The latest on Covid-19 vaccines in the US

The US Food and Drug Administration would consider lowering the age range on its emergency use authorizations for booster shots for coronavirus vaccines once more safety data comes in, officials told reporters Wednesday.

The FDA authorized booster doses of both Moderna and Johnson & Johnson vaccines, but limited the EUA for Moderna’s vaccine to people 65 and older or those who are at least 18 and at high risk of severe Covid-19 or have frequent institutional or occupational exposure to the virus.

Dr. Peter Marks, director of the FDA's vaccine arm, the Center for Biologics Evaluation and Research, said the ability to use any authorized vaccine as a booster will simplify matters for people.

"Being able to interchange these vaccines is a good thing. It's like what we do with flu vaccines. Most people don't know what brand flu vaccine they received," Marks told reporters in a telephone briefing.

Marks said the FDA would consider lowering the age ranges for booster shots as more safety data comes in. 

"We want to make sure that if we deploy the boosters in all of the age ranges, that we truly are making a benefit outweigh any risk," Marks said. "We will not hesitate to drop this age range as we see this benefit outweigh the risk, and because of the EUA authority that we have, we can do that in a relatively quick amount of time."

 Marks said one concern was the risk of an inflammatory heart condition in young men known as myocarditis. The risk is a little higher in men who got second doses of Pfizer and Moderna vaccines. But booster doses do not seem to be associated with a higher risk of this condition, he said.

"It may be that the additional time between doses…helped reduce that risk of myocarditis,” he said.

NBA legend Kareem Abdul-Jabbar today sharply criticized seven-time All-Star Kyrie Irving for so far refusing to get a vaccine, saying he was letting down his teammates and setting a poor example for his fans. 

"I think people who are followed, who have a huge platform like that, have a responsibility greater than just the average citizen," said Abdul-Jabbar, speaking on CNN. "Young kids, especially, look up to Kyrie and are trying to model their lives after his and become great athletes."

"His stance on this is, you know, it's backwards, and he has to understand that," continued Abdul-Jabbar. "He has to be a good teammate. What he is doing is making him a bad teammate."

Irving revealed last Wednesday that he is unvaccinated a day after his team said he would not be allowed to play or practice this season until he met eligibility requirements.

The NBA had warned the Brooklyn Nets, as well as the New York Knicks and Golden State Warriors, that new Covid-19 policies set by local governments will prohibit any unvaccinated player from playing in home games in New York City and San Francisco.

Speaking on Monday, the sport's commissioner Adam Silver, told reporters he understood the vaccine mandate and urged Irving to reassess his decision.

"I think it's perfectly appropriate that New York and other cities have passed laws that require people who both work and visit arenas to be vaccinated," Silver said.

The US Food and Drug Administration authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson & Johnson Wednesday.

“We welcome the FDA’s decision to authorize emergency use of our COVID-19 vaccine as a booster,” said Paul Stoffels, M.D., vice chair of the executive committee and chief scientific officer of Johnson & Johnson.

Stoffels continued:

“Our data support a schedule that provides benefit to individuals based on their risks associated with COVID-19, whether administered as a single dose for an efficient response to the pandemic, or as a booster dose after at least two months – to protect against symptomatic COVID-19. We also welcome the FDA’s decision to include a heterologous boosting option as part of this authorization. The ability to boost immune responses regardless of the primary vaccine regimen an individual has received provides more flexibility in protecting those already immunized, and is very beneficial to global public health as we look to curb this pandemic.”

 Meanwhile, Mathai Mammen, who is the global head of Janssen research and development with Johnson & Johnson, said the authorization is "yet another positive step toward the goal of curbing the COVID-19 pandemic."

“It is now even clearer that Johnson & Johnson’s vaccine booster can play an important role in maintaining protection against COVID-19. We look forward to sharing our robust safety, efficacy and immunogenicity data in support of a booster dose with other regulatory bodies and advisory groups around the world to address the continued threat of COVID-19," Mammen added.

The US Food and Drug Administration on Wednesday authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson & Johnson.

Here's what happens next: The US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, meets tomorrow to decide on whether to recommend the FDA’s authorization for the Americans people.

Earlier today, the CDC published a final agenda for the vaccine advisory committee meeting. The panel will be discussing booster doses of Moderna and J&J vaccines, and mixing and matching of boosters. A vote is scheduled between 4:20 p.m. ET and 5 p.m. ET.

After that, the CDC director will decide whether to sign off on the advisers' guidance.

The US Food and Drug Administration authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson & Johnson Wednesday and also said any of the three authorized vaccines could be used as a booster in a “mix and match” approach.

The FDA gave emergency use authorization for boosters of Moderna’s vaccine for people fully vaccinated at least six months ago who are also at least 65, or who are at least 18 and who are high risk of severe Covid-19 or have frequent institutional or occupational exposure to Covid-19.

“The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older,” the FDA added in a statement. 

“The use of each of the available COVID-19 vaccines as a heterologous (or ‘mix and match’) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine,” the FDA said. 

“To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2,” it added.

The US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, will meet tomorrow to decide on whether to recommend the FDA’s authorization for the Americans people, and then the CDC director will decide whether to sign off on ACIP’s guidance.

New York City Mayor Bill de Blasio said during a news conference Wednesday that he does not anticipate any legal issues with the latest vaccine mandate extending to all city workers. 

“I don’t anticipate legal issues. I’ve had this conversation with our corporation counsel…many times. We have seen, uniformly, courts agree and support vaccine mandates by governments, certainly by this government,” de Blasio said.

When asked about potential staffing shortages, particularly among NYPD and FDNY members who may refuse to get vaccinated, the mayor said they “obviously have contingencies in place for any gaps that we experience” and that the city’s “uniformed agency leadership feel very strongly that they will be able to handle any scenario.” 

De Blasio continued by saying that he believes many unvaccinated city workers will decide to get vaccinated due to needing a paycheck.

“What I think is obvious after a lot of conversation with the leadership of all of our uniformed agencies, is people are there to do a job and they believe in the work. Also, they’re there for a paycheck of course…and folks are not going to give that up, by and large,” de Blasio said. “I think we’re going to see a lot of people, maybe grudgingly, but a lot of people just go and get vaccinated and continue working.”

The Biden administration “fully supports” the New York City vaccination mandate for all city workers, White House Vaccinations Coordinator Dr. Bechara Choucair said during a press conference Wednesday. 

“Today’s announcement is another important step to help get New York and the country protected, and sets an example for our country. So, we at the Biden administration fully support this action. The fact is, vaccine requirements are working,” Choucair said.

Choucair said that vaccine mandates are also good for the economy and for the labor market, particularly in getting more people back to work, “as people feel safer going back to the workplace and face fewer disruptions, including childcare.” 

There’s no evidence a new sublineage of the Delta variant is having any significant effect in the United States, US Centers for Disease Control and Prevention director Dr. Rochelle Walensky said Wednesday. 

While the AY 4.2 coronavirus subvariant has been identified in the United States, it’s not growing in frequency or causing clusters, Walensky told a White House Covid-19 briefing. 

“At this time, there is no evidence that the sublineage AY 4.2 impacts the effectiveness of our current vaccines or therapeutics,” she said.

"There are new variants that continue to emerge as cases continue to spread, and in particular, the AY 4.2 variant has drawn some attention in recent days. AY 4.2 is a sublineage of the Delta variant that has been recently identified in the UK, and we have on occasion identified this sublineage here in the United States, but not with recent increased frequency or clustering to date," Walensky said.

"CDC is continuing to track lineages and sublineages of Delta, and all other variants," Walensky said. "We particularly monitor for sublineages that could impact therapeutics, such as monoclonal antibodies and vaccines.”

 

White House Covid-19 Response Coordinator Jeff Zients outlined the administration’s plans to deploy Covid-19 vaccines for children ages 5 to 11, contingent on approval by the Food and Drug Administration and Centers for Disease Control and Prevention, including a number of operations geared specifically towards vaccinating children. 

“We expect the FDA and CDC’s decision on Pfizer’s Covid-19 vaccine for children ages 5-11 in the next couple of weeks. We know millions of parents have been waiting for Covid-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Zients told reporters during Wednesday’s Covid briefing. 

The FDA has already scheduled a meeting of its independent advisers, the Vaccines and Related Biological Products Advisory Committee or VRBPAC, for Oct. 26 to discuss the data. VRBPAC, which includes several pediatricians, will listen to what both Pfizer and the FDA have to say about what studies show and will also hear public input.

The FDA could act quickly after the VRBPAC meeting – in hours, even – and then vaccine advisers to the US Centers for Disease Control and Prevention will meet. The Advisory Committee on Immunization Practices is made up of different experts.

ACIP has scheduled a meeting for Tuesday and Wednesday Nov. 2-3 to discuss the question. The CDC Director, Dr. Rochelle Walensky, will then decide whether kids should get the vaccine based on this input.

It could take five weeks after the first dose for kids' to have full immunity:

Just as with adults, Pfizer is testing and proposing a two-dose series for kids. So that would mean two doses of vaccine given three weeks apart. And as with adults, immunity isn't immediate, even after the second dose. People have been considered fully vaccinated two weeks after the second dose and the same will go for kids.

So at the very earliest, children would be advised to continue taking precautions for five weeks after they get the first dose of vaccine. That means wearing masks, keeping a physical distance from others and avoiding crowded indoor spaces when possible.

As for boosters, it's far too soon to ask about them. It took several months of gathering real-world data before Pfizer asked FDA to authorize boosters in adults.