U.K. allergic reactions shouldn't interfere with FDA vaccine approval

 

• The two anaphylactic allergic reactions reported by U.K. healthcare workers vaccinated against COVID-19 will likely be scrutinized by the FDA as it decides today whether to authorize Pfizer (NYSE:PFE) and BioNTech's (NASDAQ:BNTX) vaccine in the U.S., though the incident shouldn't hold up an approval.
• It's the sort of issue that the committee "deals with routinely because lots of vaccines are associated with allergic reactions in some small percentage of the population," said Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center. People with underlying health conditions aren't commonly included in clinical trials.
• The COVID-19 vaccines are "more reactogenic than the flu vaccine," added Arnold Monto, an epidemiologist at the University of Michigan who leads the panel of experts that will advise the FDA about authorizing COVID vaccines. People shouldn't be caught by surprise or dissuaded from getting the two jabs, which come spaced three or four weeks apart.
• Both NHS workers carried an EpiPen, and are recovering well, but the U.K's Medicines and Healthcare products Regulatory Agency updated its guidance to advise people who have a history of "significant" allergies to forgo the vaccine.
• Still, the reactions are why Northwell Health, which comprises 23 hospitals and nearly 800 health-care practices in NYC, Long Island and Westchester County, N.Y., plans to stagger immunizations among staffers in anticipation of any side effects that could put some out of commission for a couple of days.
• Genesis Healthcare (NYSE:GEN), the country's biggest nursing home operator, also intends to alternate staffers at each of its facilities so only one-third of them get shots on any one day, according to Richard Feifer, the company's chief medical officer.
• https://seekingalpha.com/news/3643169-u-k-allergic-reactions-shouldnt-interfere-fda-vaccine-approval