FDA Approves New Covid Vaccines

The Food and Drug Administration on Monday approved a reformulated coronavirus vaccine in a bid to provide increased protection ahead of cooler weather — even as the nation endures a late-summer uptick of covid-19 cases and hospitalizations.

The shots, which target an omicron subvariants and were cleared for anyone 6 months and older, are manufactured by Moderna and by Pfizer and its German partner, BioNTech. If the Centers for Disease Control and Prevention signs off Tuesday, injections could be available in pharmacies, clinics and doctor’s offices by the end of the week.

Next Step is up to the CDC

The FDA decides who can get a shot, but it’s the CDC that recommends who should get it. That question has been vigorously debated by agency officials and its outside experts in recent days.

The CDC is leaning toward a broad recommendation that covers almost all ages, mirroring the FDA approach, according to federal officials who spoke on the condition of anonymity because they were not authorized to discuss the matter publicly. But it is possible that some on the agency’s panel of outside experts, the Advisory Committee on Immunization Practices, will push for a targeted recommendation focused on those at greatest risk — older Americans or people with weakened immune systems or other illnesses. The committee is scheduled to meet Tuesday on the matter and CDC Director Mandy Cohen is expected to n September 12 to announce its recommendations, the final step in allowing the new shot to be administered.

The fall season creates the perfect conditions for viruses — like SARS-CoV-2 and the Flu — to thrive.

Updated Covid-19 boosters are needed for two fundamental reasons: The first is that the virus is continually evolving, and the second is that our immunity wanes over time. See this post

Since the pandemic first began in 2020, Covid-19 has evolved and mutated into over three dozen major strains and variants. The newer bivalent shots that arrived in 2022 protect against the original strain of Covid as well as omicron subvariants. Here are the statistics in the United States, 69.5 percent of the US population completed their initial series of Covid-19 shots, only 17 percent received the bivalent booster, meant to protect against newer variants, that was rolled out last year.

An updated booster on the way, the Centers for Disease Control and Prevention (CDC) is expected on September 12 to announce its recommendations for the new shot, which is specifically designed to target prominent variants of the omicron strain.

We will post results from this announcement. Here at Immunology Research we distill the news into a fast readable form. Polio was wiped out by 99% of the population in the US getting Polio vaccines. As always, we recommend high quality masks, social distancing and hand washing. Be smart – don’t take chances – encourage others to take the shots this fall

Immunology Research