The latest on the Covid-19 pandemic in the US

By Melissa Mahtani, Melissa Macaya and Veronica Rocha, CNN

Updated 8:00 p.m. ET, September 17, 2021
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4:13 p.m. ET, September 17, 2021

FDA vaccine advisers reject Pfizer's booster request

From CNN’s Maggie Fox

The Food and Drug Administration headquarters in Silver Spring, Maryland.
The Food and Drug Administration headquarters in Silver Spring, Maryland. (Ting Shen/Xinhua/Getty Images)

Vaccine advisers to the US Food and Drug Administration rejected Pfizer’s application to add a third, booster dose of its coronavirus vaccine to the two-dose regimen. 

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee rejected the application by a vote of 16 to 2. But they reserved the right to amend the question being asked in a second round of voting.

The voting question: Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least six months after completion of the primary series for use in individuals 16 years of age and older?

Committee members were preparing to vote on a narrower approval – perhaps one that allowed booster doses for people 60 or 65 or older, or for people at high risk of exposure at work.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine.

“It is very important that the main message that we still transmit is that we have got to get everyone two doses. Everyone has got the get the primary series. This booster dose is not likely to make a big difference in the behavior of this pandemic.”

Dr. Sanjay Gupta: No, this is not what we were expecting

 

3:32 p.m. ET, September 17, 2021

FDA vaccine advisers have started voting

Members of the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee are now voting but they may modify the question they are voting on and vote again.

They are voting on this question: Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMINARNATY booster dose administered at least six months after completion of the primary series for use in individuals 16 years of age and older?

There will be discussion after the vote.

2:51 p.m. ET, September 17, 2021

FDA staff and advisers push back against Pfizer's case for Covid-19 booster doses

From CNN's Maggie Fox

Vaccine maker Pfizer got some strong pushback Friday in a meeting held to discuss the company’s application to approve booster doses of coronavirus vaccine. 

Vaccine advisers to the US Food and Drug Administration are meeting to discuss Pfizer’s request. The company said it has data showing both that immunity wanes six months or so after people are fully vaccinated with two doses, and also that adding a third, booster dose at six to eight months restores that immunity.

But Dr. Phil Krause, deputy director of the FDA’s Office of Vaccines Research and Review, noted that Pfizer was using data that had not been reviewed by experts.

“One of the issues in this is that much of the data that's been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA,” Krause told the meeting of the Vaccines and Related Biological Products Advisory Committee.

He pointed to one study being used by Pfizer to support its case. “If you take these numbers and put them together, you get an efficacy of 93.3% in the study,” he added. Yet Pfizer said the data suggested a drop in efficacy to 58%-61%. 

Pfizer Senior Vice President Dr. William Gruber said that analysis included waning of immunity over time. But Krause — who signed an unusual letter in the Lancet earlier this week saying there wasn’t yet enough evidence to justify boosters – said the study did not make that case clearly.

“This points out the complexity of this model and the importance of these data being reviewed,” Krause said.

One of the members of the independent committee was also critical. Dr. Michael Kurilla, an infectious disease specialist at the National Center for Advancing Translational Sciences, noted that the studies relied heavily on measurements of antibodies, without looking at other important aspects of immune response.

“It's a little disappointing that there's been very little reporting of the cellular immune responses and an entire focus on the neutralizing antisera,” Kurilla said. “Which clearly for that population at high risk is absolutely essential, but for the broad population in terms of their protection, which seems to be holding up well over time – (that) should be because of adequate cellular immune responses but we have no indication of that,” Kurilla added.

“So it's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease," he said.
2:28 p.m. ET, September 17, 2021

SOON: FDA vaccine advisers will vote on whether Covid-19 booster is needed

A senior living facility in Worcester, Pennsylvania, administers a third Covid-19 vaccine dose to its residents on August 25.
A senior living facility in Worcester, Pennsylvania, administers a third Covid-19 vaccine dose to its residents on August 25. (Hannah Beier/Bloomberg/Getty Images)

Vaccine advisers to the US Food and Drug Administration are expected to vote soon on whether many Americans need to start getting booster doses of coronavirus vaccine.

Pfizer received full approval for its vaccine from the FDA, so the request to add a booster dose is a supplement to that approval. The data being presented by Pfizer involves a booster given to its volunteers about six months after they finished their first two doses.

2:26 p.m. ET, September 17, 2021

CDC urges local and state health officials to wait to administer boosters until FDA and CDC sign off

From CNN’s Nadia Kounang

The US Centers for Disease Control and Prevention is urging state and local health officials to wait to administer vaccine booster doses until after the US Food and Drug Administration has OK’d them and the CDC has recommended how to use them.

In a letter sent Thursday and obtained by CNN, the CDC said the Biden administration has been making preparations to begin a Covid-19 booster shot rollout as early as the week of Sept. 20, but “any implementation of booster programs should begin after FDA takes a regulatory action and ACIP and CDC make clinical recommendations for use.”

The FDA’s vaccine advisers are meeting about boosters for Pfizer’s Covid-19 vaccine today, and the CDC’s Advisory Committee on Immunization Practices is scheduled to meet about boosters on Sept. 22-23.

The Pfizer/BioNTech Covid-19 vaccine is already approved by the FDA, and third doses have already been authorized for people who are immunocompromised. 

State health officials told CNN this week there was some confusion about rolling out boosters, but health officials are already preparing to administer them to eligible people as early as next week.

1:18 p.m. ET, September 17, 2021

Biden officials say Covid-19 vaccine booster plan was rolled out for transparency and planning

From CNN’s Betsy Klein

Biden administration officials defended the controversial announcement by the White House in which it said it was preparing to roll out booster Covid-19 shots for most Americans by Sept. 20 – well ahead of any consideration by the US Food and Drug Administration and the US Centers for Disease Control and Prevention – saying they were just trying to plan ahead.

The announcement prompted a flurry of criticism from health experts, including former FDA officials, who have told CNN it was unhelpful and unseemly for the White House to make such an announcement ahead of the regulators who are tasked with such decisions.

Vaccine advisers to the FDA are meeting today to discuss the question of giving booster shots.

“Let me go back to why we made the announcement in August that we did. There were two reasons: transparency and planning,” US Surgeon General Dr. Vivek Murthy told reporters Friday.

Scientific leaders in the administration, Murthy said, “had said publicly that we were following the data closely, and if we saw a signal that indicated to us that protection was starting to wane, and that additional shots may be required, that we would be transparent and open with the public about that. That was one of the reasons we felt it was important to speak up when we saw that signal in the data.” 

“The second reason is planning, you know, if you want to roll out booster shots to the population, you can't flip a switch and make that happen overnight. There’s important planning that has to take place with localities, with state governments, with community organizations. And so we laid out an initial plan for that purpose: to allow the time that we’ve now been using for the last few weeks to do that all-important coordination so the public can be confident that, if and when boosters were required, they would be there for them,” he continued.

Murthy noted that administration officials have always been clear that the plan “would be contingent on the FDA and the CDC’s independent evaluation” and that they will follow that evaluation and the recommendations. 

White House Covid-19 response coordinator Jeff Zients suggested that the decision to announce the plan publicly was made with the hindsight from the previous administration’s handling of vaccine emergency use authorization last year.

“In December, when the vaccines were initially authorized for emergency use, there was not a strong plan in place, and we saw that there was a lag in terms of getting shots in arms. So we want to make sure we're ready, whatever decision the agencies make,” Zients said. 

As CNN’s Elizabeth Cohen has reported, Friday’s scientific back and forth is happening against the backdrop of friction between members of the FDA’s vaccines advisers and the Biden administration. Advisers to the FDA told CNN they're upset that Biden announced a booster program before government scientists reviewed the data.

1:21 p.m. ET, September 17, 2021

CDC-led study finds Moderna Covid-19 vaccine most effective, but Pfizer and J&J shots also protect well

From CNN's Maggie Fox

Moderna vaccine vials are seen at a mass Covid-19 vaccination event on September 15 in Dusun Bambu, Indonesia.
Moderna vaccine vials are seen at a mass Covid-19 vaccination event on September 15 in Dusun Bambu, Indonesia. (Algi Febri Sugita/SOPA Images/LightRocket/Getty Images)

A head-to-head study of all three authorized coronavirus vaccines in the United States finds the Moderna vaccine is slightly more effective than Pfizer’s in real-life use in keeping people out of the hospital, and Johnson & Johnson’s Janssen vaccine comes in third, but still providing 71% protection.

Pfizer’s vaccine provided 88% protection against hospitalization, and Moderna’s was 93% effective.

The US Centers for Disease Control and Prevention led a nationwide study of vaccination involving more than 3,600 adults hospitalized for Covid-19 between March and August.

“Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%),” the team wrote in the CDC’s weekly report on death and disease, the MMWR.

“Although these real-world data suggest some variation in levels of protection by vaccine, all FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization.”

They found that the biggest difference between the vaccine made by Moderna and Pfizer/BioNtech’s vaccine was driven by a decline that started about four months after people were fully vaccinated with Pfizer’s vaccine.

“Differences in vaccine effectiveness between the Moderna and Pfizer-BioNTech vaccine might be due to higher mRNA content in the Moderna vaccine, differences in timing between doses (3 weeks for Pfizer-BioNTech versus 4 weeks for Moderna), or possible differences between groups that received each vaccine that were not accounted for in the analysis,” the team wrote.

“A single dose of the Janssen viral vector vaccine had comparatively lower anti-SARS-CoV-2 antibody response and vaccine effectiveness against COVID-19 hospitalizations,” they added. “Understanding differences in vaccine effectiveness by vaccine product can guide individual choices and policy recommendations regarding vaccine boosters. All FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization.”

CDC worked with researchers across the country to study 3,689 patients at 21 hospitals in 18 states for the study. They also looked at antibodies in the blood of 100 healthy volunteers after they’d been vaccinated with one of the three available vaccines.

The news comes as vaccine advisers to the US Food and Drug Administration meet Friday to discuss whether many Americans need to start getting booster doses of coronavirus vaccine.

12:39 p.m. ET, September 17, 2021

FDA vaccine advisers reconvene for public hearing

From CNN's Jacqueline Howard

After taking a 15-minute break, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) has resumed its meeting with an open public hearing.

The hearing is scheduled for one hour.

12:33 p.m. ET, September 17, 2021

"Vaccination requirements work," White House says

From CNN’s Betsy Klein

White House Covid-19 response coordinator Jeff Zients, center, speaks at a briefing on September 17.
White House Covid-19 response coordinator Jeff Zients, center, speaks at a briefing on September 17. (White House)

The White House touted the efficacy of vaccination requirements both in increasing vaccinations and boosting economic growth Friday. 

“Vaccination requirements work. And they're good for the economy,” White House Covid-19 response coordinator Jeff Zients said. He went on to highlight a few examples, including a jump from 59% to 90% since United Airlines imposed its own mandate six weeks ago, and success in getting first shots to 89% of US active duty troops, up from 76% three weeks ago.  

The White House is still working to put the new mandates Biden announced last week into effect, and the Labor Department is still writing the rule requiring large employers to require vaccinations among employees. Many businesses have voiced support but some have been skeptical. 

“Vaccination requirements work. They get more Americans vaccinated, which is the best path out of the pandemic. Plain and simple, private and public sectors implementing vaccination requirements have seen their vaccination rates increased by double digits in just a few weeks. And early adopters of vaccination requirements from private employers to healthcare systems to the military have already reached vaccination rates of about 90%, well ahead of the deadlines they've set,” Zients said. 

He went on to tie vaccination rate increases to US economic recovery. 

“By increasing the number of workers that are vaccinated, vaccination requirements will keep workplaces safe and help curb the spread of the virus in communities. That means more Americans getting back to work. It means safer schools and healthier families. It means more consumers dining out and shopping at their local small businesses. Look, you don't have to be an economist to understand why vaccination requirements will boost more than vaccination rates. They will also boost job growth, the labor market, and the overall economy,” he continued. 

Zients also made an appeal for businesses, colleges, healthcare systems, and venues that do not yet have vaccination requirements to “step up and do your part.”

“It’s the right thing to do. You have the power to save lives and help accelerate our path out of this pandemic,” he said. 

Earlier this week, Biden hosted a group of business leaders to highlight support for his administration’s measures.