Vaccine maker Moderna has applied for emergency use authorization for its vaccine for children 6 months to 5 years old on Thursday, and Pfizer and its German partner, BioNTech, are expected to submit full data on a three-dose treatment regimen for children 6 months to 4 years old in the coming weeks.
Marks said the agency would not delay one vaccine to wait for the other. The application of each product, he said, will be reviewed when the data is ready.
“We’re not going to delay things unnecessarily here,” Marks said.
FDA officials will decide closer to meeting dates which product will be reviewed when, depending on the status of reviews, he said.
Marks’ promise to quickly process vaccine requests was partly a reaction to a recent story in Politics it says that the FDA was considering suspending the authorization of the two-dose Moderna vaccine so that it could review this product alongside the three-dose Pfizer-BioNTech vaccine.
The story suggested that regulators might be uncomfortable allowing an acceptable but less effective shot when it was possible that a stronger option was a few weeks behind schedule. Angry parents have denounced any potential delay involving the Moderna vaccine.
Marks said in the interview that if the vaccines are ready for review less than a week apart, he could present them to the agency’s vaccine advisory committee in close proximity, several days in a row. But if there is a longer lag, he will hold separate adviser meetings, he said.
Marks also said that if the companies’ data stands up to scrutiny for safety, efficacy and quality, “we expect June approvals for one or more of the pediatric vaccines.”
The FDA has come under enormous pressure to act quickly — or, at least, explain its plans — on pediatric vaccines.
Parents, pediatricians and politicians have expressed growing frustration that children under 5 aren’t eligible for vaccines, long after other Americans have received vaccines and, in many cases, booster doses. . Many people have given up on masks and other protections and are trying to return to a pre-pandemic lifestyle, raising concerns for unprotected unvaccinated children.
In a statement Friday, the FDA said it understood the urgency of getting younger Americans vaccinated, but added that vaccine makers’ submissions are not “fully complete.” The agency said by reviewing the companies’ incoming data, it would provide details of the meetings and take action quickly, assuming the information supports “a clear path” to clearance.
Marks said vaccine reviews could take a few weeks longer than previous emergency vaccine authorizations due to the added complexity of variants and the need to closely examine the safety profile. Vaccine-induced fevers in young children can be more severe than in adults, he noted, causing febrile seizures.
Jeremy S. Faust, an emergency physician at Brigham and Women’s Hospital in Boston and parent of a child in this age group, said the timeline should be faster than the FDA expected, more in line with the review. of the Pfizer vaccine for 5 to 11 years, which taken less more than a month.
“I agree that the FDA needs to assess the side effect profile. It would take me about six minutes. I wouldn’t need six weeks. Just show me the data,” Faust said.
The FDA also announced its intention to meet on June 7 with its external advisers – the Advisory Committee on Vaccines and Related Biologics – to discuss an emergency authorization request for a coronavirus vaccine manufactured by Novavax for people aged 18 and over. A vocal group of investors and some people who say they prefer more traditional vaccine technology have been pushing for access to this vaccine for months.
Novavax filed for emergency use authorization at the end of January. The vaccine uses protein-based technology, with some novelties. Moderna and Pfizer-BioNTech’s vaccines are produced using a new messenger RNA technology.
Last June, Novavax mentioned the vaccine was 90% effective in preventing people from getting sick in a 30,000-person trial conducted when variants began to complicate the pandemic in the United States and Mexico. The firm had manufacturing issues, which delayed its vaccine.
Additionally, the FDA said it will convene an advisory committee meeting on June 28 to discuss whether the composition of coronavirus vaccines should be changed and, if so, which strains should be selected for use. used this fall. The agency and its advisers met on April 6 begin to sketch the outlines of a long-term strategy for the deployment of booster vaccines against coronavirus amid uncertainty about future variants and a rapidly closing window to prepare for a possible vaccination campaign in the fall.
Many experts say additional injections for the general population should be reformulated to keep up with the evolution of the virus, but whether, when and how to do so remains unresolved. FDA officials said a decision on the composition of a fall recall would likely be made by May or June.
The full data package for the Moderna app is expected to be filed early in the second week of May, according to a senior Biden administration official, who spoke on condition of anonymity because the official was not authorized to discuss the matter publicly.
The company is applying for the authorization of vaccines for children up to 17 years old. Children as young as 5 years old already have access to the Pfizer-BioNTech vaccine. Moderna’s pediatric vaccine program has been to the point of death for almost a year due to concerns about rare cases of heart inflammation in teenagers. Some parents have asked the agency to give priority to young children because they have no access to any protection.
The Pfizer-BioNTech vaccine for younger children was originally scheduled to roll out early this year. But in December, the company announced that its two-shot regimen, which is a lower dose than Moderna, had failed to meet the lab benchmark of achieving an immune response comparable to what had been reported in young people. adults. The company tested the effects of adding a third shot.
Frustration over the pace of the pediatric vaccine intensified this week amid fears a vaccine might not be available before the summer.
“We called the FDA and emailed and called our representatives” in Congress, said Katie Harmon, who has a 4-year-old unvaccinated daughter and belongs to a group of parents and pediatricians called Protect Their Future. “Children under 5 are left behind while others leave.”
The organization has sent a petition, signed by more than 1,600 people, to the FDA to seek authorization for a vaccine as soon as safety and efficacy are established. “The FDA must commit to reviewing each submission in a timely manner and on an independent schedule,” the petition states.
Members of Congressincluding Rep. James E. Clyburn (DS.C.), chair of the Select Subcommittee on the Coronavirus Crisis, also pushed the FDA on pediatric coronavirus vaccines.
Harmon said she would get her daughter vaccinated immediately, even if it means using a two-dose Moderna vaccine that might not be as effective as a three-dose Pfizer-BioNTech regimen.
“I think the best shots are the ones you can get right away,” Harmon said.
But Brooke Watts, who lives in Tacoma, Wash., has daughters ages 1 and 4 and said she thinks it would be good for the FDA to wait a bit longer and process both vaccines at the same time. .
She said the number of covid-19 cases in her area was quite low and her pediatrician had said the risk of her daughters developing serious illness from the coronavirus was low.