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urged Russians to stand up to the Kremlin in a fiery speech mixing references to the Bible and “Harry Potter.”

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Moscow court rejects opposition leader Navalny’s appeal
A Moscow court has rejected Russian opposition leader Alexei Navalny’s appeal of his prison sentence and another judge later has ordered him to pay a fine for defaming a World War II veteran

By VLADIMIR ISACHENKOV Associated Press
20 February 2021, 23:32
• 5 min read

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MOSCOW — A Moscow court on Saturday rejected Russian opposition leader Alexei Navalny’s appeal of his prison sentence, even as the country faced an order from a top European rights court to free the Kremlin’s most prominent foe.

A few hours later, a judge in a separate case ordered Navalny to pay a fine for defaming a World War II veteran.

During the first court hearing, Navalny urged Russians to stand up to the Kremlin in a fiery speech mixing references to the Bible and “Harry Potter.”

Navalny, 44, an anti-corruption crusader and President Vladimir Putin’s most vocal critic, was arrested on Jan. 17 upon returning from Germany, where he spent five months recovering from a nerve-agent poisoning that he blames on the Kremlin. Russian authorities have rejected the accusation.

Earlier this month, Navalny was sentenced to two years and eight months in prison for violating terms of his probation while convalescing in Germany. He appealed the sentence and asked to be released. A Moscow City Court judge instead reduced the prison sentence to just over 2 1/2 years, deducting a month-and-a-half that Navalny spent under house arrest in early 2015.

The sentence stems from a 2014 embezzlement conviction that Navalny has rejected as fabricated and the European Сourt of Human Rights has ruled to be unlawful.

Navalny has been held in Moscow’s Matrosskaya Tishina prison, but Russian news reports said that after losing his appeal, he would likely be sent to a prison in the western part of Russia within the next few days to serve out his sentence.

His arrest and imprisonment have fueled a huge wave of protests across Russia. Authorities responded with a sweeping crackdown, detaining about 11,000 people, many of whom were fined or given jail terms ranging from seven to 15 days.

In his speech at the hearing, Navalny referenced the Bible as well as “Harry Potter” and the animated sitcom “Rick and Morty” as he urged Russians to resist pressure from authorities and challenge the Kremlin to build a fairer and more prosperous country.

“The government’s task is to scare you and then persuade you that you are alone,” he said. “Our Voldemort in his palace also wants me to feel cut off,” he added, in a reference to Putin.

“To live is to risk it all,” he said, citing “Rick and Morty.” “Otherwise, you’re just an inert chunk of randomly assembled molecules drifting wherever the universe blows you.”

Navalny also addressed the judge and the prosecutor, arguing that they could have a much better life in a new Russia.

“Just imagine how wonderful life would be without constant lying,” he said. “Imagine how great it would be to work as a judge … when no one would be able to call you and give you directions what verdicts to issue.”

He insisted that he was unable to report to the authorities in line with his probation requirements while he was convalescing in Germany after his poisoning, emphasizing that he returned to Russia immediately after his health allowed.

“I wasn’t hiding,” he said. “The entire world knew where I was.”

Navalny said he was an atheist before but has come to believe in God, adding that his faith helped him face his challenges. He said he believed the Bible phrase that those who hunger and thirst for righteousness are blessed, and that he felt no regret about deciding to return home to Russia.

“Even though our country is built on injustice and we all constantly face injustice … we also see that millions of people, tens of millions of people, want righteousness,” Navalny told the court. “They want the righteousness and sooner or later they will have it.”

Asked about the impact of Navalny’s prison sentence on Russia’s politics, Kremlin spokesman Dmitry Peskov told reporters that the country’s “rich and multifaceted” political scene will develop regardless of the verdict.

Russia has rejected Western criticism of Navalny’s arrest and the crackdown on demonstrations as meddling in its internal affairs.

In a ruling Tuesday, the European Court of Human Rights ordered the Russian government to release Navalny, citing “the nature and extent of risk to the applicant’s life.” The Strasbourg-based court noted that Navalny has contested Russian authorities’ argument that they had taken sufficient measures to safeguard his life and well-being in custody following the nerve agent attack.

The Russian government has rebuffed the European court’s demand, describing the ruling as unlawful and “inadmissible” meddling in Russia’s affairs. Russian state news agency RIA Novosti reported that the Russian Justice Ministry on Saturday sent a letter to the court asking it to revise its order.

In the past, Moscow has abided by European Court of Human Rights rulings awarding compensations to Russian citizens who have contested verdicts in Russian courts, but it never faced a demand by the European court to set a convict free.

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In a sign of its long-held annoyance with the Strasbourg court’s verdicts, Russia last year adopted a constitutional amendment declaring the priority of national legislation over international law. Russian authorities might now use that provision to reject the ECHR’s ruling.

After losing his appeal, Navalny had a second court hearing on charges of slandering a World War II veteran and was ordered to pay a fine of 850,000 rubles (about $11,500). Prosecutors asked for a 950,000-rubles ($13,000) fine.

Navalny called the 94-year-old veteran and other people featured in a pro-Kremlin video last year as “corrupt stooges,” “people without conscience” and “traitors.” He rejected the slander charges, describing them as part of official efforts to disparage him.

Navalny said at the hearing that his accusers “will burn in hell.”

Request to allow abortion waiting period in Tennessee denied
A federal court has denied a request to keep Tennessee’s 48-hour waiting period for abortions in effect while it hears an appeal of a lower court’s ruling that found the law unconstitutional

By TRAVIS LOLLER Associated Press
20 February 2021, 05:48
• 2 min read

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NASHVILLE, Tenn. — A federal court on Friday denied a request to keep Tennessee’s 48-hour waiting period for abortions in effect while it hears an appeal of a lower court’s ruling that found it unconstitutional.

U.S. District Judge Bernard Friedman ruled in October that Tennessee’s waiting period law serves no legitimate purpose while placing a substantial burden on women who seek abortions in Tennessee. The 2015 law required women to make two trips to an abortion clinic, first for mandatory counseling and then for the abortion at least 48 hours later.

Directors of Tennessee abortion clinics testified at the 2019 trial that the two-visit requirement posed logistical challenges that caused abortions to be delayed far beyond the 48 hours required by law. The delay pushed some women beyond the time when they could have medication abortions, which have lower risks of complications than surgical abortions. A few women were pushed beyond the time when they could receive an abortion altogether.

Tennessee had asked the 6th U.S. Circuit Court of Appeals to put aside Friedman’s ruling until the state’s appeal is resolved, arguing that Friedman erred in balancing the law’s benefits with its burdens, applying the wrong legal standard. In a split 2-1 decision, a panel of 6th Circuit judges wrote that regardless of the analysis, the facts seem to point to the law posing an undue burden on women seeking abortion in Tennessee. The panel concluded that the state was not likely to succeed in its appeal and so was not entitled to have Friedman’s ruling put on hold.

Writing for the majority, Judge Karen Nelson Moore said the Tennessee law “appears to be yet another unnecessary, unjustified, and unduly burdensome state law that stands between women and their right to an abortion.”

Judge Amul Thapar disagreed, writing that “the Supreme Court says that waiting periods are constitutional.”

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General

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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Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

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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