37,650 a year for a family of four. “Patients don’t come to us to make a political statement,” Sussman of Planned Parenthood said. “They come to get compassionate, expert care and education.” Still, Planned Parenthood has frequently been the target of both state and federal lawmakers. In 2019, Planned Parenthood dropped out of a $260 million federal family planning program rather than comply with what it called a “gag rule” imposed by the Trump administration on abortion referrals. The order would have prohibited health clinics from receiving federal funds under Title X if abortions were performed at the facility or if specialists referred patients to centers where they could get an abortion. The administration made the call despite the Hyde Amendment which, passed in 1976, prohibits federal funding from directly paying for abortions. While some states stepped in to cover the lost funding, others did not. In total, providers in 34 states were forced out of the program, according to Planned Parenthood, prompting more than 1.5 million people across the country to lose access to Title X-supported services such as affordable birth control and sexually transmitted infection testing. According to the organization’s 2018-19 annual report, abortions comprised only 4 percent of Planned Parenthood’s provided services, while sexually transmitted infection testing and treatment comprised 50 percent, contraception made up 26 percent, and 13 percent was attributed to other women’s health services such as well-woman exams and prenatal care. Many of those who lost access to these crucial services were likely women of color. According to a 2018 fact sheet by the National Latina Institute for Reproductive Health, women of color make up more than half, and Latinas more than a third, of all Title X patients. “People don’t turn to politicians for advice about cancer screenings or STI treatment,” Sussman said. “The bottom line is that Planned Parenthood has been around for over 100 years, and we’re not going anywhere.” Anti-Abortion Groups Keep Fighting While Planned Parenthood is gearing up to challenge several pieces of 2021 legislation, anti-abortion groups are lauding the efforts already being made by lawmakers this session. National Right to Life, a federation with 50 state affiliates and more than 3,000 local affiliates, was founded in 1968 with the goal of creating a national organization to deal with life issues on the federal level. The organization’s oldest affiliate, Virginia Society for Human Life, was founded in 1967. While National Right For Life is most known for its stance against abortion, the organization also provides education and lobbies on legislation pertaining to other life issues such as infanticide, assisted suicide and euthanasia. While the organization works at a national level, its affiliates provide support, testimony and other help to states regarding anti-abortion legislation. National Right To Life is also looking ahead to 2021, and leaders are anticipating “significant challenges” at the federal level, according to spokesperson Laura Echevarria. Among them is the possible certification of the 1972 Equal Rights Amendment to the U.S. Constitution. In January 2020, Virginia became the 38th state to ratify the amendment, which guarantees equal rights for women. The vote followed ratifications by Nevada in 2017 and Illinois in 2018 after four decades of inactivity. Hurdles remain in the path of the amendment’s certification, however. The ratification deadlines that Congress set after it approved the amendment have lapsed, and five states have acted to rescind their prior approval. The Equal Rights Amendment has come under fire by anti-abortion proponents, some of whom claim that it would require taxpayer-funded abortions. Since only women can have abortions, any restrictions on the procedure could be deemed unconstitutional under the amendment. “Everyone knows this renewed effort isn’t about women’s rights,” the office of House Republican Whip Steve Scalise said in a February 2020 report by Politico, summarizing the message sent by the GOP caucus. “It’s about eliminating federal and state life protections and ushering in an era of taxpayer funding of abortion.” While the certification of the amendment ultimately passed in the Democratic-controlled House of Representatives, it was dead on arrival in the Republican-controlled Senate. Following the 2020 election, Democrats now hold a razor-thin majority in the Senate. “We see the right to life as the leading human rights issue of our day,” Echevarria said. “Without abortion-neutralizing language, the Equal Rights Amendment would be used to expand abortion on demand. We’ve seen this happen in states that use the same language in state ERAs.” When it comes to how anti-abortion legislation might affect access to free and low-cost health care, Echevarria said that National Right To Life typically doesn’t take a stance on health care issues unless it’s somehow related to taxpayer funding of abortion or health care plans that are forced to cover abortions. If a woman is in need of such health care, Echevarria recommended she seek out one of more than 2,700 pregnancy centers across the United States that provide free services to women in need, most of which are manned primarily by volunteers and financially supported with private funds from individuals, religious organizations and businesses. In recent years, states and the federal government have increasingly touted these as an alternative or safety net for women. Many have even shifted money toward them and away from other facilities such as Planned Parenthood, which typically provides a wider range of services. According to Echevarria, these centers often work with local agencies to help women find housing, health care, jobs and even transportation. They also provide formula, maternity and baby clothes, diapers and other essentials free of charge. The downside is that, in some cases, services at these “crisis pregnancy centers” can come with strings attached. An investigation by Vox found that at some, prenatal and other free services were only for available if patients took parenting workshops or classes, some of which had a religious component. Some women told Vox they found the required instruction troubling, with one saying of a parenting video, “it hurt me.” A 2018 publication by the American Medical Association Journal of Ethics also called crisis pregnancy centers “legal, but unethical” that pass themselves off as legitimate clinics but are exempt from the regulatory oversight that applies to other health care facilities. “They strive to give the impression that they are clinical centers, offering legitimate medical services and advice, yet they are exempt from regulatory, licensure, and credentialing oversight that apply to health care facilities. “Because the religious ideology of these centers’ owners and employees takes priority over the health and well-being of the women seeking care at these centers, women do not receive comprehensive, accurate, evidence-based clinical information about all available options,” the report says. “Although crisis pregnancy centers enjoy First Amendment rights protections, their propagation of misinformation should be regarded as an ethical violation that undermines women’s health.” According to Echevarria, the services provided at most private centers are usually grounded in a right-to-life ideology and, as a result, are often condemned by abortion-rights activists. “Many women who have had an abortion feel that if they had someone in their corner saying that they could raise a child and finish college or raise a child and pursue employment opportunities, then they would have given birth and kept their child,” Echevarria said. “Pregnancy centers can provide this real-world support.” https://247sports.com/college/utah/board/102583/contents/soccerstreams-atletico-madrid-vs-chelsea-live-stream-reddit-hd-161352535/ https://247sports.com/college/utah/board/102583/contents/soccerstreams-atletico-vs-chelsea-live-stream-reddit-hd-161352545/ https://247sports.com/college/utah/board/102583/contents/watch-atletico-madrid-vs-chelsea-free-live-stream-reddit-161352561/ 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The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved

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Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
The US Food and Drug Administration authorized Johnson & Johnson’s Covid-19 vaccine Saturday. It is the first single dose Covid-19 vaccine available in the US, and is one that “checks nearly all the boxes.”
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Why Americans shouldn’t turn their noses up at Johnson & Johnson’s vaccine
Why Americans shouldn’t turn their noses up at Johnson & Johnson’s vaccine
With more than 28.5 million confirmed Covid-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can’t come soon enough.
“A third safe and effective vaccine is very welcome news,” Andy Slavitt, the White House’s senior for Covid Response, tweeted on Friday.
The vaccine, made by Janssen, J&J’s vaccine arm, is safe and effective, and it’s considered flexible. It’s a single dose, and it doesn’t require special storage.
The vaccine is authorized for people ages 18 and older.
“We need a vaccine that can be quickly mass produced,” Dr. Greg Poland, head of the Mayo Clinic’s Vaccine Research Group, said Friday. “We’d want to see a reasonable duration of efficacy and protection.
“The Janssen vaccine candidate checks nearly all the boxes.”
They thought they were being vaccinated. It was a trial.
They thought they were being vaccinated. It was a trial.
The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical Covid-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.
“One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue,” Dr. Paul Offit, a vaccine adviser to the FDA, told CNN’s Wolf Blitzer on Friday.
The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.
Overall, non-fatal serious adverse events were infrequent, according to the FDA’s analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the US Centers for Disease Control and Prevention.
When will the US reach herd immunity and what will it look like?
When will the US reach herd immunity and what will it look like?
More research is needed, but the FDA analysis also hinted that the J&J vaccine may help prevent asymptomatic infections.
A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease — not just keep the vaccinated from getting sick.
With so much positive data, an independent group of advisers voted unanimously on Friday to recommend the emergency use authorization of the J&J vaccine.
Biden’s stimulus effort hits the runway
Biden’s stimulus effort hits the runway
“I think it’s a relatively easy call. It clearly gets way over the bar, and it’s nice to have a single-dose vaccine,” Dr. Eric Rubin, a member of the committee who is also the editor in chief of The New England Journal of Medicine and a professor at the Harvard T.H. Chan School of Public Health, said after the vote.
There is some concern that because the public has heard that the shot is only 72% protective in the US, and the Pfizer and Moderna Covid-19 vaccines are about 95% protective, some will think this is a “second class” vaccine, but the experts say those numbers are highly misleading.
“It’s difficult to make an apples-to-apples comparison between vaccines authorized based on data collected before new variants are believed to have been in widespread circulation,” said Sarah Christopher, the policy advocacy director at the National Women’s Health Network. Christopher spoke during the public comment section of the FDA’s advisory meeting on Friday.
Single Pfizer vaccine shot provides strong protection for those who’ve had Covid-19, UK studies suggest
Single Pfizer vaccine shot provides strong protection for those who’ve had Covid-19, UK studies suggest
The Pfizer and Moderna Covid-19 vaccines were tested earlier in the pandemic when there were fewer known variants. FDA research found that the majority of the cases that happened during the South African part of the J&J trial came from a newer and possibly more contagious variant.
Public health experts say people should take whatever shot is first available to them.
“If I had a J&J vaccine available today and a Moderna vaccine available tomorrow, I would be happy to take the J&J today. I don’t feel like I would need to wait. They are all terrific vaccines for the things that we care about,” Dr. Ashish Jha, dean of the Brown University School of Public Health, told a House Ways and Means Health Subcommittee hearing Friday.
Doctor: I’m worried the Olympics can’t be made safe against Covid
Doctor: I’m worried the Olympics can’t be made safe against Covid
Experts have said variants may fuel a surge of cases in the spring in the US, and say that’s one reason why it’s important to get as many people vaccinated as quickly as possible.
“We’ll be seeing how much of an impact the variants have and how best these vaccines can address them, whether it will be booster doses, or other vaccines,” said Dr. Aditya Gaur, a co-lead investigator on the J&J trial at St. Jude in Memphis. “But I think one could not have asked for better from this first round of vaccine development from a standpoint of how quickly it has happened and how quickly it has started to roll out around the world.”
On Sunday, the CDC’s Advisory Committee on Immunization Practices, known as ACIP, will meet to set the guidelines for who should get the vaccine. Their vote is scheduled for 3 p.m. ET.
From there, the much needed vaccine could start rolling out to vaccine centers around the country.
While the initial supply is limited — the company says it only has about 4 million doses of its vaccine ready to ship “immediately” — it should have 20 million ready by the end of March.
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The advancement of the Johnson & Johnson coronavirus vaccine is “really good news for the world,” Dr. Francis Collins, director of the National Institutes of Health, told CNN’s Wolf Blitzer on Friday. Even with cases in the US declining recently, the pandemic is far from over. “The best way to get done is with this vaccine being added to the others.”

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe/critical in the vaccine group versus 34 cases in the placebo group.

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

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General

The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic

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Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
The US Food and Drug Administration authorized Johnson & Johnson’s Covid-19 vaccine Saturday. It is the first single dose Covid-19 vaccine available in the US, and is one that “checks nearly all the boxes.”
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Why Americans shouldn’t turn their noses up at Johnson & Johnson’s vaccine
Why Americans shouldn’t turn their noses up at Johnson & Johnson’s vaccine
With more than 28.5 million confirmed Covid-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can’t come soon enough.
“A third safe and effective vaccine is very welcome news,” Andy Slavitt, the White House’s senior for Covid Response, tweeted on Friday.
The vaccine, made by Janssen, J&J’s vaccine arm, is safe and effective, and it’s considered flexible. It’s a single dose, and it doesn’t require special storage.
The vaccine is authorized for people ages 18 and older.
“We need a vaccine that can be quickly mass produced,” Dr. Greg Poland, head of the Mayo Clinic’s Vaccine Research Group, said Friday. “We’d want to see a reasonable duration of efficacy and protection.
“The Janssen vaccine candidate checks nearly all the boxes.”
They thought they were being vaccinated. It was a trial.
They thought they were being vaccinated. It was a trial.
The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical Covid-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.
“One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue,” Dr. Paul Offit, a vaccine adviser to the FDA, told CNN’s Wolf Blitzer on Friday.
The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.
Overall, non-fatal serious adverse events were infrequent, according to the FDA’s analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the US Centers for Disease Control and Prevention.
When will the US reach herd immunity and what will it look like?
When will the US reach herd immunity and what will it look like?
More research is needed, but the FDA analysis also hinted that the J&J vaccine may help prevent asymptomatic infections.
A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease — not just keep the vaccinated from getting sick.
With so much positive data, an independent group of advisers voted unanimously on Friday to recommend the emergency use authorization of the J&J vaccine.
Biden’s stimulus effort hits the runway
Biden’s stimulus effort hits the runway
“I think it’s a relatively easy call. It clearly gets way over the bar, and it’s nice to have a single-dose vaccine,” Dr. Eric Rubin, a member of the committee who is also the editor in chief of The New England Journal of Medicine and a professor at the Harvard T.H. Chan School of Public Health, said after the vote.
There is some concern that because the public has heard that the shot is only 72% protective in the US, and the Pfizer and Moderna Covid-19 vaccines are about 95% protective, some will think this is a “second class” vaccine, but the experts say those numbers are highly misleading.
“It’s difficult to make an apples-to-apples comparison between vaccines authorized based on data collected before new variants are believed to have been in widespread circulation,” said Sarah Christopher, the policy advocacy director at the National Women’s Health Network. Christopher spoke during the public comment section of the FDA’s advisory meeting on Friday.
Single Pfizer vaccine shot provides strong protection for those who’ve had Covid-19, UK studies suggest
Single Pfizer vaccine shot provides strong protection for those who’ve had Covid-19, UK studies suggest
The Pfizer and Moderna Covid-19 vaccines were tested earlier in the pandemic when there were fewer known variants. FDA research found that the majority of the cases that happened during the South African part of the J&J trial came from a newer and possibly more contagious variant.
Public health experts say people should take whatever shot is first available to them.
“If I had a J&J vaccine available today and a Moderna vaccine available tomorrow, I would be happy to take the J&J today. I don’t feel like I would need to wait. They are all terrific vaccines for the things that we care about,” Dr. Ashish Jha, dean of the Brown University School of Public Health, told a House Ways and Means Health Subcommittee hearing Friday.
Doctor: I’m worried the Olympics can’t be made safe against Covid
Doctor: I’m worried the Olympics can’t be made safe against Covid
Experts have said variants may fuel a surge of cases in the spring in the US, and say that’s one reason why it’s important to get as many people vaccinated as quickly as possible.
“We’ll be seeing how much of an impact the variants have and how best these vaccines can address them, whether it will be booster doses, or other vaccines,” said Dr. Aditya Gaur, a co-lead investigator on the J&J trial at St. Jude in Memphis. “But I think one could not have asked for better from this first round of vaccine development from a standpoint of how quickly it has happened and how quickly it has started to roll out around the world.”
On Sunday, the CDC’s Advisory Committee on Immunization Practices, known as ACIP, will meet to set the guidelines for who should get the vaccine. Their vote is scheduled for 3 p.m. ET.
From there, the much needed vaccine could start rolling out to vaccine centers around the country.
While the initial supply is limited — the company says it only has about 4 million doses of its vaccine ready to ship “immediately” — it should have 20 million ready by the end of March.
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The advancement of the Johnson & Johnson coronavirus vaccine is “really good news for the world,” Dr. Francis Collins, director of the National Institutes of Health, told CNN’s Wolf Blitzer on Friday. Even with cases in the US declining recently, the pandemic is far from over. “The best way to get done is with this vaccine being added to the others.”

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe/critical in the vaccine group versus 34 cases in the placebo group.

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

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The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination

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Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
The US Food and Drug Administration authorized Johnson & Johnson’s Covid-19 vaccine Saturday. It is the first single dose Covid-19 vaccine available in the US, and is one that “checks nearly all the boxes.”
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Why Americans shouldn’t turn their noses up at Johnson & Johnson’s vaccine
Why Americans shouldn’t turn their noses up at Johnson & Johnson’s vaccine
With more than 28.5 million confirmed Covid-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can’t come soon enough.
“A third safe and effective vaccine is very welcome news,” Andy Slavitt, the White House’s senior for Covid Response, tweeted on Friday.
The vaccine, made by Janssen, J&J’s vaccine arm, is safe and effective, and it’s considered flexible. It’s a single dose, and it doesn’t require special storage.
The vaccine is authorized for people ages 18 and older.
“We need a vaccine that can be quickly mass produced,” Dr. Greg Poland, head of the Mayo Clinic’s Vaccine Research Group, said Friday. “We’d want to see a reasonable duration of efficacy and protection.
“The Janssen vaccine candidate checks nearly all the boxes.”
They thought they were being vaccinated. It was a trial.
They thought they were being vaccinated. It was a trial.
The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical Covid-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.
“One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue,” Dr. Paul Offit, a vaccine adviser to the FDA, told CNN’s Wolf Blitzer on Friday.
The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.
Overall, non-fatal serious adverse events were infrequent, according to the FDA’s analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the US Centers for Disease Control and Prevention.
When will the US reach herd immunity and what will it look like?
When will the US reach herd immunity and what will it look like?
More research is needed, but the FDA analysis also hinted that the J&J vaccine may help prevent asymptomatic infections.
A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease — not just keep the vaccinated from getting sick.
With so much positive data, an independent group of advisers voted unanimously on Friday to recommend the emergency use authorization of the J&J vaccine.
Biden’s stimulus effort hits the runway
Biden’s stimulus effort hits the runway
“I think it’s a relatively easy call. It clearly gets way over the bar, and it’s nice to have a single-dose vaccine,” Dr. Eric Rubin, a member of the committee who is also the editor in chief of The New England Journal of Medicine and a professor at the Harvard T.H. Chan School of Public Health, said after the vote.
There is some concern that because the public has heard that the shot is only 72% protective in the US, and the Pfizer and Moderna Covid-19 vaccines are about 95% protective, some will think this is a “second class” vaccine, but the experts say those numbers are highly misleading.
“It’s difficult to make an apples-to-apples comparison between vaccines authorized based on data collected before new variants are believed to have been in widespread circulation,” said Sarah Christopher, the policy advocacy director at the National Women’s Health Network. Christopher spoke during the public comment section of the FDA’s advisory meeting on Friday.
Single Pfizer vaccine shot provides strong protection for those who’ve had Covid-19, UK studies suggest
Single Pfizer vaccine shot provides strong protection for those who’ve had Covid-19, UK studies suggest
The Pfizer and Moderna Covid-19 vaccines were tested earlier in the pandemic when there were fewer known variants. FDA research found that the majority of the cases that happened during the South African part of the J&J trial came from a newer and possibly more contagious variant.
Public health experts say people should take whatever shot is first available to them.
“If I had a J&J vaccine available today and a Moderna vaccine available tomorrow, I would be happy to take the J&J today. I don’t feel like I would need to wait. They are all terrific vaccines for the things that we care about,” Dr. Ashish Jha, dean of the Brown University School of Public Health, told a House Ways and Means Health Subcommittee hearing Friday.
Doctor: I’m worried the Olympics can’t be made safe against Covid
Doctor: I’m worried the Olympics can’t be made safe against Covid
Experts have said variants may fuel a surge of cases in the spring in the US, and say that’s one reason why it’s important to get as many people vaccinated as quickly as possible.
“We’ll be seeing how much of an impact the variants have and how best these vaccines can address them, whether it will be booster doses, or other vaccines,” said Dr. Aditya Gaur, a co-lead investigator on the J&J trial at St. Jude in Memphis. “But I think one could not have asked for better from this first round of vaccine development from a standpoint of how quickly it has happened and how quickly it has started to roll out around the world.”
On Sunday, the CDC’s Advisory Committee on Immunization Practices, known as ACIP, will meet to set the guidelines for who should get the vaccine. Their vote is scheduled for 3 p.m. ET.
From there, the much needed vaccine could start rolling out to vaccine centers around the country.
While the initial supply is limited — the company says it only has about 4 million doses of its vaccine ready to ship “immediately” — it should have 20 million ready by the end of March.
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The advancement of the Johnson & Johnson coronavirus vaccine is “really good news for the world,” Dr. Francis Collins, director of the National Institutes of Health, told CNN’s Wolf Blitzer on Friday. Even with cases in the US declining recently, the pandemic is far from over. “The best way to get done is with this vaccine being added to the others.”

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe/critical in the vaccine group versus 34 cases in the placebo group.

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

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