The latest on Covid-19 vaccine boosters in the US

By Melissa Macaya, Melissa Mahtani, Meg Wagner and Veronica Rocha, CNN

Updated 6:30 p.m. ET, October 15, 2021
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6:30 p.m. ET, October 15, 2021

The FDA advisers' Covid-19 boosters meeting has ended. Here's what happens next.

From CNN's Maggie Fox

Vaccine advisers to the US Food and Drug Administration voted to recommend boosters for Moderna and Johnson & Johnson’s Covid-19 vaccines over the past two days.

Here's what happened: The FDA's Vaccines and Related Biological Products Advisory Committee voted on Thursday to recommend booster doses of Moderna’s Covid-19 vaccine after six months for people over 65 and for adults with conditions putting them at risk of severe disease or whose living or work conditions put them at high risk of complications or severe disease.

The committee voted unanimously Friday to recommend booster doses of Johnson & Johnson’s Covid-19 vaccine to everyone over the age of 18 who got a dose at least two months ago. And they discussed National Institutes of Health data on mixing and matching vaccine booster doses, but didn’t vote.

What's next: The FDA will now make a decision on booster doses for Moderna’s and J&J’s vaccines based on the committee's input.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet to discuss boosters on Oct. 21.

4:11 p.m. ET, October 15, 2021

"Nobody knows" whether yearly Covid-19 booster shot will be needed, NIH director says

From CNN's Virginia Langmaid

The data isn’t available yet to know whether Covid-19 vaccines will need to be given every year, as influenza vaccines are, National Institutes of Health Director Dr. Francis Collins said Friday.

“Nobody knows. Just keep in mind of course we didn't know about this virus until 22 months ago. We are learning as we go along and we're trying to do everything we can to acquire that data,” Collins told MSNBC’s Hallie Jackson.

“But you can't speed up time unless you got a time machine. In case you do please let me know, because I'd love to have that data, too,” he said. 

“There are people who believe that the third dose in a booster situation is actually going to be really effective and really durable, and that might mean with three doses that we have immunization effectiveness for a long time. And there are other people who go, ‘Well, show me the data because maybe that one will start to wane too.’ Bottom line is, we just don't know.”

Collins said the “good news” is current vaccines are still quite effective. 

“I mean, remember where we were a year ago, where we were afraid whether we even end up with one successful vaccine? And now we have vaccines and boosters that are almost 100% effective against hospitalization and death and that's pretty amazing. So be happy about that part, even though sometimes the data seems a little complicated.”

2:26 p.m. ET, October 15, 2021

Nearly 14 million people may be eligible for a Johnson & Johnson booster shot soon

From CNN's Deidre McPhillips

If the US Food and Drug Administration follows recommendations made by its vaccine advisory panel, more than 90% of people vaccinated against Covid-19 with the Johnson & Johnson shot will be eligible for a booster shot right away.

The FDA’s vaccine advisers recommended on Friday that all adults vaccinated with the Johnson & Johnson shot receive a booster shot at least two months after their first dose. The FDA will decide whether to authorize the booster dose, and the US Centers for Disease Control and Prevention’s vaccine advisers will then be asked whether to recommend it.

To date, about 15 million people in the United States have received their first J&J shot, according to data from the US Centers for Disease Control and Prevention.

Nearly 91% of those – about 13.9 million people – received their first shot more than two months ago. Fewer than 1.4 million people have received the J&J vaccine within the past two months, CDC data shows.  

Among all vaccinated people in the US, more than 9 million have already received a booster shot. Most – about 7.8 million – were fully vaccinated with the Pfizer/BioNTech vaccine, CDC data shows. 

1:51 p.m. ET, October 15, 2021

FDA advisers vote unanimously to recommend booster doses of Johnson & Johnson's Covid-19 vaccine

From CNN's Maggie Fox

A nurse fills a syringe with Johnson & Johnson's Covid-19 vaccine at a clinic in Pasadena, California, on August 19.
A nurse fills a syringe with Johnson & Johnson's Covid-19 vaccine at a clinic in Pasadena, California, on August 19. (Robyn Beck/AFP/Getty Images)

Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend a booster dose of Johnson & Johnson’s vaccine at least two months after people get the first dose. 

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-0 to recommend the extra dose for all recipients of the J&J Janssen vaccine, 18 and older. They asked to simplify the original question being posed by the FDA, which had asked the committee to say whether the data showed that waiting six months or longer after getting the first shot would provide an even stronger immune response.

The FDA will now consider the committee’s advice. Then the US Centers for Disease Control and Prevention’s vaccine advisers will be asked to consider it.

1:33 p.m. ET, October 15, 2021

FDA vaccine advisers begin vote on question of Johnson & Johnson booster doses

From CNN's Maggie Fox

The US Food and Drug Administration's vaccine advisers are voting on the question of whether available data supports the use of a booster dose of Johnson & Johnson’s Covid-19 vaccine as an additional dose, at least two months after people get the first dose.

The FDA's committee of independent advisers typically discusses and makes recommendations to the agency around vaccine authorizations and approvals, and the agency then makes the final decision about whether to OK a vaccine.

 

 

12:14 p.m. ET, October 15, 2021

FDA vaccine advisers discuss 2 possible boost timepoints for Johnson & Johnson Covid-19 vaccine

From CNN's Maggie Fox

Vaccine advisers to the US Food and Drug Administration are being asked to suggest two possible timepoints for giving booster doses for the Johnson & Johnson’s Covid-19 vaccine. 

J&J is asking the FDA for emergency use authorization for a booster for everyone 18 and older who got its one-dose Janssen vaccine. While the company says data shows its efficacy has not waned much, it says studies show a booster dose brings protection up to levels equivalent to the 94% efficacy shown by the Moderna and Pfizer vaccines soon after they were first given in clinical trials last year.

The FDA’s Vaccines and Related Biological Products Advisory Committee is being asked to consider whether to recommend giving a Janssen booster two months after people get the first dose, six months after the first dose, or whether there might be a choice, with evidence showing that waiting six months provides a stronger response.

The FDA has been clear in telling the committee that it has been unable to verify the study data being presented by Johnson & Johnson and is, in effect, taking the company’s word for it that the vaccine’s efficacy has not waned much and that booster doses will bring immunity up to levels expected to provide protection of levels of 90% or more.

But the Johnson & Johnson vaccine has not been shown to be as protective as either the Pfizer or Moderna vaccines, noted VRBPAC chair Dr. Arnold Monto, a professor of public health and epidemiology at the University of Michigan. “So there is some urgency here to do something,” he told the meeting.

And Dr. Amanda Cohn of the US Centers for Disease Control and Prevention told the meeting that various studies suggested real-world efficacy of J&J’s vaccine was anywhere between 50% and 68%.

“Regardless of whether or not there been waning or this is the true effectiveness after a single dose, the effectiveness or protection of a single dose of the J&J vaccine is not equivalent to protection at this time with either two doses of an mRNA vaccine and certainly not in those groups who have now been authorized to receive a booster dose of an mRNA vaccine,” Cohn said.

The committee is scheduled to begin final discussion and prepare to vote on the question at around 12:45 p.m. ET.

9:36 a.m. ET, October 15, 2021

Study shows immune response stays level and low after Johnson & Johnson shot compared to other vaccines

From CNN's Maggie Fox

A pharmacist holds a vial of the Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, N.Y., on March 3, 2021.
A pharmacist holds a vial of the Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, N.Y., on March 3, 2021. (Mark Lennihan/AP)

An unusually intensive, three-way comparison of the Pfizer, Moderna and Johnson & Johnson Covid-19 vaccines shows the body’s antibody response spikes sharply and then falls off after receiving the two mRNA vaccines but stays lower and steadier after the Johnson & Johnson vaccine.

Johnson & Johnson presented the research letter, also published Friday in the New England Journal of Medicine, as part of its request to the US Food and Drug Administration for emergency use authorization for a booster dose for its one-shot vaccine.

The FDA’s vaccine advisory committee is meeting to decide whether to recommend a booster dose for J&J’s vaccine.

Researchers looked at the blood of 61 volunteers who got either Pfizer’s, Moderna’s or J&J’s vaccine, testing various immune responses two to four weeks after vaccination, at six months and at eight months. They looked at a variety of antibody responses, as well as at immune cells called T cells. 

“It’s a small study. It needs to be confirmed by larger studies, but it’s a detailed immunological analysis with lots of different types of antibody testing,” Dr. Dan Barouch, a vaccine researcher at Beth Israel Deaconess Medical Center and Harvard Medical School who led the research team, told CNN. 

Pfizer’s vaccine produced a peak antibody response at two weeks that declined sharply by six months and even more by eight months, the research team found. Moderna’s vaccine elicited a much higher neutralizing antibody response than Pfizer’s — three times as high as Pfizer’s at peak — but this also dropped dramatically by eight months.

In contrast, the J&J vaccine did not elicit a very high antibody response at first but this response also did not drop off over time. It’s not entirely clear what any of this means in terms of protecting people from infection. The study notes that it has yet to be established which types of antibody responses correlate with real-life protection from infection and severe disease. However, studies have indicated that as neutralizing antibody levels drop, protection from mild infection also drops while people remain protected from severe disease and death.

“So I think the argument for boosters are different for the mRNA vaccines and for the J&J vaccines,” Barouch said. “For the mRNA vaccines, they started off at 94, 95% efficacy and then, at least for Pfizer, we've seen that efficacy go down. And so the argument for the booster for the mRNA vaccines that antibody titers are waning quickly and at least for Pfizer, there's been an erosion of protection, seen clinically at least, at least for mild disease.” 

J&J has reported separately that boosting its one-dose vaccine brings the efficacy up from about 70% to 94%. 

“What will really change the arc of the pandemic is to get the unvaccinated people vaccinated for the first time, and that that needs to remain the priority,” Barouch said. “Discussion of boosters is good, and likely beneficial for certain individuals, but that has to be a second level priority.”

9:15 a.m. ET, October 15, 2021

Johnson & Johnson presents data on booster dose to FDA vaccine advisers

From CNN's Jacqueline Howard

A dose of the Johnson and Johnson Covid-19 vaccine is prepared at a mobile vaccination clinic at the Weingart East Los Angeles YMCA on August 7, 2021. 
A dose of the Johnson and Johnson Covid-19 vaccine is prepared at a mobile vaccination clinic at the Weingart East Los Angeles YMCA on August 7, 2021.  (Patrick T. Fallon/AFP/Getty Images)

Dr. Penny Heaton, global therapeutic area head of vaccines for Johnson & Johnson's Janssen, is presenting data on the efficacy, safety and immunogenicity of a booster dose of the company's Covid-19 vaccine to the FDA's Vaccines and Related Biological Products Advisory Committee.

"More than 14 million individuals in the US have received Janssen's vaccine and while the efficacy has been stable, it's been consistent, but we think that the data we are going to share today will highlight the opportunity we have to further increase the efficacy and the protection with a booster dose," Heaton told the advisory committee on Friday.

The presentation is scheduled for 45 minutes.

The VRBPAC meeting is scheduled to run until 5 p.m. ET. The meeting is being live streamed here.

8:55 a.m. ET, October 15, 2021

NOW: FDA vaccine advisers meet to discuss Johnson & Johnson Covid-19 boosters

From CNN's Jamie Gumbrecht

Vials of the Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, N.Y., on March 3, 2021.
Vials of the Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, N.Y., on March 3, 2021. (Mark Lennihan/AP)

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is meeting today to decide whether to recommend authorizing boosters of Johnson & Johnson’s Covid-19 vaccine for some adults.

The J&J discussion and voting period begins at 1:15 p.m. ET. 

After the J&J discussion and vote, the advisers will hear a presentation about mix-and-match vaccines, but they are not scheduled to vote on mix-and-match vaccines.

The meeting is scheduled to adjourn at 5 p.m. ET.

 The meeting is being live-streamed here.