New COVID Boosters To Release Ahead Of Human Testing: Report
Aug 28, 2022 10:45 PM By Luigi Caler
www.medicaldaily.com
The upcoming COVID-19 booster shots will release even before human testing is complete. Vaccine makers are confident that they will work safely despite the earlier rollout.
The U.S. Food and Drug Administration (FDA) will authorize the new COVID booster shots this week, but The Wall Street Journal has learned that the federal agency will do so even without data from clinical trials involving humans.
According to the daily newspaper, the FDA could be bypassing its normal decision-making process in favor of the earlier release of booster shots. It wouldn’t be waiting for official data showing the shots were safe and worked in humans before giving the go signal to the rollout of the vaccines.
The upcoming boosters are mostly similar to the current COVID vaccines available in the county. Only minor modifications were made to expand their protection against the omicron variant.
Instead of waiting for human testing results, the FDA will rely on data from mice trials and real-world evidence from the currently available vaccines and test results of previous booster versions on older strains of SARS-CoV-2.
“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,” FDA Commissioner Dr. Robert Califf wrote on Twitter.
Califf also encouraged the public to get their booster shots once they become available because the COVID-19 vaccines are still “the best preventative measure” against the virus amid the pandemic.
“Vaccines are the best preventive measure against COVID-19 and its most devastating consequences. Getting vaccinated and appropriately boosted prevents death and severe illness requiring hospitalization,” he noted.
"Modifying existing vaccines to include protection against newer strains is not new. The process does not require a change in ingredient and is also commonly used with the flu vaccines,” Califf explained.
Pfizer and Moderna have submitted new COVID-19 vaccine boosters to the FDA for approval, and they are expected to roll out this fall, as per New York Post.
The vaccine makers said their current data showed that the booster shots are safe and effective against COVID-19. However, Moderna has already started human trials, while Pfizer will do the same before the month ends.
Since clinical trials take a long time, waiting for their results could push the release of the booster shots to spring, which is not very ideal considering the omicron outbreak.
Aug 28, 2022 10:45 PM By Luigi Caler
www.medicaldaily.com
The upcoming COVID-19 booster shots will release even before human testing is complete. Vaccine makers are confident that they will work safely despite the earlier rollout.
The U.S. Food and Drug Administration (FDA) will authorize the new COVID booster shots this week, but The Wall Street Journal has learned that the federal agency will do so even without data from clinical trials involving humans.
According to the daily newspaper, the FDA could be bypassing its normal decision-making process in favor of the earlier release of booster shots. It wouldn’t be waiting for official data showing the shots were safe and worked in humans before giving the go signal to the rollout of the vaccines.
The upcoming boosters are mostly similar to the current COVID vaccines available in the county. Only minor modifications were made to expand their protection against the omicron variant.
Instead of waiting for human testing results, the FDA will rely on data from mice trials and real-world evidence from the currently available vaccines and test results of previous booster versions on older strains of SARS-CoV-2.
“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,” FDA Commissioner Dr. Robert Califf wrote on Twitter.
Califf also encouraged the public to get their booster shots once they become available because the COVID-19 vaccines are still “the best preventative measure” against the virus amid the pandemic.
“Vaccines are the best preventive measure against COVID-19 and its most devastating consequences. Getting vaccinated and appropriately boosted prevents death and severe illness requiring hospitalization,” he noted.
"Modifying existing vaccines to include protection against newer strains is not new. The process does not require a change in ingredient and is also commonly used with the flu vaccines,” Califf explained.
Pfizer and Moderna have submitted new COVID-19 vaccine boosters to the FDA for approval, and they are expected to roll out this fall, as per New York Post.
The vaccine makers said their current data showed that the booster shots are safe and effective against COVID-19. However, Moderna has already started human trials, while Pfizer will do the same before the month ends.
Since clinical trials take a long time, waiting for their results could push the release of the booster shots to spring, which is not very ideal considering the omicron outbreak.
