U.S. HITS RECORD WITH 3,000 DEATHS IN SINGLE DAY
Britain halts vaccine for those with ‘significant’ allergic reactions
The United States set a single day record on Wednesday of more than 3,000 deaths linked to the virus, according to a Washing ton 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 twodose 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. Frontline 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 f lu 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.
“In the pivotal Phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee,” the company said. “The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.”
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.
Robert Wood Johnson Foundation president and CEO Richard Besser called the British development
surprising.
“I would expect that the FDA committee tomorrow is going to want to explore that more,” Besser said, adding that the FDA will have questions about what kind of allergies might be implicated.
“People are going to want to know, what does this mean for them?” Besser said.
An FDA advisory committee on vaccines meets today ahead of the agency’s decision on approval of the Pfizer-BioNTech vaccine. Approval is widely expected within days, and the first U.S. vaccinations could take place within the week.
The all-day advisory meeting includes independent experts and an opportunity for the general public to speak, which the agency regards as crucial to its effort to be transparent and convince people to take the vaccine.
Canada’s action Wednesday paves the way for the country to embark on what promises to be a logistically challenging vaccination campaign.
Prime Minister Justin Trudeau said this week that Canada could receive up to 249,000 doses of the PfizerBioNTech vaccine before the end of the year and is preparing to administer the shots at 14 sites in major cities starting as early as next week.
Canada’s deal with Pfizer includes a minimum of 20 million doses through 2021, with an option to purchase more. The first batch of vaccines could be shipped from Belgium as soon as Friday.