What Happened, What You Missed: November 15-19
FDA Clears Moderna, Pfizer COVID-19 Booster Shots for All Adults On Friday, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for both the Moderna and Pfizer COVID-19 vaccines to authorize booster shots for individuals ages 18 and older at least six months after their second dose. Previously, boosters had been limited to people […]
What Happened, What You Missed: December 13-17
After Senate Hearing, Califf Poised to Lead FDA Both Republicans and Democrats serving on the Senate Health, Education, and Labor, and Pensions (HELP) Committee signaled support for Robert Califf, MD in a December 14 nomination hearing for Commissioner of the Food and Drug Administration (FDA). Ahead of the hearing, several Senators in the Democratic caucus including Bernie […]
Will COVID-19 Antiviral Pills Make a Difference?
A new era in treating COVID-19 could be upon us. On November 30, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss Merck’s request for an emergency use authorization (EUA) for Molnupiravir, an oral antiviral drug to treat COVID-19. But Molnupiravir isn’t the only oral COVID-19 antiviral in the mix – […]
What Happened, What You Missed: October 25-29
FDA Panel Recommends Pfizer Vaccine for Children Ages 5-11 On October 26, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend amending Pfizer’s Emergency Use Authorization (EUA) to allow its COVID-19 vaccine to be administered in children ages 5-11. Pfizer has reduced its vaccine dose for children under 12 […]
What Happened, What You Missed: October 18-22
FDA Authorizes Moderna, J&J Boosters, Approves Mixed Booster Regimens On October 20, the Food and Drug Administration (FDA) authorized “booster” shots for people who initially received vaccines from Moderna and Johnson & Johnson (J&J). Moderna recipients will be eligible for a third dose six months after their second shot if they’re age 65 or older, between ages […]
What Happened, What You Missed: October 11-15
Biden Likely to Nominate Califf to Lead FDA On October 14, The Washington Post first reported that former Food and Drug Administration (FDA) Commissioner Robert Califf is the Biden administration’s top pick to lead the FDA. Califf previously served as FDA Commissioner for nearly a year during the second term of the Obama administration. Despite the agency’s important […]
What Happened, What You Missed: October 4-8
Pfizer Asks FDA to Authorize Vaccine for Kids On October 7, Pfizer formally asked the Food and Drug Administration (FDA) to authorize its COVID-19 vaccine for emergency use in children aged 5-11. When approved, an estimated 28 million children in the US will be eligible for vaccines. The FDA Vaccines and Related Biological Products Advisory […]
What Happened, What You Missed: September 27-October 1
Pfizer Submits Initial Data on COVID-19 Vaccine in Kids On September 28, Pfizer submitted initial data to the Food and Drug Administration (FDA) that shows its COVID-19 vaccine generates “robust” protection in children aged 5-11. The announcement came just a week after Pfizer announced positive topline results in its clinical trials for children. Pfizer says it will formally apply […]
When Are Kids Going to Get Vaccinated?
Parents are mad. While grown-ups have been eligible for COVID-19 vaccines for almost a year, there currently aren’t any options for children under 12. This is especially concerning for many parents as the kids return to school amid a nationwide surge in cases. A Different Process On September 20, Pfizer/BioNTech released data showing its mRNA vaccine is […]
What Happened, What You Missed: September 13-17
Ahead of a September 17 meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), Food and Drug Administration (FDA) staff declined to take a position on whether to back third-dose “booster” shots of the Pfizer COVID-19 vaccine in a meeting briefing document. While FDA staff acknowledged that some observational studies have pointed to declining efficacy of the Pfizer […]