The following is an excerpt from The New York Post.
The Food and Drug Administration is expected to approve new Covid-19 booster shots this week — before the vaccines are tested on humans, according to a new report by the Wall Street Journal.
The new boosters are similar to the Covid vaccines currently available in the US with minor modifications that protect recipients from the latest version of the Omicron variant.
Instead of waiting for data from testing in humans, the agency will use data from trials in mice — as well as the real-world evidence of the safety of currently available Covid vaccines and test results from earlier iterations of boosters targeting older strains — to evaluate the newest boosters, FDA Commissioner Dr. Robert Califf said.
“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,” Califf said on Twitter. “As we know from prior experience, strain changes can be made without affecting safety.”
He added that modifying existing vaccines to include protection against different viral strains doesn’t require a change in ingredients and is a common practice of the FDA with flu vaccines.
However, some health experts are wary of the decision to release the shots without completed human trials.
In June, two experts penned an op-ed demanding that the FDA not rush through the rollout of the newest shots.
“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,” one of the authors, Paul Offit, told the Journal.
Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, believes the comparison between flu shots and Covid-19 shots is not well grounded due to the differences in mutations and protection levels.
Moderna has already begun human trials on the newest subvariant-targeting vaccine and Pfizer is expected to begin such tests this month, but results will not be available before the vaccines are brought to the general public.
Read full article here.
Visit the Lemonade Mermaid Store today
Original and Custom items for Land or Sea Mermaids
Bill Andrews says
Interesting ?. I also came across this Molecular Chemistry in the Universe and what potential it has for mankind ? ( C (=O)OH)H2) Heat of Fusion (H2) 0.1117 k3/Mol In Hydrogen Gas changes Benifits from the putter limits in the Universe ?
Winston Hashburn says
Big Pharm needs all the income they can generate so they can pay billions to settle out of court.
Bill Andrews says
My earlier post and Winston post I agree, what my earlier discovery Formula I posted here is because this Formula in Chemistry is like a locked Door in the Dark Universe that allowed me to find.. Now I'm going to do Molecular Formulas in a Handwritten notebook away from people that is back dooring into my devices and has been since 2001, that in Time may take me two years or more to unlock that Door to a New Treatment's for Non-Hodgkin lymphoma (NHL) = I don't want the Bad people giving my work to these people you are talking about they have enough Billions they will never use ? ( New productive Chemistry crossword puzzle Hobby to occupy Ones Mind to help Kids in the Future ? ) Time in a sphere !