Nation sees day's deaths surpass 3,000

Allergic reactions prompt British caution on vaccine

Jaqueline Koren, a registered nurse in Camden, N.J., gives a coronavirus test Wednesday to a woman at the Cooper’s Poynt School. The city has opened new testing sites because of a recent surge in coronavirus cases.
(AP/The Philadelphia Inquirer/Jose F. Moreno)
Jaqueline Koren, a registered nurse in Camden, N.J., gives a coronavirus test Wednesday to a woman at the Cooper’s Poynt School. The city has opened new testing sites because of a recent surge in coronavirus cases. (AP/The Philadelphia Inquirer/Jose F. Moreno)

The United States set a single day record on 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.

Less than half of the available 6.4 million doses of Pfizer's vaccine will be initially sent out to states, and 500,000 will be held separately in reserve by the government, according to a top official at Operation Warp Speed.

[CORONAVIRUS: Click here for our complete coverage » arkansasonline.com/coronavirus]

Gustave Perna, the army general who serves as Warp Speed's chief operating officer, said on a call with reporters Wednesday that the U.S. plans to distribute 2.9 million doses in the first round of shipments after authorization of Pfizer's still-experimental vaccine. The rest will be held back to be distributed to states and other jurisdictions when the first people vaccinated are due for their second dose 21 days later.

The half a million shots in reserve will be ready for unforeseen circumstances, Perna said, calling the move "good army general officer planning."

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 Operation Warp Speed, said he assumes the FDA will consider possible allergic side effects in its review of the Pfizer vaccine.

[Video not showing up above? Click here to watch » https://www.youtube.com/watch?v=o8WSh9vDTpw]

"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.

"This a momentous occasion," said Dr. Supriya Sharma, chief medical adviser at Health Canada. "The geek in me is amazed. No one would have thought, even when we looked back at the first discovery of the virus, that less than a year later we would be authorizing and distributing a vaccine."

Sharma said Canadians should feel comfortable getting the shot, which was "authorized only after a thorough assessment of the evidence demonstrated that it met Canada's strict standards for safety, efficacy and quality."

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.

ALLERGIC REACTIONS

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.

[EMAIL SIGNUP: Form not appearing above? Click here to subscribe to updates on the coronavirus » arkansasonline.com/coronavirus/email/]

Two staff members with Britain's National Health Service manifested symptoms of "anaphylactoid reaction" after receiving the vaccinations at a hospital Tuesday.

National Health Service 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 National Health Service 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% of people had some form of allergic reaction to the vaccine in the clinical trials, although 0.5% 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 was 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, interviewed Wednesday, 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 persuade people to take the vaccine.

CANADIAN VACCINATIONS

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 Pfizer-BioNTech 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.

Trudeau has said he hopes most Canadians are vaccinated by September.

Separately, BioNTech and Pfizer said data on their coronavirus vaccine were "unlawfully accessed" during a cyberattack on the servers of the European Medicines Agency.

The Amsterdam-based agency, which is considering requests for conditional marketing authorization for several coronavirus vaccines to be used in the 27-nation European Union, said earlier Wednesday that it had been the target of a cyberattack.

The European Medicines Agency declined to provide more details of the attack while the investigation was continuing, but the two companies later released a statement saying that "some documents relating to the regulatory submission for Pfizer and BioNTech's covid-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed."

They added that no BioNTech or Pfizer systems had been breached in connection with the incident and that they weren't aware that any study participants had been identified as a result of the data being accessed.

"At this time, we await further information about EMA's investigation and will respond appropriately and in accordance with EU law," the companies said. "EMA has assured us that the cyber attack will have no impact on the timeline for its review."

NURSING HOME PAYMENTS

In the U.S., More than 9,000 nursing homes have been able to show progress in controlling the novel coronavirus infection, according to the Department of Health and Human Services, and will share $523 million in incentive payments as a reward, starting Wednesday.

The emergency spending plan marks a departure for Medicare and Medicaid, which pay for the majority of nursing home residents, in tying financial incentives to infection control measures for the first time.

Over the years, the nursing home business has been shaped by extra fees for services performed -- such as therapy, dialysis or care for diabetes -- but with none for defending against infectious disease. Nursing home operators emphasized those services, often using the system to maximize income, while typically squeezing expenses devoted to standard nursing care. A Washington Post analysis last month found that this practice had left nursing homes acutely vulnerable to covid-19.

About 100,000 residents and employees of long-term care facilities have died of the illness, as nursing homes were caught without the resources and in many cases the staff training to stop its spread.

"These performance payments are an important stimulus for nursing homes fighting to improve their performance in a dire situation," Terry Fulmer, president of the John A. Hartford Foundation and a member of a commission on coronavirus safety in nursing homes, said in a prepared statement. "What is equally important is that we learn from facilities where infection rates were well controlled as well as learn from those facilities where infection control was unsuccessful."

Information for this article was contributed by Anne Gearan, William Booth, Erin Cunningham, Carolyn Johnson, Isaac Stanley-Becker, Will Englund and Amanda Coletta of The Washington Post; by Rob Gillies and staff members of The Associated Press; and by John Tozzi and Angelica LaVito of Bloomberg News.

Israeli Prime Minister Benjamin Netanyahu (center left) watches the arrival of more than 100,000 doses of the Pfizer coronavirus vaccine Wednesday at Ben Gurion Airport near Tel Aviv. Netanyahu said he would be the first Israeli to get the vaccine.
(AP/Abir Sultan)
Israeli Prime Minister Benjamin Netanyahu (center left) watches the arrival of more than 100,000 doses of the Pfizer coronavirus vaccine Wednesday at Ben Gurion Airport near Tel Aviv. Netanyahu said he would be the first Israeli to get the vaccine. (AP/Abir Sultan)

Upcoming Events