with Alexandra Ellerbeck
But experts warn that’s a best-case scenario — and could easily be derailed by any number of blunders along the way.
It requires not only manufacturing of more than 600 million doses of the two-shot vaccine, but also transporting it to all corners of the country, making it accessible to Americans of all stripes, and persuading them it's safe.
“I think that is very optimistic of Moncef,” said Norman Baylor, who formerly directed the Office of Vaccines Research and Review at the Food and Drug Administration. “It’s possible if everything worked out perfectly.”
Slaoui is nonetheless laying out an ambitious timeline for vaccine approval, manufacturing and distribution.
Back in August, he projected having just 300 million doses ready by the middle of next year, in a piece published by the New England Journal of Medicine.
But since then, preliminary analysis has found vaccine candidates developed by Pfizer and Moderna to be highly effective and safe, buoying his predictions of what might be possible. British regulators announced this morning they have granted emergency authorization to Pfizer's vaccine, and will start distributing the first 800,000 doses next week.
“Two different vaccines developed by two different companies tested in two different clinical trials are yielding remarkable data,” Slaoui said.
Here’s a best-case timelime for how all this could play out in the U.S. — although it isn’t set in stone and could easily change, especially given the many different players involved in the effort.
Dec. 4: States must submit requests for doses of Pfizer’s vaccine and where they should be shipped. The FDA hasn’t yet authorized the vaccine for emergency use, but manufacturers have already been teeing up millions of doses to be shipped out as soon as that happens.
Dec. 10: An FDA advisory committee meets to decide whether there’s enough evidence to issue an emergency use authorization for the Pfizer vaccine. It will submit its recommendations to the agency, which is expected to make a decision in the days after.
Dec. 11: States must submit requests for doses of the Moderna vaccine and where they should be shipped.
Dec. 17: The FDA advisory panel will meet again, this time to consider the evidence in the Modern vaccine trials and submit recommendations.
Mid- to late December: As soon as the FDA grants emergency use for each vaccine, private companies will rush to ship within hours doses to predetermined locations, namely, hospitals and long-term care facilities.
An advisory panel recommended yesterday that 21 million health-care personnel and 3 million residents and staff members of nursing homes be first in line for the vaccine, in what is known as “Phase 1a” of the rollout.
“These groups were deemed the highest priority by the Advisory Committee on Immunization Practices, because the vaccine will initially be in extremely short supply after it is cleared by federal regulators,” Lena H. Sun and Isaac Stanley-Becker report. “Health-care personnel are a top priority because of their exposure to the virus and their critical role keeping the nation’s hospitals and clinics functioning.
“Residents and employees of long-term care facilities were prioritized because they account for nearly 40 percent of deaths from covid-19,” they add.
By the end of December, the government is aiming to ship out 35 million to 40 million doses — enough to immunize roughly 20 million Americans. Slaoui again confirmed that figure yesterday.
January: There will be capacity to produce about 60 million to 70 million doses of the Pfizer and Moderna vaccines during this month, Slaoui said.
February: In addition to the Pfizer and Moderna production, the hope is to manufacturer and distribute an additional 30 million to 50 million doses of two more vaccines, one from Astra Zeneca and another from Johnson & Johnson, if they’re approved for emergency use.
March: Production should increase significantly in this month, with people outside priority groups beginning to get shots. Slaoui said monthly production would reach 150 million doses.
“We’ll ramp up quite quickly as of March in how many people can be immunized,” Slaoui said.
April and May: Manufacturers will be aiming for 300 million doses over these two months. If all goes according to plan, that could put the United States in the range of 600 million doses or more by June.
By this point, the goal is to have vaccinated older Americans and those with chronic conditions. The very last people to receive vaccines will probably be kids, Slaoui said.
“My personal point of view is that we should end with the least-infected populations, which means pediatric populations,” he said.
Ahh, oof and ouch
AHH: A bipartisan group of senators introduced a $908 billion stimulus plan.
The effort to break a months-long impasse on providing emergency federal relief comes after talks between the White House and House Democrats over a relief deal collapsed ahead of the Nov. 3 election. With a number of relief programs expiring at the end of the year and increasing signs that the economy is faltering, including disappointing Black Friday and Cyber Monday sales, Congress is under increasing pressure to pass a deal, Seung Min Kim, Jeff Stein and Mike DeBonis report.
Several centrist lawmakers in the Senate, including Joe Manchin III (D-W.Va.), Mark R. Warner (D-Va.), Bill Cassidy (R-La.), Mitt Romney (R-Utah) and Susan Collins (R-Maine), held a news conference Tuesday to push for the proposal, which they say reaches a middle ground on a number of contentious issues.
“[T]he substantive efforts at a compromise in the Senate reflect growing agitation from influential senators against the hard-line stances of their respective leaders,” Seung Min, Jeff and Mike write.
The deal includes $160 billion in funding for state and local governments, a top priority for Democratic lawmakers, and would provide $300 a week in federal unemployment benefits, half of the $600 a week Democrats sought. It also includes temporary moratorium on some coronavirus-related lawsuits, a measure many Republicans advocated, but which Democrats oppose.
It’s unclear if the deal will gain support among congressional leaders or with the Trump administration. Treasury Secretary Steven Mnuchin and House Speaker Nancy Pelosi (D-Calif.) held a call on Tuesday to discuss stimulus efforts, as well as a government spending bill that Congress must pass before Dec. 11 to avoid a government shutdown.
OOF: The White House is forging ahead with dozens of indoor holiday parties, despite the coronavirus surge.
“The president and the first lady are determined to have a final holiday season in the White House, officials said, despite a pandemic that has killed more than 268,000 Americans and infected 13 million across the country,” Josh Dawsey and Yasmeen Abutaleb report. “The events, including a congressional ball on Dec. 10, will each include more than 50 guests and could risk the health of White House staff and others who work at the parties. Most guests will not be tested in advance, one official said.”
A spokeswoman for Melania Trump told The Post that masks would be required and that guests would be encouraged to socially distance. Officials told The Post, however, that at a Monday afternoon reception some attendees were not wearing masks.
“[H]ealth experts expressed dismay at the plans, noting that cases are not only increasing across the country but in the Washington area specifically. They also said travel by many guests from outside D.C. would likely violate myriad state and city restrictions,” Josh and Yasmeen write.
Despite warnings from the administration’s top health officials to avoid indoor holiday gatherings, a senior Republican aide told The Post that there appears to be considerable interest among Republicans on Capitol Hill in taking part in the bipartisan annual tradition.
OUCH: The coronavirus could have been circulating in the United States in early December, according to a new study.
“The new coronavirus infected people in the U.S. in mid-December 2019, a few weeks before it was officially identified in China and about a month earlier than public health authorities found the first U.S. case, according to a government study published Monday,” the Wall Street Journal’s Betsy McKay reports.
Scientists at the U.S. Centers for Disease Control and Prevention say they found antibodies specific to the new coronavirus in blood samples donated to the American Red Cross in mid-December. The study, published in the journal Clinical Infectious Diseases, found evidence of infection in 106 of 7,389 blood samples collected between Dec. 13 and Jan. 17.
Some critics, however, argue that the early “positive” results for the novel coronavirus identified in the study are actually the result of cross-reactivity with other types of common coronaviruses.
Trevor Bedford, a professor in the vaccine and infectious-disease division of the Fred Hutchinson Cancer Research Center:
I don't think that this study by Basavaraju et al from @CDCgov can be taken as evidence that #COVID19 was circulating in the US in December 2019. 1/10https://t.co/yTjIwSvM4X— Trevor Bedford (@trvrb) December 1, 2020
More in coronavirus
The CDC plans to shorten quarantine time to 10 days, or seven with a negative test result.
“The policy would hasten the return to normal activities by those deemed to be ‘close contacts’ of those infected with the virus, which has infected more than 13.5 million Americans and killed at least 270,000,” the Associated Press’s Zeke Miller reports.
The new guidelines, which were presented Tuesday at a White House coronavirus task force meeting for final approval, reflects a deeper understanding of the incubation period for the virus. Scientists have found that most individuals become infectious and develop symptoms between four and five days after an exposure.
Ambulance companies are at “a breaking point.”
“Private EMS services, both in urban and rural centers across the country, collectively received $350 million in Covid-19 relief funds in April, but those companies said that money ran out within weeks. Months later, the need remains great as they face another coronavirus surge,” NBC News’s Phil McCausland reports.
Ambulance companies have seen their revenue strained for a number of reasons. Providers have been forced to buy expensive personal protective equipment and have seen less revenue from hospital transfers, as people put off surgeries and other medical procedures. Ambulances are also expected to treat people in place whenever possible during the pandemic, but they often don’t get reimbursed if the patient isn’t actually transported. The end result is that many of the private ambulance companies, which look after about a third of communities in the United States, are on the verge of going under.
“[T]he 911 emergency medical system throughout the United States is at a breaking point. Without additional relief, it seems likely to break, even as we enter the third surge of the virus in the Mid-West and the West,” the American Ambulance Association said in a letter sent to the Health and Human Services Department obtained by NBC News.
After millions of Americans ignored public health warnings to travel for Thanksgiving, health officials brace for Christmas.
Despite surging coronavirus cases and a recommendation from the CDC to avoid holiday travel, the past few days around the Thanksgiving holiday saw the busiest travel days since the start of the pandemic, William Wan and Brittany Shammas report. “Now, like any partygoer waking from a raucous weekend — feeling a bit hung over and perhaps a tinge of regret — the nation is about to face the consequences of its behavior and will need to quickly apply the lessons before heading into the doubleheader of Christmas and New Year’s,” William and Brittany write.
Public health experts are wondering how to retool their messaging in the coming weeks. Some experts worry that messages designed to scare people, which have grown increasingly blunt in recent weeks, can inadvertently condition people to tune out. Instead, some experts are pushing for a message that appeals to peoples’ sense of empathy.
“We have to rethink how we’re communicating. Blaming people, yelling at them, stigmatizing them — clearly it’s not working,” Angela Rasmussen, a virologist at Georgetown Center for Global Health Science and Security, told The Post. “We have to show compassion and empathy. Understand where people are coming from and persuade them to do otherwise.”
Other practical measures before Christmas include ramping up testing capacity and ensuring that airports do not become so crowded that social distancing is impossible. Officials are also urging anyone who already traveled over the Thanksgiving holiday to get tested, wear masks and avoid crowds.
Elsewhere in healthcare
The FDA has ended a program that forced drugmakers to win regulatory approval for drugs already on the market.
The Unapproved Drugs Initiative pushed drugmakers to bring older drugs that had been grandfathered in without FDA approval through the regulatory process, but the program generated pushback from critics who said that it inadvertently led to increased prices.
“The initiative generated complaints that some companies established monopolies after winning regulatory approval for a medicine, which in turn led to big price hikes or shortages in some cases,” Stat News’s Ed Silverman reports.
HHS published a notice in the Federal Register on Nov. 25 announcing the end of the program.