The manufacturer of the Jynneos monkeypox vaccine, Bavarian Nordic, voiced concerns to federal health officials about efforts to expand vaccine supplies by allowing the administration of fractional doses, The Washington Post reported Aug. 10.
The FDA on Aug. 9 issued an emergency use authorization to allow a single vial of the Jynneos vaccine to be split into up to five different doses and be administered intradermally, or between layers of skin, rather than subcutaneously, or beneath the skin. Federal health officials' decision to move forward with the approach was largely based on a single study from 2015, and has been met with mixed reactions from health experts. To read more about intradermal injections, click here.
The Post obtained a letter Bavarian Nordic's CEO, Paul Chalin, wrote to HHS Secretary Xavier Becerra following official news of the alternative dosing strategy.
"We do have some reservations … due to the very limited safety data available," Mr. Chaplin said in the letter. "It would have been prudent" for further studies to have been completed before shifting the nation's monkeypox vaccine strategy, he said, adding Bavarian Nordic has been "inundated with calls from U.S. state government officials with questions and concerns" about how to implement the plan.
Mr. Becerra acknowledged the concerns in interviews Aug. 10, the Post reports.
"We've had conversations with [Bavarian Nordic] about this, and so has the FDA," he said. "We wouldn't have moved forward unless we thought it was safe and effective, and if FDA hadn't dotted its I's and crossed its T's."
Three more updates:
1. Confirmed U.S. cases have surpassed 10,000, according to CDC data updated Aug. 10. About a month ago, there were less than 1,000 reported cases nationwide. The U.S. accounts for about 33 percent of nearly 32,000 cases worldwide. If not contained, some health officials anticipate the virus could eventually begin spreading more broadly among young people who are more likely to visit crowded bars and clubs.
2. Physicians have been surprised by the severe pain symptoms are causing some infected patients. The hospitalization and death rates for monkeypox are low, but that doesn't discount the pain people are experiencing. Jason Zucker, MD, an infectious diseases specialist at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, said there's been a "small" number of patients whose symptoms were severe enough to require hospitalization. Some patients develop urethral lesions, making it painful every time they urinate, as well as severe rectal pain and bleeding, Dr. Zucker said.
3. The World Health Organization warned against attacking animals after reports of primates being attacked and killed. "What people need to know very clearly is the transmission we are seeing is happening between humans to humans," Dr. Margaret Harris, a spokesperson for the agency, said during an Aug. 9 media briefing. "It’s close-contact transmission. So the concern should be about where it's transmitting in the human population and what humans can do to protect themselves from getting it and transmitting it. They should certainly not be attacking any animals," Dr. Harris said, adding that efforts to change the virus's name are ongoing. The warnings come after seven monkeys in Brazil died after being rescued for showing signs of intoxication or having been harmed, NBC News reported.