The Food and Drug Administration plans to approve a new COVID-19 booster shot this week before the vaccine is tested in humans. wall street journal.
The new booster resembles the COVID vaccine currently available in the US, with minor modifications to protect recipients from the latest version of Omicron variants.
Instead of waiting for data from human trials, the agency will combine data from mouse trials and real-world evidence of the safety of currently available COVID vaccines with previous boosters targeting older strains. Using test results from replicates to evaluate the latest boosters, FDA Commissioner Dr. Robert Calif said.
“Real-world evidence from the current mRNA COVID-19 vaccine administered to millions of individuals shows that the vaccine is safe,” Caliph said on Twitter. As we know from, the strain can be changed without affecting safety.”
He added that modifying existing vaccines to include protection against different strains of the virus does not require changing ingredients and is a common practice the FDA does with influenza vaccines.
“The FDA has extensive experience reviewing strain changes in vaccines, as is done with annual flu vaccines,” Califf said.
Both Moderna and Pfizer-BioNTech have submitted new COVID vaccine boosters to authorities for approval, and the FDA hopes to roll out booster campaigns this fall.
However, some health experts are wary of the decision to release the shot without human clinical trials being completed.
June, two experts wrote an editorial Don’t rush the FDA to roll out the latest shots.
“I feel sick that we are going to be doing millions, tens of millions of doses based on mouse data,” co-author Paul Offitt told the WSJ. rice field.
Offitt, an adviser to the FDA and director of the Center for Vaccine Education at Children’s Hospital of Philadelphia, said comparisons between influenza vaccination and COVID-19 vaccination are not well-founded due to differences in mutations and levels of protection. I think
Nor will the FDA convene another meeting to gather information from advisors on vaccine approval, as it has done in previous rollouts.
Caliph said at a meeting in June that advisers had already “overwhelmed” and voted to include the Omicron component in the COVID-19 booster.
“The agency is confident in the extensive discussions that took place in June,” he said.
COVID-19 vaccines currently on the market are not effective against new virus strains, including the latest Omicron variant BA.5.
Both Pfizer and Moderna say current data proves their latest shots are safe and effective, according to the journal.
According to multiple experts, the new version is only slightly modified to protect against new variants. Also, tests with previous versions of his two companies targeting previous strains were successful and proved safe.One such shot has already been approved in the UK
Moderna has already begun clinical trials of a vaccine targeting its latest subvariant, and Pfizer expects to begin trials later this month, but results will not be available before the vaccine is made available to the public. .
“If you’ve been waiting for the results of the clinical trials, thank you very much. We’ll have the results in the spring. It takes time to do clinical trials,” said William Schaffner, a professor of medicine at Vanderbilt University Medical Center. told the WSJ. “This is just an update to the previous vaccine we used.”
