With the US Food and Drug Administration’s vaccine advisory group set to discuss a vaccine for children this week, Dr. Anthony Fauci, President Biden’s chief medical adviser, said on ABC’s “This Week Sunday” he is optimistic children can get shots in the first two weeks of November.
“You never want to get ahead of the FDA in their regulatory decisions, nor do you want to get ahead of the CDC and their advisers on what the recommended would be,” Fauci told ABC News’ George Stephanopoulos. “But if you look at the data that’s been made public and announced by the company, the data looked good as to the efficacy and the safety.”
On Friday, both Pfizer and the FDA publicly released documents on the efficacy of a children’s dose of Pfizer’s Covid-19 vaccine. Company data found the vaccine was 90.7% effective against symptomatic disease in children ages 5 to 11 and the FDA said the benefits in giving the vaccine to children outweighed the risks.
The FDA independent vaccine advisory board will meet Tuesday to discuss whether Pfizer and BioNTech’s Covid-19 vaccine should be authorized for younger kids.
If authorized, it would become the first vaccine available for younger children. Pfizer’s vaccine is already authorized for children 12 to 15 and is approved for people age 16 and older.
Fauci expects the FDA to make their authorization and hand over to the US Centers for Disease Control and Prevention (CDC)’s vaccine advisory group for their recommendation on November 2 and 3. From there, the CDC director will sign off on a recommendation.
“If all goes well, and we get the regulatory approval and the recommendations from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5-11, within the first week or two of November,” said Fauci.
Pfizer to send out kids’ doses upon FDA authorization
Former FDA and Pfizer Board member Dr. Scott Gottlieb said the company will ship out doses for children as soon as the FDA signs off on it.
“If Pfizer does get the authorization on Tuesday from FDA, even before the CDC votes on is on November 2nd and 3rd, they’ll start to ship it into the supply chain,” Gottlieb said on CBS’ Face the Nation on Sunday.
“It will be available for use once there’s a hopefully positive vote from CDC. So, it could be as early as November fourth or fifth, that you can go into some locations and get your child vaccinated.”
Nearly 6.2 million children have tested positive for Covid-19 since the start of the pandemic. While cases have been trending downward recently, this past week alone about 131,000 more children were diagnosed with Covid-19, according to the American Academy of Pediatrics.
Severe illness is rare among children — they make up less than 5% of hospitalizations and less than 0.025% of deaths — but there have been 637 children who have died from Covid-19, according to the CDC. Covid-19 was among the top 10 causes of death for children 5 to 14 years of age in the first half of this year.
“Covid has not been benign among children even though they do better than older adults, we’ve had hundreds of children who have lost their lives, thousands who have been hospitalized and whose lives have been disrupted because of Covid-19,” said US Surgeon General Dr. Vivek Murthy told CNN. “We want to protect our kids. We want them to get their lives back.”
Newest Delta mutation
The country is much closer to the end of the Delta surge than the beginning, even with the newest variant mutations, Gottlieb says.
“You have seen cases come down all across the country. This new variant, we think it could be more contagious. I don’t think it’s enough to change the overall trajectory,” the former FDA commissioner told CBS’ Margaret Brennan on CBS’ Face the Nation on Sunday.
However, Gottlieb also warned while the new Delta plus variant may not significantly impact the direction of the pandemic, it may impact future vaccine formulations.
“I don’t think it will be a new variant that sweeps across the globe and we’re back to square one here,” he said. “I think this is something that will probably push in the direction of eventually reformulating our vaccines, because what we’re seeing is the new mutations are occurring with that Delta lineage.”
“I don’t think anyone should die from Covid now. This is an avoidable death,” Gottlieb added.
While some people may be immunocompromised and not mount as aggressive a response to the vaccine, they can be further protected by additional infusions of monoclonal antibody treatments used off label used to prevent infection, according to Gottlieb. They are currently authorized by the FDA to be used post-exposure but not as a prophylactic.
“The drugs can be used in that way, Regeneron is making them available under a compassionate-use basis for that use.” said Gottlieb.
Both Regeneron and Eli Lilly have authorized monoclonal antibody treatments for Covid-19. Gottlieb added Regeneron has an application for this use before the FDA.
“We should be protecting these lives,” Gottlieb said. “These are fragile lives. We have the tools to do it. We’re not making aggressive enough use of these tools.”
CNN’s Jen Christensen contributed to this report.
Children are expected to be eligible for the vaccine in early November, Dr. Anthony Fauci says
