The Food and Drug Administration on Friday planned Three days of public meetings with its panel of independent vaccine experts for the end of this month as the agency prepares to make high-profile decisions on whether to approve Pfizer BioNTech emergency vaccine for children ages 5-11 and booster vaccinations for adults to be recipients of the vaccines Moderna and Johnson & Johnson.
The FDA typically makes its decisions within a few days of the advisory committee meetings where members discuss safety and efficacy data. The timing of the upcoming meetings suggests that the agency intends to decide quickly whether to approve both the booster and child syringes.
The committee will meet on October 14th and 15th to discuss booster doses and tentatively slated to discuss Pfizer’s pediatric vaccine on October 26th, the agency said.
“It is important that as many eligible people as possible are vaccinated as soon as possible,” said Dr. Peter Marks, the agency’s lead vaccine regulator, in a statement.
He added that “the available data make it clear that protection against symptomatic Covid-19 in certain populations decreases over time, so it is important to evaluate the information on the use of booster doses in different populations”.
The decision to have the committee discuss the evidence of the Moderna and Johnson & Johnson booster two weeks prior to the Pfizer children’s vaccine appears to reflect the FDA’s priorities and data availability. However, the agency’s decisions on these emergency permits could be made in quick succession.
Pfizer and BioNTech have yet to formally request the FDA to approve the emergency use of their pediatric dose vaccine; They are expected to do so next week, according to people familiar with the companies’ plans. If regulators approve this request, it could help protect up to 28 million children and alleviate parenting anxiety across the country. Dr. Scott Gottlieb, a board member at Pfizer, said the FDA could make a decision as early as Halloween.
Children rarely get seriously ill with the coronavirus, but the Delta variant drove nearly 30,000 of them into hospitals in August. At least 125 children, ages 5-11, have died of Covid over the course of the pandemic, and nearly 1.7 million more in that age group contracted the virus.
They make up 5 percent of Covid cases and 9 percent of the country’s population, according to the Centers for Disease Control and Prevention.
Pfizer’s vaccine has already been approved for use in emergencies for children aged 12-15 and is fully approved for children aged 16 and over. Moderna has also applied for emergency clearance to offer its vaccine to teenagers, but regulators have yet to decide on that application.
The state of vaccine mandates in the United States
- Vaccination rules. On August 23, the FDA granted Pfizer-BioNTech’s coronavirus vaccine full approval for people aged 16 and over, paving the way for mandates in both the public and private sectors. Such mandates are legally permissible and have been confirmed in legal challenges.
- College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
- Schools. California has become the first state to enact a vaccine mandate for all educators and has announced that it will add the Covid-19 vaccine as a requirement for school attendance as early as next fall. Los Angeles already has a compulsory vaccination requirement for public school students aged 12 and over who will attend class in person from November 21st. New York City has introduced mandatory vaccination for teachers and staff, but due to legal challenges, it is still in effect. On September 27, a federal appeals court overturned a decision that temporarily suspended that mandate.
- Hospitals and medical centers. Many hospitals and major health systems require their employees to be vaccinated. Health worker mandates in California and New York state appear to have forced thousands of objecters to be injected.
- New York City. Evidence of vaccination from workers and customers is required for indoor dining, gyms, performances, and other indoor situations. City education staff and hospital staff also need to be vaccinated.
- At the federal level. On the 9th of September President Biden announced a vaccination mandate for the vast majority of federal employees. This mandate applies to employees of the executive branch, including the White House and all federal agencies and members of the armed forces.
- In the private sector. Mr Biden has ordered that all companies with more than 100 employees mandate vaccinations or weekly tests to drive new company vaccination policies. Some companies, such as United Airlines and Tyson Foods, had mandates prior to Mr. Biden’s announcement.
The approval of Pfizer-BioNTech’s pediatric dose depends not only on the strength of the clinical trial data, but also on whether companies can demonstrate to the FDA that they can properly manufacture a new pediatric formulation. Dr. Janet Woodcock, the acting commissioner of the FDA, said again on Friday that regulators would thoroughly review the safety and efficacy data before making a decision.
“We know from our long experience with other pediatric vaccines that children are not little adults,” she said in a statement.
However, it may turn out that deciding whether to approve the Pfizer vaccine for children is easier than the issue of booster vaccination for Moderna and Johnson & Johnson recipients.
Last month, six months after their second vaccination, the FDA approved a booster for many recipients of the Pfizer BioNTech vaccine, and the Centers for Disease Control and Prevention recommended its use. However, these measures were followed by strenuous meetings of the advisory committees of both agencies. In the end, the government decided to offer a third vaccination only to those aged 65 and over and to those living in long-term care facilities. It also offers booster injections to adults with pre-existing medical conditions and those at higher risk of exposure to the virus because of their work or institutional setting – a broad category that includes healthcare workers and prisoners.
In addition to deciding whether to allow booster vaccinations for Moderna and Johnson & Johnson recipients, the FDA is also considering whether to allow people to receive a booster of a vaccine other than the one originally received. Researchers at the National Institutes of Health conducted a mix-and-match study to answer this question.
Separately, on Friday, the Biden government announced new details on a rule it announced last month that federal employees must be vaccinated against the coronavirus. The administration said in a memo that authorities could start enforcing this requirement on Nov. 9.