Britain warns of allergic reactions to new virus vaccine
Country endures record day as Britain warns against Pfizer vaccine for people with history of ‘significant’ allergic reactions
The United States set a single day record Wednesday of more than 3,000 deaths linked to the virus, according to a Washington Post analysis. Texas, Colorado, Illinois and Pennsylvania led the way, with each state reporting more than 200 dead.
The grim milestone came as British regulators on Wednesday directed hospitals not to administer the new coronavirus vaccine to people with a history of “significant” allergic reactions after two people who got the shot had problems.
The Food and Drug Administration is moving ahead with its process to determine whether to approve the same vaccine rolled out in Britain, which is made by the pharmaceutical giant Pfizer and its German partner BioNTech, after a review confirmed that it meets the standard for emergency use.
The federal government has ordered 100 million doses of the two-dose vaccine, delivery of which can start as soon as regulators give the go-ahead.
The pandemic continues to rage, with more than 213,000 new cases reported in the United States on Wednesday. Pennsylvania Gov. Tom Wolf, a Democrat, was the latest notable figure to announce he had tested positive for the virus and was isolating at home. Two days earlier, Wolf had said the virus was out of control in his state and warned of a “dangerous, disturbing scenario” if its spread remained unchecked.
Health and Human Services Secretary Alex Azar said he would gladly take the first dose in the United States to demonstrate its safety. Front-line health workers and residents of nursing homes are expected to be first in line for doses expected to be administered this month.
In an interview on CNN, Azar also said he has met with representatives of the incoming Biden administration, which will be responsible for the rollout of vaccines to most Americans next year.
In a briefing with reporters Wednesday, Moncef Slaoui, science adviser for the White House’s Operation Warp Speed vaccine task force, said he assumes the FDA will consider possible allergic side effects in its review of the Pfizer vaccine.
“Subjects with known severe allergic reactions should not take the vaccine until we understand exactly what happened here,” Slaoui said, referring to the adverse reactions in two British health care workers who were among the first to get the vaccine.
Meanwhile, Canada granted interim authorization to the Pfizer vaccine and planned to begin inoculations as soon as next week and Israeli Prime Minister Benjamin Netanyahu said Wednesday that he would be the first in Israel to be inoculated against the coronavirus.
Speaking from the tarmac of Ben Gurion Airport, where several thousand doses of the vaccine arrived in the first shipment to reach Israel, Netanyahu pledged to get the shot as soon as the Pfizer vaccine receives final approval by U.S. and Israeli regulators.
Netanyahu could be the first leader of a country to get a jab against the coronavirus, and his inoculation would come at a time when officials around the world are looking to boost public confidence in several such vaccines, developed on a crash basis.
Although some allergic reactions were anticipated, the temporary guidance issued in Britain came just a day after that nation launched the first mass coronavirus immunization campaign in the West.
Two staffers with Britain’s National Health Service manifested symptoms of “anaphylactoid reaction” after receiving the vaccinations at a hospital Tuesday.
NHS officials said both workers have a history of serious allergies and carry epinephrine injectors — often called EpiPens — for the emergency treatment of acute reactions, which can include rashes, low blood pressure, constricted airways and dizziness.
“Both are recovering well,” said NHS Medical Director Stephen Powis.
Health officials in Britain quickly sought to calm nerves by noting that the nurses and pharmacists who give vaccines are prepared to deal with allergic reactions and that such reactions are rare.
Typically, even for flu shots, people with a history of allergic reactions are urged to consult with their doctors before getting any vaccine.
In remarks to journalists distributed through Britain’s Science Media Center, Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, 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 percent of people had some form of allergic reaction to the vaccine in the clinical trials (although 0.5 percent also had a reaction to the placebo), Evans said.
The FDA found slightly more adverse events “potentially representing allergic reactions” in its review of the Pfizer data. There were 137 “hypersensitivity-related” reactions to the vaccine, compared with 111 such events in the placebo group.
A spokeswoman for Pfizer said the pharmaceutical giant were advised by British regulators of two “yellow card reports” associated with allergic reactions to the vaccine. Yellow cards are issued in Britain when drugs or vaccines cause side effects, which must be reported.
Still, there were concerns that the “vaccine hesitant” and those opposed to vaccines in general could focus on the negative news, undermining efforts to combat the pandemic.
A survey from the Associated Press-NORC Center for Public Affairs Research shows about a quarter of U.S. adults aren’t sure if they want to get vaccinated against the coronavirus. Roughly another quarter say they won’t.
Many on the fence have safety concerns and want to watch how the initial rollout fares — skepticism that could hinder the campaign against the scourge that has killed nearly 290,000 Americans. Experts estimate at least 70 percent of the U.S. population needs to be vaccinated to achieve herd immunity, or the point at which enough people are protected that the virus can be held in check.