COVID-19 Vaccines Likely Will Require Annual Update Akin To Seasonal Flu Shots, FDA Leaders Say.
CNN (5/3, Howard) reports, “The United States might need to update its COVID-19 vaccines each year, according to a trio of top US Food and Drug Administration officials, and ‘a new normal’ may include an annual COVID-19 vaccine alongside a seasonal flu shot.” In an article published in JAMA Monday, FDA Commissioner Dr. Robert Califf, Principal Deputy Commissioner Dr. Janet Woodcock, and CBER Director Dr. Peter Marks wrote, “it is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal. It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates.”
Endpoints News (5/3, Brennan) reports, “COVID-19 vaccine manufacturers, the FDA, CDC, and vaccine experts will need to come together and make a decision within the next month on who should be eligible for COVID boosters next fall and what those boosters should look like,” the FDA officials added.
People Who Are Unvaccinated No Longer Account For Majority Of US COVID-19 Deaths, Data Indicate.
The Washington Post (4/29, A1, Nirappil) reported on its front page, “Unvaccinated people accounted for the overwhelming majority of deaths in the United States throughout much of the coronavirus pandemic.” However, “that has changed in recent months, according to a Washington Post analysis of state and federal data.” According to CDC data, “the vaccinated made up 42 percent of fatalities in January and February during the highly contagious Omicron variant’s surge, compared with 23 percent...in September.” The analysis “calculated the share of deaths in each age group from provisional covid-19 death records that have age details from the CDC’s National Center for Health Statistics.”
FDA To Consider Emergency Use Authorizations For Pediatric COVID-19 Vaccines In June.
The Washington Post (4/29, McGinley, Johnson) reported FDA Center for Biologics Evaluation and Research director Dr. Peter Marks “pledged Friday not to delay the rollout of coronavirus vaccines for the youngest children and said at least one of the two shots under review could become available in June.” The agency “announced plans to convene meetings with its outside advisers on June 8, 21 and 22 to consider emergency use authorizations for pediatric coronavirus shots and to hold additional sessions for other pressing vaccine matters.”
The New York Times (4/29, LaFraniere) reported that on Thursday, Moderna requested authorization of its vaccine for children under six years, and “said it would finish submitting its data to the FDA by May 9.” In the meantime, “Pfizer and BioNTech are expected to complete their application” for a three-dose regimen for “children under 5 in June.”
CBS News (4/29, Tin) reported, “Meetings of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) are now planned as many as four times in June to weigh a myriad of COVID-19 vaccine requests pending before the agency, the FDA said Friday.” Dr. Peter Marks said that “there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members. ... The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines.