Advisers to the Food and Drug Administration have agreed Pfizer’s coronavirus vaccine is safe enough to use.
At the end of a day-long meeting yesterday, the 15-member Vaccines and Related Biological Products Advisory Committee was asked to consider this statement: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risks for use in individuals 16 years of age and older?”
The members voted 17-to-4 in favor of that statement, with one member abstaining.
The vote makes it all but certain the FDA will authorize the vaccine on an emergency use basis within hours or days, kicking off an unprecedented effort to inoculate enough Americans to stop the rampaging pandemic, my colleagues Laurie McGinley and Carolyn Y. Johnson write.
“If as expected, the FDA follows quickly with an emergency authorization, the shots will start being moved to the states within 24 hours, according to officials at Operation Warp Speed, the Trump administration’s effort to accelerate the development and delivery of vaccines,” they write. “Inoculations could begin early next week, officials say.”
As the distribution effort gets underway, here are five things to know:
More than 6 million doses are ready to ship instantly, but just half of them will be sent out initially.
The same goes for more doses — about 40 million in total — expected to be made available by the end of December. Leaders of Operation Warp Speed have decided to hold back half the doses, to ensure everyone who receives an initial shot can get the recommended second one.
Not everyone agrees with that approach. Some public health experts highlighted evidence that the first shot increases immunity substantially, even before the second is given. That means the government should ship out all doses as soon as they’re available, they argued.
Former FDA commissioner Scott Gottlieb told USA Today that were he in charge, he would send out all doses right away and presume the second doses will be available when people need them.
“We should get as many shots in our arms as possible right away,” Gottlieb told the newspaper’s editorial board. “The idea that we need to cut [the doses] in half and give half of it now and hold onto it, so we have supply in January to get the second dose … I just fundamentally disagree with that.”
Nicholas Bagley, a health law professor at the University of Michigan:
Harvard professor Juliette Kayyem:
Hospitals and doctors’ offices will order all vaccines through the CDC.
Medical providers must have enrolled with the CDC to provide vaccine shots. State health departments have been involved in identifying potential distributors and helping to get them signed up.
Enrollees may request doses through the CDC’s Vaccine Administration Management System (known as VAMS). They’ll be allowed to order between 975 doses and 4,875 doses of the Pfizer vaccine every week. Drug makers and distributors will access the orders through that system.
Pfizer will deliver its vaccines directly to health providers.
The deliveries will be coordinated by Operation Warp Speed, and they’ll go to pre-identified large health systems with the ability to store it at the ultracold conditions required for Pfizer’s vaccine.
A second vaccine candidate being considered next week, this one from Moderna, will be distributed through McKesson once it is approved. McKesson, which is the main distributor of seasonal flu vaccines, has been contracted by Operation Warp Speed to handle coronavirus vaccine distribution.
And it’s not just the vaccine that providers need. They’ll also require diluents, needles and syringes. The intent is to get all the supplies to providers within a day-and-a-half so the shots can be administered without risk of spoiling.
“We have built the distribution system in a way that all three of these elements will arrive within a 36-hour period of time,” Anita Patel, deputy of the CDC’s vaccine task force, told the advisory panel yesterday.
CVS and Walgreens will administer vaccines to the highest-priority group: long-term care residents.
Residents of nursing homes and long-term care facilities — where 40 percent of covid-19 deaths have occurred — are first in line to get the vaccines, along with front-line health-care workers.
Together, these groups include about 17.6 million people, or 7 percent of the adult population in the United States. The Kaiser Family Foundation estimates there are 800,000 assisted living residents, 1.2 million nursing facility residents and roughly 15.5 million adults working in health-care settings who have direct patient contact.
Getting the vaccines to health-care workers is relatively straightforward. But the government has created a special program for getting doses into nursing homes — a harder task.
More than 80 percent of nursing facilities — and in many state, more than 90 percent — are participating, Patel said. It will work like this: Walgreens and CVS pharmacies will administer shots on-site. State public health departments will help to coordinate with the pharmacies to ensure they have access to the facilities.
The advisory panel pressed FDA officials on the safety of Pfizer’s vaccine.
They raised questions about adverse reactions reported Wednesday, when two health-care workers had severe reactions after receiving the first dose. British authorities said both workers have a history of serious allergies. Susan Wollersheim, a medical officer in the FDA’s Office of Vaccines Research and Review, said the FDA has asked Pfizer to monitor vaccine recipients for “anaphylactic reactions” as a potential risk.
In its own review of the Pfizer data, FDA found a slightly higher number of adverse events — “potentially representing allergic reactions” — in the group that received the vaccine, compared with those who got the placebo. “There were 137 “hypersensitivity-related” reactions to the vaccine, compared with 111 such events in the placebo group,” Laurie and Carolyn write. “But there were no cases of anaphylactic reactions in the trial.”
But if many Americans worry about severe reactions from the vaccine, that could be a barrier to getting enough people vaccinated. A specific study to see if the vaccine carried risk to people with severe allergies could help, panel members suggested.
“There are tens of millions of people in this country that carry EpiPens because they have peanut allergies and egg allergies,” said Paul Offit, a pediatrician and vaccine expert at the Children’s Hospital of Philadelphia. “They are going to believe that they can’t get this vaccine. That is a lot of people.”
Ahh, oof and ouch
AHH: Biden’s team says it has a plan to keep White House staff members safe.
“Small and infrequent public events. Repeated testing of staff, reporters and the president-elect. Aides debating policies and Cabinet picks without ever meeting face-to-face. Preparations for a pared-down, mostly virtual inauguration. Joe Biden’s team has meticulously carried the virus safety practices of his campaign over to the transition. And his staff plans to take that approach to the White House on move-in day,” Politico’s Alice Miranda Ollstein and Daniel Lippman report.
The strategy is aimed toward keeping the virus at bay even as it reaches record rates around the country. Biden and his closest circle have so far managed to avoid infection, in stark contrast with the Trump White House, where those who have been infected include the president and his family, along with dozens of staffers and advisers, including, most recently, his personal lawyer Rudy Giuliani.
But norms may play just as strong a role as rules.
“I think the social penalties for non-mask wearing will be great. Instead of people being ridiculed for wearing masks, they’ll be pressured in the other direction. It’ll be hard to be in a meeting and not wear a mask or social distance,” Nicole Lurie, a top HHS official under President Barack Obama who has advised Biden on the pandemic, told Politico.
The safety protocols are reassessed every two weeks. So far, they have meant little face-to-face contact as Biden puts together his new team. Most staffers and incoming officials continue to work from home, and interviews and meetings are often conducted over video or phone call.
OOF: A Democratic lawmaker is accusing the CDC director of destroying an email showing political interference.
Rep. James E. Clyburn (D-S.C., chairman of the House coronavirus subcommittee, sent a letter to CDC Director Robert Redfield, citing “serious concern about what may be deliberate efforts by the Trump Administration to conceal and destroy evidence that senior political appointees interfered with career officials’ response to the coronavirus crisis at the Centers for Disease Control and Prevention.”
Clyburn’s letter, which also went to Redfield’s superior, Health and Human Services Secretary Alex Azar, cited an interview with a career CDC official who claimed that she had been instructed to delete an email that sought to interfere with scientific guidance, Lenny Bernstein and Lena H. Sun report.
Charlotte Kent, editor in chief of the CDC’s most authoritative publication, the Morbidity and Mortality Weekly Report, told congressional staff that she received instructions to delete an email written by Paul Alexander, a senior adviser to Azar, according to a transcript of the conversation. She claimed she was told that the instructions came from Redfield, down the chain of command.
According to Clyburn, the Aug. 8 email from Alexander objected to an MMWR report on coronavirus spread among children, accusing the CDC of exaggerating the risk in an attempt to hurt the president. In the end, the language of the MMRW report was not changed.
An HHS spokesperson called the subcommittee’s characterization of the interview with Kent “irresponsible” and also accused a staff member on the subcommittee of violating attorney-client privilege.
OUCH: Redfield warned that daily virus death tolls will exceed 9/11 for the next two to three months.
“We are in the time frame now that probably for the next 60 to 90 days we’re going to have more deaths per day than we had at 9/11 or we had at Pearl Harbor,” Redfield, the CDC director, said in a virtual meeting hosted by the Council on Foreign Relations.
Redfield warned that the pending coronavirus vaccine approval will not stem the staggering loss of life in the next couple of months and urged Americans to double down on precautions, including wearing a mask and avoiding social gatherings, Meryl Kornfield reports.
“The nation surpassed the toll from 9/11 — 2,977 deaths — Wednesday with 3,140 deaths related to the virus, according to Washington Post analysis,” Meryl writes.
“Redfield said the nation’s lack of health equity and the population’s disproportionate comorbidities has contributed to the country’s grim death count. The United States is ranked No. 13 among countries with the highest mortality rates per capita,” she continues.
In the courts
The Supreme Court ruled that states can regulate pharmacy benefit managers.
“The ruling is a victory for 45 states, led by Arkansas, and independent pharmacies that sought to stop so-called PBMs, which process prescription drug claims and then reimburse pharmacies, from keeping reimbursement rates low for generic drugs. That has caused thousands of independent pharmacies to close, particularly in rural areas,” USA Today’s Richard Wolf reports.
Pharmacy benefit managers act as middlemen between insurers, drug companies and pharmacies. Part of their job is to negotiate discounts with drug companies, but they’ve come under fire from lawmakers who argue that PBM pricing schemes end up driving drug prices higher. A law in Arkansas was aimed at curbing a practice in which PBMs reimburse pharmacies at a lower rate than they charge health plans. The state argued that the gap in pricing pushed some rural pharmacies out of business.
At stake in the court’s decision was the question of whether federal law permitted states to regulate the rates at which pharmacy benefit managers reimburse pharmacies. The Pharmaceutical Care Management Association, a trade group for benefit managers, argued that state laws, including that of Arizona, were in violation of the Employee Retirement Income Security Act, a 1974 law that limits state jurisdiction over certain health benefits.
A federal court refused to reimpose abortion pill restrictions during the pandemic.
U.S. District Judge Theodore D. Chuang in Maryland rejected the Trump administration’s effort to reinstate an FDA rule that require women seeking abortion medication to make an in-person visit to a clinic or medical facility during the pandemic, Ann E. Marimow reports.
Chuang issued a nationwide injunction against the FDA rule in July, arguing that the pandemic made a visit to a medical provider unduly burdensome. While the Supreme Court turned down the Trump administration’s request to reimpose the rule, it sent the case back to Chuang to determine if circumstances had changed since he originally blocked the rule. The federal judge determined that they had not.
“In his ruling Wednesday, Chuang emphasized that coronavirus infection rates have only increased since the summer. States throughout the country are imposing more stringent public health measures, he wrote, and there are persistent barriers to in-person visits, such as child care and transportation,” Ann writes.
On the Hill
A New Yorker piece is asking whether Sen. Dianne Feinstein is struggling with cognitive decline.
An article by the New Yorker’s Jane Mayer cites anonymous aides who claim that the 87-year-old Democrat from California is now struggling to remember conversations. In a Nov. 17 hearing, the Senate Judiciary Committee chairwoman asked Jack Dorsey, CEO of Twitter, the same question twice.
Some former aides told the New Yorker that rumors of Feinstein’s cognitive decline were exaggerated and that anyone can look foolish in videos taken out of context.
“But many others familiar with Feinstein’s situation describe her as seriously struggling, and say it has been evident for several years,” Jane writes.
The discussion about Feinstein may signal a broader shift. In the Senate, where the average age of a lawmaker is nearly 62, the heath issues and infirmaries of old age have often been whispered about, but social media is exposing politicians to greater public scrutiny.
