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Video from CNN affiliate KWTX showed multiple police and fire crews on the scene where the building appeared to be completely engulfed. CNN has contacted the Killeen Fire Department for additional details and is awaiting comment. State leaders respond to water crisis

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exans weathering harsh winter conditions will get some relief from the cold on Saturday, although many in the state are still without basic utilities.

Saturday morning temperatures may be as low as 20 degrees for many inland locations, including Dallas and College Station, but the welcome return of onshore winds and full sunshine will warm the state into the 50’s and 60’s in the afternoon, said CNN meteorologist Derek Van Dam. Most of the state will stay above freezing after that initial thaw.
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The brutal temperatures, ice and snow once caused millions of people in Texas to lose power, but as of early Saturday morning, only about 70,000 people in the state were left in the dark, according to Poweroutage.us, a website that tracks US power outages. However, more than 14.4 million people — half the state’s population — had reported disruptions in their water service in 192 of the state’s 254 counties as of Saturday afternoon, according to Gary Rasp, a spokesman for the Texas Commission on Environmental Quality.
By Saturday, Houston’s water system was at “normal operating pressure citywide” but a boil advisory remained in effect, according to Carol Haddock, Houston Public Works director. Mayor Sylvester Turner said the advisory could be lifted by Monday but warned that it “could be a day or two on either end.”

Cold temperatures to recede for Texas this weekend 01:30
Austin’s water utility said it was more than halfway to restoring minimum water pressure to serve the city. The system requires a minimum of 100 million gallons in storage and had more than 50 million gallons on Saturday morning, according to the water utility. City officials said service could be back by the end of the weekend.
President Joe Biden has approved a major disaster declaration for Texas, unlocking additional federal resources to assist the state’s recovery, the White House said in a statement Saturday.
Texas Gov. Greg Abbott called the federal assistance “an important first step” but said it was a “partially” approved request. The Republican governor had requested both individual and public assistance for all 254 counties and the Biden administration approved individual assistance in 77 counties and public assistance in all counties, according to a statement from Abbott’s office.
Strangers took in a delivery driver for 5 days after she was stranded in the Texas storm
Strangers took in a delivery driver for 5 days after she was stranded in the Texas storm
The Public Utility Commission of Texas said Saturday it was investigating “factors that combined with the devastating winter weather to disrupt the flow of power to millions of Texas homes.”
Abbott convened an emergency meeting to look at what state officials said were “unreasonable spikes” in energy bills in the aftermath of the storm.
“It is unacceptable for Texans who suffered through days in the freezing cold without electricity or heat to now be hit with skyrocketing energy costs,” the governor said in a statement.
Texas mayor has lost faith in state political leaders
Larry Wallace, mayor of the city of Manor outside of Austin, told CNN Saturday that thousands in his city still had no electricity or water. He said he was frustrated with the poor communication from utility companies and state political leaders.
“I’ve lost all faith in senior leadership,” he said.
In Austin, Smita Pande told CNN she lost power to her home early in the week, and she and her husband stayed at a friend’s house until the water went out there, too. The group then traveled to another friend’s house that had operating utilities until their water supply failed as well. The three households returned to Pande’s home, where they relied on collecting snow to melt in order to flush their toilets.
Although power is now restored, Pande heard that the wait for water may last for a few days.
“At this point we’re planning on getting water in a week. We have to assume the worst-case scenario,” Pande told CNN’s Don Lemon in an interview Friday. “We’re hearing two or three days at this point. We’re going to hope for the best.”
Bottled ater is loaded into a vehicle at a city of Houston water distribution site Friday. The location provided bottled water to residents in need while the city remains on a boil water notice.
Bottled ater is loaded into a vehicle at a city of Houston water distribution site Friday. The location provided bottled water to residents in need while the city remains on a boil water notice.
Race to restore utilities
Austin resident Jenn Studebaker said power was back but her family slept around a fireplace they had never used to keep warm most of the week, using chairs and pieces of bookcases as fire wood. And they used melting snow in their bathtub for drinking water and filling up their toilet.
“Everyone is just thinking, If we can just make it one more day,” she said.
By Saturday afternoon, fewer than 10,000 power utility customers remained in the dark, compared to high of about 220,000 earlier in the week, according to city officials.
5 ways you can help those facing homelessness in the cold
5 ways you can help those facing homelessness in the cold
With burst pipes and power outages, Austin Mayor Steve Adler told CNN that his city needs water more than any other resource. When the power grid failed, it affected the main water treatment plant and the city’s reservoir was lost, Adler told CNN’s Poppy Harlow. Those that do have water are under boil water advisories.
“This is a community of people that are scared and upset and angry,” Adler said. “We’re eventually going to need some better answers to why we’re here and how we prevent it from ever happening again. But for right now we’re just trying to get water.”
Dr. Schuwan Dorsey told CNN she lost power and water early Monday in Houston and resorted to sleeping with her two dogs in her car, intermittently turning the engine on to generate heat.
Her Life Alert bracelet was offline because her home’s electricity was out, Dorsey also said.
“I was in danger with my health,” Dorsey said Friday, noting that her power was on for a mere three minutes on Wednesday. Electricity has since returned yet she still has no water.
Many hospitals across the state are strained as well, with no running water, burst pipes, low pressure and boil water notices, according to a statement from Carrie Williams, spokesperson for the Texas Hospital Association.
Marie Maybou melts snow on her kitchen stove in Austin on Friday. She is using the water to flush her home’s toilets after the city water stopped running.
Marie Maybou melts snow on her kitchen stove in Austin on Friday. She is using the water to flush her home’s toilets after the city water stopped running.
Williams said that there are also issues with staffing as some employees have had to stay on-site in order to care for patients, putting a strain on food, linens and water. Provisions and medication stocks ran low, although there are some supply trucks moving Friday, Williams said.
Dr. Richina Bicette, associate medical director at Baylor College of Medicine in Houston, said the weather caused “a completely harrowing experience” for her Texas hospital.
“We were not prepared at all,” she told CNN Saturday. “The guidance we got before the storm was that, you know, it would be cold, roads would freeze, don’t drive. There was no suspicion we would be without electricity, with below-freezing temperatures outside or that people would be without water.”
Bicette said patients arriving at the hospital included people burned in fires and entire families with carbon monoxide poisoning. Patients who missed dialysis treatments and others who relied on electric medical equipment are showing up at the emergency room “very, very sick.”
How one Texas town avoided disaster during the storm

How one Texas town avoided disaster during the storm 02:57
“Things are getting to be a little scary and a little dangerous, because, again, we’re having such a high influx of sick patients coming in,” she said. “There aren’t enough staff to take care of these patients right now.”
As residents of the city of Killeen, Texas, were under water conservation conditions Friday night, fire crews battled a blaze that tore through a Hilton Garden Inn near Fort Hood, according to a tweet from the Killeen Police Department.
Video from CNN affiliate KWTX showed multiple police and fire crews on the scene where the building appeared to be completely engulfed. CNN has contacted the Killeen Fire Department for additional details and is awaiting comment.
State leaders respond to water crisis
Water disruptions aren’t expected to go away once the freezing temperatures do: frozen pipes have burst, but many are concerned even more pipes will as they thaw.
To address the breaks, Abbott announced Friday that he is working with the Texas State Board of Plumbing Examiners. More than 320 plumbers have renewed their plumbing license, Abbott said, and the plumbing board is coordinating with out-of-state companies to bring more personnel to Texas.
‘Thank God for The Texas Tribune’: Power crisis shines light on local news
‘Thank God for The Texas Tribune’: Power crisis shines light on local news
“We know that there will be great demand for plumbers today, tomorrow … this weekend, in the coming days,” the governor said. “We want to make sure that we do everything we possibly can to help you gain access to the plumbers that you need to solve your plumbing and leakage problems along those lines.”
The state is also boosting the testing of local water systems by partnering with the federal government and neighboring Arkansas, Abbott announced Friday.
Working with the US Environmental Protection Agency, the Texas Commission on Environmental Quality has set up three mobile water testing labs, accord to Abbott.

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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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