The latest on Covid-19 vaccine boosters in the US

By Melissa Macaya, Melissa Mahtani and Meg Wagner, CNN

Updated 9:46 PM ET, Thu October 14, 2021
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4:21 p.m. ET, October 14, 2021

Vaccine advisers voted unanimously to recommend Moderna's Covid-19 booster shots. Here's what comes next. 

From CNN’s Maggie Fox

A medical staff member prepares a syringe with a vial of the Moderna Covid-19 vaccine at a pop up vaccine clinic at the Jewish Community Center on April 16, 2021 in the Staten Island borough of New York City.
A medical staff member prepares a syringe with a vial of the Moderna Covid-19 vaccine at a pop up vaccine clinic at the Jewish Community Center on April 16, 2021 in the Staten Island borough of New York City. (Angela Weiss/AFP/Getty Images)

Vaccine advisers to the US Food and Drug Administration voted unanimously Thursday to recommend emergency use authorization of a booster dose of Moderna’s Covid-19 vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee agreed use of a booster dose would be safe and effective in some people six months out from their primary series.

Moderna had asked for emergency use authorization (EUA) for a half dose of its vaccine to be used as a booster for certain people.

All 19 members of the committee supported the question:

Do available data support the safety and effectiveness of Moderna Covid-19 Vaccine for use under EUA as a booster dose (50 mcg mRNA-1273) at least six months after completion of a primary series in the following populations:

  • Individuals 65 years of age and older
  • Individuals 18 through 64 years of age at high risk of severe Covid-19, and
  • Individuals 19 through 64 years of age whose frequent institutional or occupational exposure to SARS-Covid-2 puts them at high risk of serious complications of Covid19 including severe Covid-19

What comes next: It will be up to FDA accept or reject the committee’s recommendation. Then vaccine advisers to the US Centers for Disease Control and Prevention meet Oct. 21 to decide on the recommendations.

4:36 p.m. ET, October 14, 2021

No need to expand booster recommendations to younger groups, FDA vaccine advisers say

From CNN's Maggie Fox

Vaccine advisers to the US Food and Drug Administration declined to recommend expanding recommendations for booster doses of Covid-19 vaccines, and many expressed uneasiness with having recommended boosters at all Thursday.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend half-dose booster shots for some people six months out from their first two doses of Moderna’s Covid-19 vaccine.

Their recommendation mirrors the emergency use authorization granted to Pfizer last month: people over 65 and those 18 and older at high risk of severe disease or whose work or living situation puts them at high risk of complications or severe disease. 

After the vote, members were asked to discuss whether they’d consider recommend widening that group to younger ages. Several members said they were not even fully comfortable with having recommended boosters as widely as they already had.

“I don’t agree with doing this down to 18 years of age at all,” said Dr. Paul Offit, director of the Vaccine Education Center and a pediatrics professor at Children’s Hospital of Philadelphia. 

“I am impressed by the fact that we continue to have excellent protection against moderate to severe disease in this country through Delta and for all age groups. And I just think we continue to send wrong messages out there by using terms like breakthrough and by making people feel like they’re not protected unless they’ve gotten a third dose,” he added.

“I am uncomfortable with how we just sort of tripped down the line here with the concept of a universal booster dose," he said.

Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translation Sciences at the National Institutes of Health, agreed.

“I don’t see the need for a let-it-rip campaign for boosters,” Kurilla said.

Several members noted that the real need is to get unvaccinated people in the US vaccinated for the first time, not to get booster shots into people’s arms.

“I think we heard pretty loud and clearly that there was not much appetite for moving down the age range very significantly, if at all,” said Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research. Marks said the FDA was concerned about unexpected new waves of disease.


4:16 p.m. ET, October 14, 2021

Shortage of health care workers was a factor in vaccine advisers' decision on boosters

From CNN’s Maggie Fox

Some vaccine advisers to the US Food and Drug Administration said they were not entirely convinced the data showed a booster was necessary or that it increased protection, but noted a shortage of health care workers when discussing whether to recommend emergency use authorization of a booster dose of Moderna's Covid-19 vaccine.

“The data are not perfect but these are extraordinary times and we have to work with imperfect data,” Dr. Eric Rubin, editor in chief of The New England Journal of Medicine and a professor at the Harvard TH Chan School of Public Health, said.

“We can’t afford to have health care workers, even if not sick, be positive and infected and have to stay home from work because in parts of the country there’s a shortage of health care workers and there’s burnout everywhere,” said Dr. Stanley Perlman, a professor of pediatrics at the University of California San Diego.

1:44 p.m. ET, October 14, 2021

Biden: Vaccine authorization decision for children ages 5 to 11 will happen "in the next few weeks"

From CNN's Maureen Chowdhury

President Biden said the US Food and Drug Administration and outside experts of the US Centers for Disease Control and Prevention are set to make a decision on Covid-19 vaccine authorization for children's ages 5 to 11 "in the next few weeks."

"Now I know parents out there are anxiously waiting for vaccine for children ages 5 to 11. The good news is the FDA and outside experts in the CDC are set to make its determination as to whether the vaccination will be authorized for that age range in the next few weeks," the President said in remarks from the White House.

Biden continued: "If authorized, we are ready. We have purchased enough vaccines for all children between the ages of 5 and 11 in the United States, and... it will be convenient for parents to get their children vaccinated at trusted locations, and families will be able to sleep easier at night knowing their kids are protected as well."


1:48 p.m. ET, October 14, 2021

Biden on Covid-19 response: "We're in a very critical period"

Nicholas Kamm/AFP/Getty Images
Nicholas Kamm/AFP/Getty Images

President Biden said the US is in a "critical period" in the fight against the coronavirus pandemic, stressing that while vaccine mandates are working, more Americans need to get vaccinated.

"We're in a very critical period as we work to turn the corner on Covid-19,” Biden said in White House remarks. “We have to do more to vaccinate the 66 million unvaccinated people in America. It's essential.”

The President said the Labor Department will be soon issuing "an emergency rule" for companies with 100 or more employees to implement vaccination requirements. 

Biden touted the results of the vaccine requirements implemented already by his administration, saying that "businesses and organizations that are implementing requirements are seeing their vaccination rates rise by an average of 20% or more to well over 930% of the number of employees vaccinated."

The President said vaccination requirements "should not be another issue that divides us."

"That's why we continue to battle the misinformation that's out there and companies and communities are setting up their — stepping up as well to combat these — the misinformation," he said.


1:06 p.m. ET, October 14, 2021

Biden: Final decision on Johnson & Johnson and Moderna boosters is expected in the next couple of weeks

From CNN's Aditi Sangal

The Food and Drug Administration and the Centers for Disease Control and Prevention are reviewing data on Moderna and Johnson & Johnson boosters this week, and a final decision is expected in the next couple of weeks, President Biden said.

"If they authorize the boosters, which will be strictly made based on the science, this will mean all three vaccines will be available for boosters," he told Americans.

"Already more than one out of three eligible seniors have gotten their third shot — the booster. And we're going to continue to provide that additional protection to seniors and others as we head into the holidays. These boosters are free, available and convenient to get," he added.

1:09 p.m. ET, October 14, 2021

Biden updates country on his administration's vaccination program and pandemic response

From CNN's Kate Sullivan and Betsy Klein

Nicholas Kamm/AFP/Getty Images
Nicholas Kamm/AFP/Getty Images

President Biden is delivering remarks from the White House and is expected to highlight ongoing work on Covid-19 vaccine booster shots and tout the effectiveness of vaccination requirements as he updates the public on his administration's response to the pandemic.

Biden and Vice President Kamala Harris received a briefing earlier today from members of the White House Covid-19 Response Team in the Oval Office.

The President will update the public on his national vaccination program as vaccine advisers to the US Food and Drug Administration discuss whether to authorize boosters of Moderna's coronavirus vaccine for some adults. Last month, the FDA authorized booster doses of Pfizer's vaccine for certain people.

Biden will tout his administration's response to the pandemic as cases and hospitalizations continue to decline, according to a White House official. He will stress the importance of keeping up the pressure and getting the rest of the country vaccinated, the official said.

About 188 million people, or 66.2% of the eligible US population, are fully vaccinated, according to the US Centers for Disease Control and Prevention. About 66 million people, or 23.3% of the eligible population, have not received a Covid-19 vaccine.

Some more background: Biden has touted vaccination requirements in the private and public sector as an effective way to get more people vaccinated, and has expressed frustration with the tens of millions of Americans who have not received their vaccine and are fueling the spread of the virus.

Last month, the President announced stringent new vaccine rules on federal workers, large employers and healthcare staff in an attempt to contain the latest surge of the virus. The new requirements could apply to as many as 100 million Americans, which is close to two-thirds of the American workforce.

12:11 p.m. ET, October 14, 2021

Moderna lays out how it plans to ensure potential booster dose isn't confused with larger doses

From CNN's Jacqueline Howard

Vaccine maker Moderna has a plan to help ensure that its potential 50-microgram booster shot is not mistaken for a full 100-microgram dose when being administered, a company official said on Thursday.

Currently, the initial first and second doses of Moderna's coronavirus vaccine are administered as 100-microgram doses, and in August, the US Food and Drug Administration authorized a third 100-microgram doses for certain immunocompromised people.

Now, Moderna has requested the FDA authorize a 50-microgram booster shot of its vaccine for some adults.

In a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee on Thursday, Dr. Jacqueline Miller, Moderna's therapeutic area head for infectious diseases, was asked how the company will make clear which third doses are 100 micrograms for the immunocompromised versus 50 micrograms for other people, if booster shots for more people are authorized. 

"We recognize that this will require some education and enforcement and so we are preparing to send a 'Dear Health Care Provider' letter explaining how the doses are to be administered. In addition, our fact sheet is going to contain detailed information and we have a 24-hour call center to support healthcare providers in their administration efforts," Miller told the FDA vaccine advisers on Thursday.

"The important emphasis is that the 50-microgram is a booster," Miller added. "The 100-microgram that immunocompromised subjects are receiving is really a different indication."

The vaccine doses will be packaged in multi-dose vials, Miller said.

"The current vial is a multi-dose vial. So, healthcare providers pull a 0.5ml dose, which is a 100-microgram dose, from a multi-dose vial to administer," Miller said. "That same vial can be utilized to administer a 0.25ml dose, and that 0.25ml dose being lower is actually consistent with some other vaccine — particularly during the H1N1 pandemic where lower doses of a multi-dose vial were administered to some populations."

11:43 a.m. ET, October 14, 2021

Booster shots are as safe as the initial vaccine doses, Israeli health officials tell FDA advisers

From CNN's Jacqueline Howard

Paul Ellis/AFP/Getty Images
Paul Ellis/AFP/Getty Images

Covid-19 booster doses appear to have similar side effects as the initial first and second doses — and no increased risk of allergic reaction or the heart condition myocarditis, Israeli health officials said on Thursday.

In a meeting of the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee, Dr. Sharon Alroy-Preis of Israel's Ministry of Health and Ron Milo of the Weizmann Institute in Israel presented data on the use of Covid-19 booster doses in their country, detailing safety data from the nationwide booster campaign.

Compared with first and second doses, third doses of coronavirus vaccine "have the same amount of adverse events, not more," Alroy said. "We're not seeing huge amounts of allergic adverse events post the third dose." Most people in Israel received the Pfizer vaccine.

Among 3.7 million booster doses administered, there were 2,394 reports of non-serious side effects, the data showed. 

When it comes to serious adverse events, "for 3.7 million booster doses administered, we had 44 serious adverse events reported, and for those adverse events, we have a special committee that looks into each and every case," Alroy-Preis said. 

The mRNA Covid-19 vaccines made by Pfizer and Moderna have been linked to rare cases of heart inflammation, myocarditis and pericarditis, and warnings were added to the vaccines’ fact sheets in the United States; studies have shown the cases are typically mild. 

Among 2.5 million vaccinated people, "we had nine cases of myocarditis and eight cases of perimyocarditis. So altogether, 17 cases of either myocarditis or perimyocarditis," Alroy-Preis said. "We're not seeing an increased risk of those events following the booster dose."

Overall, "the booster dose adverse events are not more acute than the first or second dose, and their rates of occurrence is not higher," Alroy-Preis said. 

"The administration of the booster dose helped Israel dampen the infections and severe cases in the fourth wave. We are now coming out of a fourth wave that, without the booster dose I believe, would have put us in a worse place with a high burden on hospitals," Alroy-Preis said. "We were able to get out of this wave due to the booster dose."