The latest on Covid-19 and vaccine boosters

While vaccines in children aged 5 to 11 may become available by the end of October, vaccination schedules mean children in this age group won’t be fully vaccinated until December, National Institutes of Health Director Dr. Francis Collins said Thursday. 

In a discussion hosted by Bloomberg Philanthropies, Collins said data from Pfizer on its vaccine in this age group is “supposedly coming to FDA in the next week or so.”

Collins said this time frame means that other Covid-19 mitigation measures will still be important for preventing spread in schools through the fall.

“Realistically, in schools for the fall semester, we're going to have to depend on other means of mitigation. Which means the best thing you can do for those kids is actually be sure they're hanging out with other people who are immunized,” he said, naming parents, older siblings, and teachers.

Collins added: “And as unpopular as it is, wearing masks in schools, indoors, is clearly going to reduce the likelihood of outbreaks which will drive those kids back home again just when we're trying to keep them in school where they can have the benefits of that kind of learning experience.”

Data available so far indicates an additional dose of a Covid-19 vaccine can substantially reduce infection, National Institutes of Health Director Dr. Francis Collins said Thursday.

“Without dipping my hand too much, I will say the data looks really impressive, that the boosters do in fact provide substantial reduction in infection, like a tenfold reduction just within 12 days after that booster – and also a reduction in severe illness, which is the thing we're most concerned about,” Collins said in a conversation hosted by Bloomberg Philanthropies. 

Currently, the US Centers for Disease Control and Prevention’s Advisory Committee for Immunization Practices is meeting to consider the recommendation of an additional dose of Pfizer’s Covid-19 vaccine in certain groups. 

“Now we'll see whether CDC agrees with that. People may say this is a very strange and contorting process, but it’s our process, and what it does make possible is for everybody who’s interested to see the data and hear the debate in the public meeting and then understand how we came to the conclusion. I think that's a really good thing.”

The US Food and Drug Administration understands that people who got Moderna or Johnson & Johnson vaccines want to know if and when they can get booster doses, too, a top FDA official said Thursday.

The CDC’s Advisory Committee on Immunization Practices is considering how to recommend use of boosters after the FDA extended emergency use authorization to Pfizer for a third dose six months after certain people are fully immunized, including those over 65.

The EUA only covered Pfizer’s vaccine, with boosters going to those who got their first two doses of Pfizer/BioNtech vaccine at least six months ago. The FDA has not decided on Moderna’s application for booster authorization, and Johnson & Johnson has not yet applied.

Dr. Peter Marks, who heads the FDA’s vaccine branch, jumped into ACIP’s discussion Thursday.

But he said there is no precise timeline yet.

“I can tell you that we will proceed with all due urgency to try to get there as rapidly as possible working with the various vaccine sponsors,” Marks said.

Health officials in California are considering a Covid-19 vaccine requirement for students 12 and older, Gov. Gavin Newsom said Thursday.

The governor said he recognizes that a decision to require vaccines could be turbulent.

“Well we’re used to pushback, we’re the first state to do a stay-at-home order, first state to require all state employees to get vaccinated or tested as well as school employees to do the same,” he told CNN.

“We want to continue to lean in and we still have a lot of work to do,” Newsom said expressing worry about a winter surge.

“It’s back on the table to get our kids vaccinated 12 to 17. The decision will be made over the course of the next few days with a lot of partners, with 1,050 school districts in the state of California,” the governor added.

Dr. Mark Ghaly, California's Health and Human Services secretary, reiterated that "no definitive action or decision is being made at the moment.”

Ghaly said childhood immunization requirements are part of a long tradition of protection for students and generally, vaccinations are part of ongoing public health discourse.

“Certainly, the Covid vaccine as raised a number of different concerns from a number of people who have their kids fully vaccinated against a number of the other required vaccine-preventable illnesses that we see. So that said, I just want to start by reminding people that this is not something that is a new part of a conversation," Ghaly said.

Vaccine advisers to the US Centers for Disease Control and Prevention are meeting now to discuss Covid-19 booster shots. Their meeting comes a day after the US Food and Drug Administration granted emergency use authorization for a booster dose of Pfizer's vaccine for some people.

Currently, members are discussing the questions to vote on. They are considering the following policy questions:

The committee was scheduled to start voting at 3 p.m. ET and adjourn by 3:30 p.m. ET. However, the discussion is running a bit overtime. It is currently unclear when the vote will begin.

The Covid-19 vaccine booster shot is not the answer to ending the pandemic, a member of the vaccine advisory committee to the US Centers for Disease Control and Prevention said Thursday.

The CDC’s Advisory Committee on Immunization Practices is considering how to recommend use of boosters today. Their meeting comes after the US Food and Drug Administration extended emergency use authorization to Pfizer for a third dose six months after certain people are first fully immunized, including those over 65.

Some members expressed concern that focusing on boosters was causing them to miss the bigger issues.

"And I really feel like, yes, we may move the needle a little bit by giving a booster dose,” Talbot said in comments given before ACIP voted on the question.

“But the real fact of the matter is this is a pandemic of the unvaccinated,” she added. 

Some of the people at special risk of severe disease from breakthrough Covid-19 cases include cancer patients, people with chronic kidney disease, heart disease, stroke and diabetes, as well as pregnant women and smokers, the US Centers for Disease Control and Prevention said Thursday.

CDC vaccine advisers are considering how to recommend use of boosters after the US Food and Drug Administration extended emergency use authorization to Pfizer for a third dose of its Covid-19 vaccine six months after people are fully immunized.

The CDC’s Dr. Kathleen Dooling told the Advisory Committee on Immunization Practices there’s a wide variety of people who might be included in the groups named by the FDA: people over 65, those at risk of severe disease and those at high risk of infection because of their jobs. 

“Fully vaccinated persons may be at increased risk of SARS-CoV-2 infection due to occupation or setting,” Dooling added. These include essential workers and unpaid caregivers of frail or immunocompromised people, she said.

“Fully vaccinated persons with underlying medical conditions may be at risk of severe COVID-19 if they become infected with SARS-CoV-2,” she added. They include cancer stroke, chronic kidney disease, chronic obstructive pulmonary disease or COPD, diabetes, heart conditions, obesity, pregnancy and smoking.

ACIP is scheduled to vote at 3 p.m. ET.

The benefits of giving booster Covid-19 vaccine doses are much higher for people 65 and older than for younger people, according to an analysis from the US Centers for Disease Control and Prevention.

CDC vaccine advisers are considering how to recommend use of boosters after the US Food and Drug Administration extended emergency use authorization to Pfizer for a third dose six months after people are first fully immunized.

One consideration is how benefits might outweigh any risks and if so, who benefits most.

Immunizing 1 million people 65 and older would prevent 8,000 cases of Covid-19 and 2,080 hospitalizations over six months, the CDC’s Megan Wallace told the Advisory Committee on Immunization Practices. The biggest risk from vaccination with Pfizer’s vaccine is a rare heart inflammatory condition called myocarditis and just one case of myocarditis could be expected in a million people vaccinated in that age group, Wallace said.

“Even if myocarditis risk doubles – we still see more hospitalizations prevented that myocarditis cases expected,” Wallace said.

For every 1 million booster doses given, the model projects four cases of myocarditis among females and 48 among males aged 18 to 29.

A booster would prevent 9,500 cases and 114 hospitalizations among people 18-29, Wallace told the meeting. A booster would prevent:

To put it another way, she said, to prevent one hospitalization over six months, doctors would need to vaccinate 8,738 people 18-29; 3,361 people 30-49; 2,051 people 50 to 64 and 481 people 65 and older.

The CDC projection assumes a booster would raise vaccine effectiveness back up to 95%.

ACIP is scheduled to vote at 3 p.m. ET.

The goal with considering booster shots of Covid-19 vaccines is to do what’s best for the most people, US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said Thursday.

The CDC’s Advisory Committee for Immunization Practices (ACIP) is meeting to decide how best to act on the new authorization for booster shots given late Wednesday from the US Food and Drug Administration.

The FDA granted emergency use authorization to give Pfizer booster shots to people already immunized with Pfizer’s vaccine to certain people – those over 65, those at high risk of severe complications from Covid-19 breakthrough infections and those at high risk of infection because of their jobs.

ACIP is being asked to recommend how best to deploy the vaccines under the EUA. Walensky painted a picture of who might be covered under the new EUA.

“Like you, I'm approaching this decision with an interest in doing what's right for the public health,” Walensky told the ACIP members.

“And like you, I'm also thinking about the 25-year-old man with cystic fibrosis, who may walk into our clinic, nervous about his risk of for one more complication, and also of the 35-year-old pregnant resident, working in a Tennessee emergency room with a one-year-old at home.”

Walensky said many more decisions will need to be made about Covid-19 vaccines. “We all know that the pace is unlikely to let up any time soon,” she said.

Moderna has asked for authorization for boosters for people who got its vaccine, and Johnson & Johnson is preparing to make a case for boosters for its vaccine.