Letter obtained by CNN shows FDA defended new monkeypox vaccine strategy to vaccine maker

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In a letter Friday to Bavarian Nordic CEO Paul Chaplin, two top FDA officials responded to concerns expressed by Chaplin earlier this week. They wrote that the agency recently determined that the benefits of stretching the limited supply of the two-dose Jynneos vaccine by giving individuals smaller doses outweighed the known possible risks.

The decision came after the FDA ruled out — at least for now — the use of alternative vaccines, as well as the option to delay the second vaccine dose by three to six months, the agency said.

The FDA letter, obtained by CNN on Saturday, was signed by FDA Commissioner Dr. Robert Califf and Dr. Peter Marks, the director of the FDA’s Center for Biologics and Evaluation Research.

The letter cited a 2015 clinical study, co-authored by Chaplin, in which “subjects who received the vaccine intradermally received a lower volume (one-fifth) than subjects who received the vaccine subcutaneously.”

“The results of this study showed that intradermal administration produced a very similar immune response to subcutaneous (SC) administration,” the letter said. Although the intradermal injection method resulted in “more redness, firmness, itching and swelling at the injection site, but less pain,” the letter continued, “these side effects were manageable.”

The FDA also detailed other options the agency had considered. But according to the letter, using alternative vaccines to prevent monkey pox was “impractical or inadvisable at this time.” In particular, the ACAM2000 vaccine, which has been approved by the FDA for the prevention of smallpox, “may not be suitable for a potentially immunocompromised population,” the letter said.

The FDA also explored the possibility of delaying the second dose of the vaccine by three to six months, rather than giving the second dose the recommended 28 days after the first.

But the agency eventually determined that there was no data to show that this method would provide adequate protection, and that delaying the second dose could also give people “a false sense of reassurance that they were protected against monkeypox while taking the vaccine.” actual level of protection would be unknown and possibly inadequate,” the letter said.

The federal government’s announcement this week that health care providers will be authorized to give smaller doses of Jynneos came in an effort to better meet high demand for the vaccine. Health officials from Biden’s top administration have made it clear in recent days that given the rate of the spread of monkeypox – declared a public health emergency earlier this month – the US did not have enough vaccine supply to meet demand. comply. This week’s decision to expand the available Jynneos vaccines was intended to address the limited supply.

dr. Marks of the FDA said on Thursday that an estimated 1.6 million to 1.7 million people in the US are now eligible for the two-dose Jynneos vaccine. About 634,213 vials have been sent to jurisdictions as of Friday, according to the U.S. Department of Health and Human Services.

The low-dose intradermal strategy immediately raised concerns among some public health experts, including about the limited amount of research surrounding the new method.

“This approach raises red flag after red flag and appears to be moving forward without data on efficacy, safety or alternative dosing strategies,” David Harvey, executive director of the National Coalition of STDs, said in a statement this week.

Chaplin, the CEO of Bavarian Nordic, also expressed concern. CNN reported that Chaplin wrote in a letter to Califf and HHS Secretary Xavier Becerra on Tuesday that he was concerned about the “very limited safety data available” on the newly announced vaccination strategy, and that a relatively high percentage of people in the clinical trial — 20 % — didn’t get their second chance.

“Although we have certain reservations, we are trying to find the best way to [emergency use authorization] by collecting additional data and tailoring responses to assist state officials with the rollout,” Chaplin wrote. “We are also investing in expanding production capacity at both BN and outside facilities, with more announcements likely to be made soon.”

The Valley Voice
The Valley Voicehttp://thevalleyvoice.org
Christopher Brito is a social media producer and trending writer for The Valley Voice, with a focus on sports and stories related to race and culture.

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