The latest on the Covid-19 pandemic in the US

A decision Friday by the US Food and Drug Administration’s vaccine advisers to recommend emergency use authorization of a booster dose for people 65 and older and those at high risk of severe Covid-19 was “an important step forward,” the White House said.

“Today was an important step forward in providing better protection to Americans from COVID-19. We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week,”?White House spokesperson Kevin Munoz said.

Some background: The decision came after members of the FDA’s Vaccines and Related Biological Products Advisory Committee rejected a broader application to approve booster doses of Pfizer’s vaccines in everyone 16 and older six months after they are fully vaccinated. Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose.

A healthcare worker administers a Covid-19 test on August 30, in Miami, Florida.

Florida reported fewer than 100,000 new cases of Covid-19 in the past week for the first time since July 16, according to data published Friday by the Florida Department of Health.?

Florida?reported?75,906?new?Covid-19 cases over the past week, for an average of about 10,844 cases each day.

New cases per week in Florida have been declining steadily since Aug. 20, when the state hit its peak of 151,880 new cases in a week.

Over the past week,?Florida?reported a case positivity rate of?11.2%,?according the state health department’s Covid-19 Weekly Situation Report.?

According to the published data, Florida saw 384 deaths from Covid-19 in the past week.

A scene at Sound Nightclub in Los Angeles, California on June 19, following 15 months of total shutdown.

Los Angeles County will be requiring proof of Covid-19 vaccination for all customers and employees entering indoor bars, wineries, breweries, nightclubs, and lounges starting Oct. 7.?

While the new health order is strongly recommended for restaurants, it will not be required. Children under 12 are also exempt, Dr. Barbara Ferrer, L.A. County’s public health director, announced Friday at a media briefing.

Customers and employees will need to have at least one dose of the vaccine by Oct. 7 and be fully vaccinated by Nov. 4.

The new health officer order also requires vaccine verification or a negative test result within 72 hours for those attending large events with 10,000 or more attendees in venues or events that are ticketed with controlled points of entry. This includes sports and music arenas as well as theme parks and amusement parks, Ferrer said.

Ferrer said she hopes the new health officer order will motivate more people to get vaccinated.

To date, Los Angeles County reports a total of 1,440,721 coronavirus cases and at least 25,799 deaths. Among the county’s 10.3 million residents, including those who are not yet eligible for vaccine, about 58% have been fully vaccinated.

Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine six months after full vaccination in people 65 and older and those at high risk of severe Covid-19. They rejected Pfizer’s application for boosters for a wider group of people, age 16 and older.

Here’s how some of the advisers reacted:

“I am really glad that we authorized this vaccine for a third dose and I plan to go out and get my third vaccine this afternoon,” said Dr. Jay Portnoy, a professor of pediatrics at Children’s Mercy Hospital in Kansas City.

Dr. Steven Pergram, medical director for infection prevention at Seattle Cancer Care Alliance, expressed concern that the recommendation did not cover health care workers, who are at high risk of exposure to coronavirus even if they are not necessarily at high risk of severe disease.

Dr. Peter Marks, who heads FDA’s vaccine arm, said the agency can make its own decision and asked the committee members to weigh on possible changes in wording on the EUA. “We are not bound at FDA by your vote,” Marks said. “We can tweak it.”

So the committee members voted unanimously to informally advise the FDA to include health care workers or others at high risk in the EUA.

What happens next: The Advisory Committee for Immunization Practices meets next week to advise the US Centers for Disease Control and Prevention on how to apply the FDA’s eventual decision and can fine-tune the recommendation.

The CDC has?scheduled a meeting?of its vaccine advisers for Sept. 22 and 23 — and CDC must give its stamp of approval for any booster doses to be officially given.

A healthcare worker administers a third dose of the Pfizer-BioNTech Covid-19 vaccine at a senior living facility in Worcester, Pennsylvania on August 25.

Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee had rejected a broader application – to approve the use of booster doses of Pfizer’s vaccines in everyone 16 and older six months after they are fully vaccinated.

So the FDA offered a revised question to vote on.

Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose.

Remember: The meeting and vote is just the start of the process. It’s the US Centers for Disease Control and Prevention who will decide whether or not they should be used. After the FDA advisory committee makes its recommendation, the FDA makes the decision about whether to approve the booster dose.

The CDC has?scheduled a meeting?of its vaccine advisers for Sept. 22 and 23 — and CDC must give its stamp of approval for any booster doses to be officially given.

In a letter sent Thursday and obtained by CNN, the CDC urged local and state health officials to wait to administer boosters until both agencies had signed off.

Biden administration officials have previously announced a plan to begin administering booster doses to the general population during the week of Sept. 20, pending signoff from the FDA and CDC.

Where things stand now on vaccines and boosters: Third doses are already approved for certain immunocompromised people, but not for the general public.

Pfizer received full approval for its vaccine from the FDA, so the request to add a booster dose is a supplement to that approval. Pfizer — and other researchers — say their studies show people develop strong immunity after two doses of vaccine, but that levels of antibodies start to drop after a few months

The FDA noted in its briefing documents that Pfizer’s vaccine — as well as vaccines made by Moderna and Johnson & Johnson — still provide strong protection against severe disease, hospitalization and death, even if antibodies do wane over time.

CNN’s Jamie Gumbrecht and Jacqueline Howard contributed reporting to this post.?

Orange County, Florida, Mayor Jerry Demings opened a?news?conference this afternoon by acknowledging a “fairly grim milestone”?in the?state as Florida marks over 50,000 Covid-19 deaths.??

They have “seen the same trends in Orange County as well,” Demings said, with at least 372 resident deaths in August.?There have been at least 85 additional Covid-19 deaths since the last briefing this Monday alone.?

However,?Orange?County is also “seeing some very promising news,”?said the?mayor, such as the number of daily infections declining. For the 13th straight day, the number of daily cases has been under 1,000.?

In addition, Demings pointed to Advent Health transitioning to “green status” for their facilities in Central Florida, meaning they have now returned to normal operations. This is?a?direct result of the steady decrease in infections in the area?since the peak in August.?

There is also a continued increase in the number of eligible?county residents getting their vaccinations for Covid-19, the mayor said.

“As of today, 72% of eligible residents ages 12 and up have received one or more doses of the vaccine,” he said.

What the latest data shows: According to data from John Hopkins University, the five states reporting the highest numbers of total Covid-19 deaths are:

As of 3:30 p.m. ET Friday, the total US death toll from Covid-19 was 671,098.

Vaccine advisers to the US Food and Drug Administration have received a new question to consider about boosters.

The FDA has rewritten the question it is asking its advisers. Although the Pfizer vaccine has full approval, the committee will be asked to vote on an emergency use authorization or EUA for a booster.

They are being asked to vote on whether boosters should get emergency use authorization for a booster dose six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.

Members of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee have returned from their break to revise their vote on Pfizer’s application to add a booster dose of its coronavirus vaccine.

They are readying to vote on a rewritten?question they will vote on after rejecting approval of a booster dose for everyone 16 and older six months after full vaccination.

After vaccine advisers to the US Food and Drug Administration rejected Pfizer’s application to add a booster dose of its Covid-19 vaccine, several members of the committee voiced doubts that it is a good idea to start giving boosters to the entire population.

They especially expressed concern about younger adults and older teens, who may have a higher risk of a rare complication called myocarditis – an inflammation of the heart.

“Recommending a third dose for younger people is not something I would be comfortable with at this point,” said Dr. Melinda Wharton, director of immunization services at the US Centers for Disease Control and Prevention.

The committee is now discussing voting on another question limiting the approval of a booster dose to a more limited group.

A patient shows her vaccination card to receive a booster dose of the Pfizer-BioNTech Covid-19 vaccine in Southfield, Michigan on August 24.

Vaccine data published Friday by the US Centers for Disease Control and Prevention shows more than two million Americans have already taken a Covid-19 booster shot and just over half the population is fully vaccinated, 54.4%.

The data shows:

You can see more of the CDC’s data here.

The committee is taking a 10-minute break and will reconvene to discuss voting on another question limiting the approval of a booster dose to a more limited group – possibly people 60 or 65 and older, and those at high risk of occupational exposure.

The Food and Drug Administration headquarters in Silver Spring, Maryland.

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.

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

- Source: cnn " data-fave-thumbnails="{"big": { "uri": "https://media.cnn.com/api/v1/images/stellar/prod/55200c5d-03cb-4c60-84ab-98881fb8e207.png?c=16x9&q=h_540,w_960,c_fill" }, "small": { "uri": "https://media.cnn.com/api/v1/images/stellar/prod/55200c5d-03cb-4c60-84ab-98881fb8e207.png?c=16x9&q=h_540,w_960,c_fill" } }" data-vr-video="false" data-show-html="" data-byline-html="" data-timestamp-html="" data-check-event-based-preview="" data-is-vertical-video-embed="false" data-network-id="" data-publish-date="2021-09-17T20:13:24.260Z" data-video-section="" data-canonical-url="" data-branding-key="" data-video-slug="sanjay" data-first-publish-slug="sanjay" data-video-tags="" data-details="">

Video Ad Feedback

aeaa479b-3faa-4ed6-888d-00f7ee98adec.mp4

04:07 - Source: cnn

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.

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.

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.

A senior living facility in Worcester, Pennsylvania, administers a third Covid-19 vaccine dose to its residents on August 25.

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.

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.

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.”?

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.

Moderna vaccine vials are seen at a mass Covid-19 vaccination event on September 15 in Dusun Bambu, Indonesia.

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.

“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.

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.

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

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.?

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.?

The?Food and Drug Administration’s?Vaccines and Related Biological Products Advisory Committee (VRBPAC) is taking a break until the open public hearing portion of the meeting, which begins at 12:30 p.m. ET.

The committee started meeting Friday morning to discuss whether many Americans need to start getting booster doses of coronavirus vaccine.

The meeting has been packed with presentations, including from Pfizer/BioNTech, which is arguing that there’s enough evidence of waning immunity to justify giving booster doses to people. The FDA will present its own take on the data that’s been sent to the agency so far — although written briefing materials published before the meeting suggest the agency is remaining neutral for the time being.

The meeting, which will?be streamed online, is expected to last until 4:45 p.m. ET or later, with a period for discussion and vote scheduled to start at 2:25 p.m. ET and to last at least two hours.

Covid-19 booster doses appear to have no additional adverse events or safety concerns compared with the first and second doses of vaccine, according to data from Israel.

The committee is meeting?to discuss Pfizer/BioNTech’s application for the administration of a booster dose of its Covid-19 vaccine in the United States.

Among more than 2.8 million booster doses administered in Israel, there were 1,328 non-serious adverse events reported and only 19 serious reports following that third dose, according to the safety data that Elroy-Preiss presented in Friday’s meeting.

Seven of the serious adverse events were in people ages 12 to 64. Two were allergic reactions. There was one case of myocarditis that is still under investigation and a case of Guillain-Barré syndrome that could be possibly associated with the vaccine.

The other events, which included blood clots, had no causality connected to the vaccine, according to the data. The remaining serious reports were in people ages 65 and older and included encephalitis and hemorrhage with possible connections to the vaccine. The rest of the serious events had no causality tied to the vaccine, the data showed.

Overall, “if we look at local adverse events, we would still see sort of the same trend. We don’t see any new adverse events. We know that there’s more?lymphadenopathy, but we’re not seeing any new adverse events and the rate is smaller,” Elroy-Preiss said, adding that she is presenting the data with caution. Lymphadenopathy is swollen lymph nodes.

She noted that the risk of myocarditis — inflammation of the heart — is small, and far higher from coronavirus itself than from the vaccine. Almost all the vaccine-linked myocarditis cases in Israel were not severe, she said.

Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, attends a conference in Geneva, Switzerland, on September 13.

WHO Director-General Tedros Adhanom Ghebreyesus?reiterated his call?last week for wealthy nations to refrain from boosting their Covid-19 vaccinations until shots are available to more of the world.

In a media briefing on Sept. 8, he urged countries to wait until at least the end of the year – a longer timeline than WHO’s initial call to wait till the end of September.

“A month ago, I called for a global moratorium on booster doses at least until the end of September, to prioritize vaccinating the most at-risk people around the world who are yet to receive their first dose. There has been little change in the global situation since then, so today I am calling for an extension of the moratorium until at least the end of the year, to enable every country to vaccinate at least 40% of its population,” Tedros said.

“Low and lower-middle income countries are not the second or third priority. Their health workers, older people, and other at risk groups have the same right to be protected,” he continued said.

“As the world’s largest producers, consumers and donors of vaccines, the world’s 20 leading economies hold the key to vaccine equity and ending the pandemic. Now is the time for true leadership, not empty promises,” Tedros said.

White House press secretary Jen Psaki has?reiterated the Biden administration’s view?that the US can offer Covid-19 booster shots to Americans this fall while at the same time working to provide vaccines to people around the world who have not yet received a shot.

“Our view is that this is a false choice,” Psaki told reporters at a White House briefing last week. “And the United States has donated and shared about 140 million doses with over 90 countries – more than all other countries combined.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a hearing in Washington, DC, on May 11.

Data shared ahead of key Covid-19 vaccine booster decisions supports moving forward with an additional dose of a Covid-19 vaccine for many people, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Friday.?

“Are you expecting Pfizer booster shots to be approved?” MSNBC’s Craig Melvin asked Fauci.

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is meeting Friday to review data on a potential third dose of Pfizer/BioNTech’s Covid-19 vaccine.

“The FDA, with their advisory group, the VRBPAC, will very carefully look at every single piece of data and make that determination. So, you know, rather than get ahead of them, our position about at least planning for the evaluation that we might have to give boosters we certainly have planned and are ready to go pending the decision that’s made from a regulatory standpoint, by the FDA and their advisers,” Fauci said.?

Pfizer’s top vaccine official made the company’s case for adding booster doses of Covid-19 vaccines to the US dosing schedule, saying several different lines of evidence show that people’s immunity starts to wane several months after they first get fully vaccinated.

Vaccine advisers to the US Food and Drug Administration are meeting to decide on whether to recommend adding a third dose, and if so, to whom and when.

Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said several studies indicate that people’s immunity can and does wane and that giving booster doses restores that immunity – sometimes to levels higher than seen at initial vaccination. He said people who got the boosters did not have any more side effects than seen after the first two doses.

“We’re seeing a robust immune response that equals or greatly exceeds the response that we’ve seen after the second dose,” Gruber told the meeting?

And Gruber said while the Pfizer vaccine continues to protect well against severe infection, hospitalizations and deaths, there are hints that could change. The company is relying heavily on data from Israel, where vaccinated people started to get breakthrough infections. Israeli researchers earlier told the meeting that adding booster shots in Israel helped keep many people out of the hospital.?

“In addition, recent US CDC data hint at reduced Covid-19 vaccine effectiveness over time against severe disease and hospitalization in the US,” he added. “This reduced vaccine effectiveness tracks with longer spans of time between two doses of vaccine and SARS coronavirus exposure.”

Dr. Sharon Elroy-Preiss, director of public health services at Israel's Ministry of Health, presents data during the US Food and Drug Administration's?Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on September 17.

A model projects that without booster shots – or if boosters were administered a few weeks later– Covid-19 hospitalizations in Israel could have exceeded the nation’s capacity, according to data that Dr. Sharon Elroy-Preiss, director of public health services at Israel’s Ministry of Health, presented to the US Food and Drug Administration’s?Vaccines and Related Biological Products Advisory Committee (VRBPAC)?on Friday.

“If we had not started booster doses at the end of July, we would have come to the capacity of Israel’s hospitalization capabilities, and probably would have gone beyond it,” Elroy-Preiss told VRBPAC members. The committee is meeting?to discuss Pfizer/BioNTech’s application for the administration of a booster dose of its Covid-19 vaccine in the United States.

For Israel, the modeling data suggests that with no booster doses, more than 2,000 severely ill Covid-19 patients could have been hospitalized by early September.?

The data from Israel shows that a booster dose is associated with about a 10-fold improved protection against confirmed Covid-19 infection and severe disease. The efficacy of a booster dose against the Delta coronavirus variant appears to be similar to the vaccine’s efficacy against the Alpha variant, according to the?data, and third doses were not associated with any more acute adverse events or safety concerns than first or second doses.

Vials of the Pfizer/BioNTech Covid-19 vaccine are on a table in Providence, Rhode Island, on August 5.

Vaccine advisers to the US Food and Drug Administration are meeting today to discuss whether Americans need booster shots yet.

It’s a topic that has become bogged down in?politics and turf battles.?It’s sometimes seemed to put the FDA’s independence at odds with a White House team?eager to appear to be out?ahead of an unpredictable pandemic.

On the surface, it’s a routine consideration of one company’s request for permission to start giving people a third, booster shot of its vaccine to help improve protection.

Underneath, it’s a decision that will affect all three vaccines authorized for the US market, and more that are in the pipeline. It could affect how people view vaccines, and for many, it taps into fears about disease and unknown risks.

But the questions the FDA’s Vaccine and Related Biological Products Advisory Committee will be considering are straightforward: Is immunity waning, and?will boosters restore it?

Researchers have been busy answering the second question first. Multiple studies now show that a third dose of Pfizer’s or Moderna’s vaccines, or a second dose of Johnson & Johnson’s vaccine, turbo-charge the production of antibodies.

Levels of these immune system proteins — the first line of defense against infection — spike after people get a booster dose. As with other vaccines that require boosters, a longer interval of time between initial immunization and the booster seems to amplify this response.

Some initial data from Israel also indicates this boost in antibodies does translate into fewer infections among vaccinated people. It’s this data that has helped drive the enthusiasm of White House advisers, including National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.

The second question is a little harder to answer.?Is immunity waning??Are fully vaccinated people becoming, with each day, more likely to become infected?

Again, data from Israel indicated that the longer out people were from their first round of immunizations, the more likely they were to suffer breakthrough infections.

But there is much less data about this from the United States. That’s in no small part because the US Centers for Disease Control and Prevention has not been tracking all breakthrough cases — only those serious enough to put people into the hospital or to kill them. One question VRBPAC will be asking is how much data there is indicating that immunity is starting to drop off among Americans who were among the first to be vaccinated.

Read more about today’s FDA meeting here.

US Food and Drug Administration’s Dr. Peter Marks urged the agency’s vaccine advisers to stay focused “on the science” in a committee meeting Friday to consider Covid-19 vaccine booster shots.

The?FDA’s?Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting?to discuss Pfizer/BioNTech’s application for the administration of a booster dose of its Covid-19 vaccine.

“We’re committed to focusing on the science, and we’ll drive our decision-making, and we’ll carefully consider those data in the context of the clear and obvious public health need to continue slowing the spread of Covid-19, which at this time is leading to the deaths of close to 2,000 Americans each day,” Marks said.

“As we proceed, I would ask that we do our best to focus our deliberations on the science related to the application under consideration today, and not on operational issues related to a booster campaign or on issues related to global vaccine equity. If we stray into those latter topics, the chair and I will gently bring us back into the scope of this advisory committee meeting,” he continued.

Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, said in the meeting that she looks forward to a “robust” and “evidence-based” discussion.?Gruber was one of two FDA officials who signed an opinion piece published this week in the Lancet that said current evidence do not appear to support a need for Covid-19 vaccine booster shots in the general public right now.

Gruber acknowledged that Friday’s VRBPAC meeting was likely her last, as she plans to retire next month.?

“I want to thank the American public. It has been my privilege to serve you,” Gruber said. “All of my actions and decisions over my 32-year FDA career has been grounded in science, with you in mind and in the best interest of your health and safety – and I will continue to hold fast to these principles moving forward.”

Dr. Ali Khan

Setting a timeline for Covid-19 booster doses before a full review of data was an avoidable distraction on the part of the White House, and the focus right now needs to be on people who are not yet vaccinated, University of Nebraska Medical Center College of Public Health Dean Dr. Ali Khan told CNN on Friday.

The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting Friday to review data on a potential third dose of Pfizer/BioNTech’s Covid-19 vaccine.

“We have 2,000 people dying a day currently, still about 100,000 people hospitalized. So the focus should be on the 67 million people who have not been vaccinated. They are the ones driving this pandemic, not those who have already been fully vaccinated,” he said.

Data from the US Centers for Disease Control and Prevention show just over 25% of Americans eligible to be vaccinated have not gotten a single dose yet, and more than 1.9 million Americans have received an additional dose – or booster – of a Covid-19 vaccine.

Compared to White children, kids of color in the US have borne the brunt of the Covid-19 pandemic.

These children had more cases, deaths, and have had more mental health and academic problems related to the pandemic. While the most vulnerable, they’re also less likely to be vaccinated, according to a new analysis.

The analysis published Thursday by the Kaiser Family Foundation found that the race-based disparities among children mirrored those among adults.

Compared to White children, Black, Hispanic, and Asian children were less likely to be tested for Covid-19, but were much more likely to be sick with it.

Infection rates were highest – at more than 500 cases per 10,000 children – among American Indian and Alaska Native children, Native Hawaiian and Other Pacific Islander children and Hispanic children. White and Black children had similar number of infections with about 300 cases per 10,000 people. Asian children had the lowest infection rate at a little over 200 cases per 10,000.

While Covid-19 hospitalization and death are rare among children compared to adults, those kids who were hospitalized were more likely to be Black and Hispanic. Black and Hispanic kids were also more likely to have a Covid-19 related condition called MIS-C – multisystem inflammatory syndrome in children – and Black children were more likely to be admitted to intensive care for it.

Black, Hispanic, American Indian and Alaska Native children were more likely to die from Covid-19 than White children.

More data: When it comes to school, half of the parents of Hispanic children said their children fell behind academically during the pandemic, compared to a third of White parents who said the same.

Half of Hispanic parents said their children had difficulty concentrating on their school work and also had problems eating, sleeping and had frequent stomach aches and headaches during the pandemic. About 40% of White parents said their children had the same complaints.

Researchers say there is a “dearth of data” to understand vaccination rates by race among children. From the seven states that reported this information, the vaccination rate for White children was higher than for Black children. In Connecticut and Wisconsin it was higher for White children than for Hispanic children. Vaccines are authorized for kids 12 and older in the US.

“Because children make up a significant share of the population and are more racially diverse than the rest of the population, equitable vaccination among this group is key for achieving an overall high rate of vaccine coverage among the population and may help to reduce disparities?in vaccination rates more broadly,” the report said.

Dr. Sara Oliver?with the US Centers for Disease Control and Prevention is presenting data on Covid-19 infections and the impact of the Delta variant right now in the meeting of the FDA’s?Vaccines and Related Biological Products Advisory Committee.

The committee is made up of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts.

The all-day meeting will be packed with presentations. They’ll include Pfizer/BioNTech, which is arguing that there’s enough evidence of waning immunity to justify giving booster doses to people.

The FDA will present its own take on the data that’s been sent to the agency so far — although written briefing materials published before the meeting suggest the agency is remaining neutral for the time being.

The meeting is scheduled to adjourn at 4:45 p.m. ET.

Dr. Jesse Goodman appears on CNN's New Day on September 17.

While it’s not surprising there is discussion around a booster dose of Covid-19 vaccine, it was unhelpful for the White House to announce an intention to go forward with boosters before the US Food and Drug Administration had fully reviewed available data, former FDA Chief Scientist Dr. Jesse Goodman said Friday.

“We need to have the best public discussion. And I think any number of decisions could be reasonable here, and it’s just going to be really important to explain the evidence and the decisions to the American people,” he said.

The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting today to review data on a potential third dose of Pfizer/BioNTech’s Covid-19 vaccine.

Goodman said there is some data from “short term” studies showing a third dose elicits a positive antibody response, and that additional doses in a vaccination regimen is not uncommon.

“It’s not surprising that we’re talking about boosters, because virtually every vaccine we have needs and uses a shot several months after the initial shot or shots, to sort of cement and strengthen immunity,” Goodman said.

“I just hope, because people have put some pretty strong positions out there, that everybody listens to the evidence, because we see new studies emerging every day, and makes the best possible decision,” he said.

Vaccine advisers to the US Food and Drug Administration are meeting this morning to discuss whether most Americans need to start getting booster doses of coronavirus vaccine.

The all-day meeting will be packed with presentations. They’ll include Pfizer/BioNTech, which is arguing that there’s enough evidence of waning immunity to justify giving booster doses to people.

The FDA will present its own take on the data that’s been sent to the agency so far — although written briefing materials published before the meeting suggest the agency is remaining neutral for the time being.

The Vaccines and Related Biological Products Advisory Committee is made up of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts. The group advises the FDA on vaccines, and the agency usually follows its advice.

How today’s meeting will unfold: The meeting, which will be streamed online, is expected to last until 4:45 p.m. ET or later, with a discussion and vote scheduled to start at 2:25 p.m. and to last at least two hours.

The question will be whether it’s time to start approving boosters now and if so, who should get them and when.

They’ll hear first from Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research. Another CBER official, Marion Gruber, will lay out the question at hand. It’s a routine presentation, but Gruber announced her retirement only a few weeks ago amid speculation that she was stepping down to protest White House involvement in the booster decision.

Gruber also, very unusually, signed a Lancet paper published earlier this week that argued it’s too soon to start giving people boosters.

Experts at the US Centers for Disease Control and Prevention will detail what’s known about how the Delta variant affects the rate of breakthrough infections. Researchers from the UK and Israel will present some real-world data about how many fully vaccinated people have become infected anyway, and whether giving boosters has lowered that rate of breakthroughs.

The White House has said it’s planning to be ready to start giving booster doses of vaccines Sept. 20, pending sign-off from the FDA and CDC. The CDC has scheduled a meeting of its vaccine advisers for Sept. 22 and 23 – and CDC must give its stamp of approval for any booster doses to be officially given.

Third doses are already approved for certain immunocompromised people, but not for the general public.

The current evidence on Covid-19 vaccines does not appear to support a need for booster shots in the general public right now, according to an international group of vaccine scientists, including some from the US Food and Drug Administration and the World Health Organization.

The authors of the paper include two senior FDA vaccine leaders, Dr. Philip Krause and Marion Gruber, who will be?stepping down in October and November, the FDA announced late last month. No further details were released about their retirements, although they sparked questions about whether the departures would affect the agency’s work.

The FDA and other public health agencies around the world continue to examine evidence on Covid-19 vaccine efficacy and the role booster doses of vaccine might play in improving immunity against the disease.

For the new paper in The Lancet, the scientists note that they reviewed randomized trials and observational studies on Covid-19 vaccines and consistently find that “vaccine efficacy is substantially greater against severe disease than against any infection; in addition, vaccination appears to be substantially protective against severe disease from all the main viral variants. Although the efficacy of most vaccines against symptomatic disease is somewhat less for the delta variant than for the alpha variant, there is still high vaccine efficacy against both symptomatic and severe disease due to the delta variant.”

The scientists note that there is an opportunity right now to study variant-based boosters before there could be a widespread need for them. But they also argue in their paper that the current Covid-19 vaccine supply could “save more lives” if used in people who are not yet vaccinated than if used as boosters. In early August, the World Health Organization called for a moratorium on booster shots until at least the end of September.

“To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease,” the scientists write in their paper.

The paper published just shy of a month after US federal health officials announced plans for booster doses of Covid-19 vaccine to be offered this fall, starting Sept. 20, subject to authorization from the FDA and sign off from the US Centers for Disease Control and Prevention.

It’s not clear if or when boosters doses of Covid-19 vaccines will be OK’d for fully vaccinated people in the United States, but state and local health departments across the United States are moving ahead with plans for a potential rollout next week.

Last month, US health officials announced plans for booster doses of Covid-19 vaccine to be offered starting the week of Sept. 20, subject to sign-off from the US Food and Drug Administration and the US Centers for Disease Control and Prevention.

Those conversations are getting underway this week, including a key meeting of FDA vaccine advisers on Friday, but the decision isn’t a slam dunk, experts have said.

Still, those tasked with administering boosters can’t wait for the details to be finalized.

She said that local health departments are planning now to be ready after the FDA review’s Pfizer data — especially, as they already are “really overwhelmed” right now with responding to surges of Covid-19 cases, working to get the unvaccinated vaccinated, and preparing for the flu season.

The last thing local health officials need at the moment is more chaos or confusion, but many of their questions around boosters still have not been answered: “What is the interval for boosters? Is it any shorter than eight months at this point? What is the age cut-off? Will there be priority groupings?” Freeman said. “We don’t want to appear uncoordinated on boosters.”

Read more here.

President Joe Biden delivers remarks on Covid-19 vaccines on August 18.

Dr. Paul Offit, a member of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, told CNN he thinks the decision on whether to offer Covid-19 vaccine boosters to the general public is being rushed because of a target date set by the Biden administration.

“Why did we see the New England Journal of Medicine study essentially the day before (the) meeting? I think the rush is that the date was set by the Biden administration – the Biden administration gave a date and now we’re scrambling to meet that date. I think it should have taken more time.”?

On Wednesday evening, the New England Journal of Medicine published three reports that support the argument that people may need a booster dose of Pfizer/BioNTech’s Covid-19 vaccine over time, and suggest such boosters would be safe.

Biden administration officials last month announced a plan to provide booster shots for people vaccinated against Covid-19 starting the week of Sept. 20, pending sign-off from the FDA and the US Centers for Disease Control and Prevention.

The FDA’s advisory committee meets today, and the CDC’s Advisory Committee on Immunization Practices is scheduled to meet next week.?

Three reports published Wednesday support the argument that people may need a booster dose of Pfizer’s Covid-19 vaccine over time, and suggest such boosters would be safe.

The reports are part of a batch of data that will be discussed Friday by vaccine advisers to the US Food and Drug Administration. The FDA is considering a request by Pfizer to approve a third, booster dose of its vaccine for most people six months after they get their first two doses of vaccine.

But while the FDA clearly signaled it would grant emergency use authorization to Pfizer’s and Moderna’s vaccines last December, that it would grant EUA to Johnson & Johnson’s vaccine in February and that it would fully approve Pfizer’s vaccine last month, it was notably neutral about the question of booster doses for the general public.

There are “many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” it said in a?briefing document released Wednesday?ahead of the meeting of its Vaccines and Related Biological Products Advisory Committee.

One of the reports is the?formal presentation of data?from Israel released earlier this month that showed booster doses of vaccine not only raised immunity as measured in the blood, but also showed a real-world reduction in infection.

Two others, sponsored by Pfizer, support the argument that immunity, as measured in the blood, does begin to wane over time after people get both initial doses. One shows a booster restores that immunity.

The reports, all published in the New England Journal of Medicine, are being used by Pfizer and by some federal officials to support the argument that most people will need booster doses starting around six months after they are initially vaccinated.

Read more here.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Friday will hear presentations from?FDA?vaccine experts, officials from the US Centers for Disease Control and Prevention and Pfizer, as well as Israeli researchers, ahead of a vote on whether to recommend boosters doses of Pfizer/BioNTech’s Covid-19 vaccine, according to an agenda and documents posted on Wednesday.

The committee is expected to vote after 2:25 p.m. ET Friday, according to the agenda posted Wednesday.

In a Pfizer briefing document posted on Wednesday, the company says it pursued licensure of a booster dose based on its own studies and data from Israel that suggest immunity is waning over time.

A?US Food and Drug Administration briefing document posted ahead of Friday’s FDA vaccine advisers’ meeting does not include a recommendation on whether Pfizer/BioNTech Covid-19 vaccine boosters are warranted for the general population, and says the benefit of such boosters may be “more limited” if the primary two-dose series is still effective at preventing serious outcomes from Covid-19.

The Vaccines and Related Biological Products Advisory Committee is?meeting today?to discuss “whether the data Pfizer has submitted are sufficient to support licensure of a booster dose of COMIRNATY administered approximately 6 months after the primary series to individuals 16 years of age and older,” the document says.

There are “many potentially relevant studies, but?FDA?has not independently reviewed or verified the underlying data or their conclusions,” the?FDA?document says. Some of the studies will be summarized during Friday’s?meeting, when Pfizer officials and researchers from Israel make presentations.?The document includes descriptions of research previously shared by Pfizer and Israeli researchers.

“It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability. Due to these biases some studies may be more reliable than others,” the?FDA?document says. “Furthermore, US-based studies of post- 9 authorization effectiveness of BNT162b2 may most accurately represent vaccine effectiveness in the US population.”

The document says the expected benefits of boosters depend on the impact they could have in reducing disease relative to the current two-dose series.