The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization (EUA) for their COVID-19 vaccine booster. Moderna has also submitted an EUA for its booster. For that and more COVID-19 news, read on.
Moderna Requests EUA for Boosters for All Adults
Following the lead of Pfizer and BioNTech, Moderna has submitted a request to the FDA for a third booster shot of its COVID-19 vaccine to be granted EUA for all adults, regardless of health conditions. It would be for a 50-microgram dose, half of the 100 micrograms used in the first two shots. To date, about 71 million adults in the U.S. have been vaccinated with the Moderna vaccine. The booster is already authorized for adults 65 and older and those at high risk for severe COVID-19 from underlying conditions or work or living environments. The CDC vaccine advisory committee meeting is scheduled for November 19 to discuss the Pfizer-BioNTech EUA request for all adults to be eligible for a booster.
AstraZeneca’s Antibody Therapy 83% Effective
AstraZeneca reported that its antibody treatment for COVID-19, AZD8442, was 83% effective at preventing the development of symptomatic disease. In an earlier analysis, the risk of developing a severe disease was decreased by 77%. Three-quarters, or more than 75%, of the people in the study, had underlying health conditions that placed them at high risk of severe COVID-19, including compromised immune systems.
Hugh Montgomery, professor of intensive care medicine at University College London and principal investigator in the studies, stated, “These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives.”
Mayo Clinic: Monoclonal Antibodies Effective Against Breakthrough COVID-19
A Mayo Clinical study published in the Journal of Infectious Diseases demonstrated that monoclonal antibodies decreased the risk of hospitalization from breakthrough COVID-19 cases by 77%. The study was in 1,395 patients with breakthrough infections. The research compared outcomes of confirmed COVID-19 patients who were fully vaccinated and were treated with either Eli Lilly or AbCellera Biologics’ bamalanivimab, bamlanivimab-etesivimab or Regeneron Pharmaceuticals’ casirivimab-imdevimab from January to August 16, 2021, to people who didn’t receive antibody treatment.
Antibody Protection from Mild COVID-19 Might Not Last
In a study of 43 Australians who had mild COVID-19 early in the pandemic, 90% still had antibodies against the virus a year later. However, only 51.2% had antibodies that demonstrated “neutralizing activity” against the Wuhan wildtype strain, 44.2% against the Alpha (U.K.) strain, and only 16.2% against the Delta variant. The authors conclude that people who had mild COVID-19 “are vulnerable to infection with circulating and newly emerging SARS-COV-2 variants 12 months after recovery.”
Delta Subvariant, So-Called Delta-Plus, Less Likely to Cause Symptoms
Call it a win. A study out of Imperial College London into a subvariant of the Delta variant, AY.4.2., sometimes dubbed Delta-Plus, showed the subvariant was less likely to cause symptomatic COVID-19. Although it has grown to 12% of sequenced samples in the U.K., only a third of those patients had “classic” COVID-19 symptoms compared to about half of the people with the dominant Delta variant infection. It’s possible the subvariant is more transmissible but hasn’t been shown to cause more severe disease or to evade vaccines more than Delta.
Bill Gates: COVID-19 Deaths May Drop to Seasonal Flu Levels Next Year
Speaking at a conference in Singapore, Bill Gates, Microsoft founder and co-founder of the Bill and Melinda Gates Foundation, said that due to vaccinations and new treatments, he thinks the number of COVID-19 deaths will be dropping “pretty dramatically.” He noted that more people will have natural immunity, broader vaccine distribution, and new antiviral pills. He suggested the death rate would drop to something equivalent to that of seasonal flu, which according to the World Health Organization (WHO), kills about 290,000 to 650,000 each year. So far, more than five million people have died from COVID-19 globally since late 2019.
