In a letter Friday to Paul Chaplin, chief executive of Bayern Nordics, two senior FDA officials responded to concerns Chaplin raised earlier this week. have determined that the benefits of expanding the limited supply of the Jynneos vaccine to give individuals smaller doses outweigh the known potential risks.
The FDA letter, obtained on CNN Saturday, was signed by FDA Commissioner Dr. Robert Calif and Dr. Peter Marks, director of the FDA’s Center for Biologics and Evaluation Research.
The letter cites a 2015 clinical study co-authored by Chaplin, which states, “Individuals given the vaccine intradermally received a smaller dose (one-fifth) than those given the vaccine subcutaneously. rice field”.
“The results of this study showed that intradermal administration elicited an immune response very similar to subcutaneous (SC) administration,” the letter said. There was increased stiffness, itching and swelling, but less pain,” the letter continued, adding, “These side effects were manageable.”
The FDA also elaborated on other options the agency considered. However, according to the letter, the use of alternative vaccines to prevent monkeypox was “determined as impractical or not recommended at this time.” Specifically, the FDA-approved ACAM2000 vaccine for the prevention of smallpox “may not be suitable for currently potentially immunocompromised populations,” the letter said.
FDA has also considered the option of delaying the second dose by 3 to 6 months, rather than giving the second dose 28 days after the first dose.
However, officials ultimately concluded that there was no data to show that this method provided adequate protection, and that delaying the second dose could lead to “a false sense of security that the actual level of protection is protecting against monkeypox.” It is possible to give people Unknown and very likely inadequate,” the letter said.
The FDA’s Dr. Marks said Thursday that there are an estimated 1.6 million to 1.7 million people in the United States who would be eligible for the two-dose Jynneos vaccine. A vial has been sent to your jurisdiction.
The low-dose intradermal strategy quickly raised concerns among some public health experts, including the limited amount of research on the new method.
“This approach presents red flag after red flag and appears to be rushed forward without data on efficacy, safety, or alternative dosing strategies,” said David Harvey, executive director of the National Association of STD Directors. said in a statement this week.
Chaplin, CEO of Bavarian Nordic, also expressed concern. CNN reports that Chaplin wrote Tuesday in a letter to the caliphate and HHS secretary Xavier Becerra that “there is very limited safety data available” about the newly announced vaccination strategy. , and that they were concerned about the relatively high proportion of people participating in clinical studies. 20% — Did not get second shot.
“We have certain reservations, but we are trying to find the best way to help. [emergency use authorization] By gathering additional data and coordinating responses to assist state officials in deploying, Chaplin said, “We are investing to expand our manufacturing capacity at both BN and outside facilities and will soon More announcements are likely to be made.
Source: www.cnn.com
