What normally takes four years, the world’s desire for a COVID-19 vaccine has pushed pharmaceutical companies to develop, test, and get FDA approved products out as soon as possible.
In less than one year, The Food and Drug Administration said the first Covid-19 vaccine being considered for U.S. distribution “met the prescribed success criteria” in a clinical study, paving the way for the agency to green-light distribution as early as this weekend.
An outside panel of scientific advisers will review the FDA report Thursday, along with a companion analysis from the vaccine’s manufacturers, Pfizer Inc. and German partner BioNTech SE. A favorable recommendation from the panel is expected to be followed within a few days by the FDA granting emergency authorization for the vaccine.
The United Kingdom, which has already given the green light, began to roll out the vaccine developed by BioNTech on Tuesday.
The next day, Britain’s National Health Service (NHS) confirmed that it is deploying “resuscitation facilities” in coronavirus vaccination centers following two healthcare workers who suffered anaphylactoid reactions after receiving the vaccine on the first day of rollout.
The NHS describes anaphylaxis as a “severe and potentially life-threatening reaction to a trigger such as an allergy,” which is the result of the body’s immune system “overreacting to a trigger” such as certain types of medication.
Following the adverse reactions experienced by the two healthcare workers, the Medicines and Healthcare products Regulatory Agency (MHRA) issued “precautionary advice” which said that people who have a “history of a significant reaction” to medicines, foods, or vaccines should avoid taking the coronavirus vaccine.
The new advice went on to state: “Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”
A professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, Stephen Evans said: “Allergic reaction occurs with quite a number of vaccines, and perhaps even more frequently with drugs. So it is not unexpected.”
“The Pfizer data showed that about 0.6% of people had some form of allergic reaction in the trial on the vaccine, but about 0.5% on placebo. So there was a genuine excess of allergic reaction but this was small and the true rate is not known, and there is a lot of uncertainty around that estimate.
Professor Evans said that it would “be wise” for those who have a history of allergic relations, such as those who need to carry an autoinjector like EpiPens, to put off taking the vaccine “until the reason for the allergic reaction has been clarified.”
The British healthcare system has previously warned that women who are pregnant or are breastfeeding should avoid taking the vaccine until more information becomes available.