December 1, 2021 by John Fernandez
Roundup: Pfizer, Moderna Boosters for All Adults; Study to Review Long-Term Impact of COVID on Kids; and More
FDA, CDC Expected to Approve COVID-19 Boosters for All Adults
The U.S. Food and Drug Administration (FDA) today approved booster shots of the Pfizer-BioNTech and Moderna COVID-19 vaccines for all adults. The FDA expanded its “emergency use authorization” for the third shots, or boosters, for those who have been fully vaccinated for at least six months.
The U.S. Centers for Disease Control and Prevention (CDC) is expected to also authorize boosters for everyone 18 and older.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Janet Woodcock, M.D., said in a statement.
Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a news release that the approval helps clear up confusion as to who should get boosters. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Dr. Marks.
The FDA authorized boosters for all adults after reviewing separate clinical studies submitted by Pfizer-BioNTEch and Moderna. The studies examined levels of antibodies one month after a booster dose of the vaccine, compared to the response one month after the two-dose primary series in the same individuals.
Previously, only individuals 65 or older, or adults who are considered to be at high risk for severe disease from COVID-19 because of underlying health issues, were eligible for boosters. Additionally, those whose jobs put them at higher risk for COVID infection were also eligible.
Anyone who received the single-dose Johnson & Johnson shot can now get a booster, two months after the first shot, from any of the three vaccines. U.S. regulators have approved “mixing and matching” boosters. The booster shots from Pfizer-BioNTech and Moderna should be administered at least six months after completion of the primary series of the vaccine, the FDA and CDC said.
NIH Starts Long-Term Study of Impacts of COVID-19 on Children
The National Institutes of Health (NIH) has launched a long-term study of the impacts of COVID-19 on children and will track up to 1,000 kids and young adults who previously tested positive for the coronavirus.
The study, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), will evaluate the impact of COVID-19 on their physical and mental health over three years.
“The study is expected to yield a detailed picture of COVID-19’s effects on the overall health of children, their development and immune responses to infection, and their overall quality of life in the years following infection,” the NIH states.
Early in the COVID-19 pandemic, data suggested that children were less likely to suffer from severe cases of COVID-19 than older individuals. “However, among the 6 million reported pediatric COVID-19 cases the United States, many children have experienced significant acute and long-term effects of the disease,” the NIH states in a news release.
While increasing numbers of children are now becoming eligible to receive a COVID-19 vaccine, the lack of vaccine-derived protection has made kids especially vulnerable to infection. U.S. regulators recently approved the Pfizer-BioNTech COVID-19 vaccine for children aged 5 through 11. The vaccine has been available for individuals 12 and older for several months.
Although still rare, children can suffer from a set of inflammatory symptoms, collectively known as Multisystem Inflammatory Syndrome in Children (MIS-C), that can affect multiple organs and lead to severe illness. MIS-C can affect children who initially appeared to be asymptomatic for COVID, the NIH says.
Pfizer Says Its Anti-COVID Pill Study Showed ‘Overwhelming Efficacy” Against Severe Disease, Death
Pfizer said it has submitted a request with the U.S. Food and Drug Administration (FDA) for “emergency use authorization” of its investigational antiviral pill, Paxlovid, for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.
The submission to the FDA includes data from a clinical trial on its anti-COVID pill. “The data demonstrated an 89 percent reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with Paxlovid, compared to placebo, within three days of symptom onset, with no deaths in the treatment group,” Pfizer stated in a news release.
Pfizer added that after consulting with the FDA, it “ceased further enrollment into the study due to the overwhelming efficacy demonstrated.”
Paxlovid’s “potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” said Albert Bourla, chairman and CEO of Pfizer in a statement. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients …”