While the CDC undergoes changes and Dr. Anthony Fauci announced his retirement, Americans are still dealing with the COVID-19 pandemic. Within the White House, the Biden administration continues to harp on the importance of masks and the COVID-19 drug. Not to mention their efforts to gain more funding to fight the virus that has numerous variants. And now, it appears the Food and Drug Administration (FDA) is scheduled to approve a new COVID-19 booster aimed at fighting both the original strain and the Omicron variant. Although Americans have watched as both Moderna and Pfizer made billions off of a drug that didn’t stop the pandemic, it seems the new booster will be approved with human trials not being finished.
**Let’s Connect! Join Our Community**
According to a report conducted by the Wall Street Journal, the new booster will be bivalent, meaning it can fight Omicron and the original COVID-19 virus. While that might sound like progress in the fight to defeat the coronavirus, the FDA will use the data from mice to come to their decision. The Wall Street Journal wrote, “The Food and Drug Administration is expected to authorize new COVID-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.”
Issuing a statement on Twitter, FDA Commissioner Robert Califf noted that the booster will receive emergency use authorization. “FDA will rely on the totality of the available evidence in making a decision, including Clinical trial data from other bivalent mRNA COVID-19 boosters RWE from current COVID-19 vaccines administered to millions of people, non-clinical data for the bivalent BA.4/5 vaccines, bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients.”
The Commissioner suggested that the authorization of the new booster is much like the annual flu vaccine. “Real-world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe. As we know from prior experience, strain changes can be made without affecting safety.”
Back in June, two experts, John P. Moore, a virologist and professor of microbiology and immunology, and Paul A. Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, wrote an article pleading with the FDA not to authorize the drug without the full research. Offit told the Wall Street Journal, “I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data.”
Speaking on the new booster, White House COVID-19 Response Coordinator Dr. Ashish Jha suggested the booster will be ready “early to mid-September.”
Join the Discussion
COMMENTS POLICY: We have no tolerance for messages of violence, racism, vulgarity, obscenity or other such discourteous behavior. Thank you for contributing to a respectful and useful online dialogue.