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After storms, race on to get shots back on pace

by Compiled by Democrat-Gazette Staff From Wire Reports | February 20, 2021 at 4:19 a.m.
President Joe Biden talks with a worker while touring a Pfizer covid-19 vaccine manufacturing site Friday in Portage, Mich. More photos at arkansasonline.com/220dc/ and arkansasonline.com/220covid19/. (The New York Times/Doug Mills)

PORTAGE, Mich. -- President Joe Biden toured a state-of-the art coronavirus vaccine plant Friday as extreme winter weather across the U.S. handed his vaccination campaign its first major setback, delaying shipment of about 6 million doses.

The disruptions caused by frigid conditions, snow and ice left the White House and states scrambling to make up lost ground as three days' worth of vaccine shipments were delayed. The president's trip to see Pfizer's largest plant had been pushed back a day because a storm was affecting the nation's capital.

At the Michigan plant, Biden walked through an area called the "freezer farm," which houses some 350 ultracold freezers, each capable of storing 360,000 doses of the Pfizer-BioNtech vaccine. Double-masked, the president stopped to talk with some of the workers, but it was difficult for reporters on the trip to hear what was said.

Earlier in the day, White House coronavirus response adviser Andy Slavitt said the federal government, states and local vaccinators are going to have to redouble their efforts to catch up after the interruptions. The setback occurred just as the vaccination campaign seemed to be on the verge of hitting its stride. All the backlogged doses should be delivered in the next several days, Slavitt said, confident that the pace of vaccinations will recover.

Biden has set a goal of administering 100 million shots in his administration's first 100 days, and before the storms it seemed likely that could be accomplished easily.

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The plant Biden toured, near Kalamazoo, produces one of the two federally approved covid-19 shots. According to the CDC, the two-dose Pfizer-BioNtech vaccine has been administered about 30 million times since it received emergency use authorization from the Food and Drug Administration on Dec. 11.

Nonetheless, bad weather forced many injection sites to temporarily close, from Texas to New England, and held up shipments of doses.

Slavitt said the 6 million doses delayed won't spoil and the vaccine is "safe and sound" under refrigeration.

But as shipments resume and scale up, vaccinators in communities across the country are going to have to work overtime to get shots into arms. "We as an entire nation will have to pull together to get back on track," Slavitt told reporters at the White House coronavirus briefing.

Slavitt said about 1.4 million doses were being shipped Friday as the work of clearing the backlog begins.

A confluence of factors combined to throw off the vaccination effort. First, shippers like FedEx and UPS and pharmaceutical distributor McKesson all faced challenges with snowed-in workers. Then, said Slavitt, road closures in many states kept trucks from delivering their assigned doses of vaccine. And finally, more than 2,000 vaccination sites were in areas with power blackouts.

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Still, the government is going ahead with plans to open five new mass vaccination centers, one in Philadelphia and four others in the Florida cities of Miami, Orlando, Tampa and Jacksonville.

The U.S. had administered an average of 1.7 million doses per day in the week that ended Tuesday, evidence that the pace of the vaccination program was picking up. Now, the question is how long it will take to recover from the impact of the weather-related delays.

Press secretary Jen Psaki said the White House was closely monitoring vaccine deliveries and working with manufacturers, shipping companies and states to speed their distribution.

The delays were so severe that Massachusetts Gov. Charlie Baker on Thursday suggested that he would explore sending his state's National Guard to collect doses from icebound shipping hubs in Memphis and Louisville, Ky.

The Republican governor said the state "may have some real issues with supply delivery this week," and "we have been told it would be a few days late, based on some of the issues around weather in other parts of the country."

The Virginia Department of Health reported Thursday that it was expecting delays on about 90% of its expected 120,000 doses this week and warned that the delays could cascade into next week.

"Even if the roads are clear in Virginia, the fulfillment of orders and the movement of these vaccine and ancillary supplies may be delayed in other parts of the country," the department said in a news release.

In North Carolina, none of the more than 163,000 first and second doses of the Moderna vaccine scheduled to arrive this week has been delivered by Biden's administration, the state health department said. The state also noted that only a limited number of the nearly 127,000 expected Pfizer vaccines have been shipped.

Oklahoma moved to reschedule vaccine clinics to this weekend, when it expects its 110,000 doses to be delivered, aiming to make up appointments from this week.

SETBACKS OUT WEST

The ripple effects extended far beyond areas experiencing winter weather. In Arizona, the bulk of the state's anticipated shipment of Moderna doses was delayed until early next week, forcing the postponement of some vaccination appointments.

Los Angeles Mayor Eric Garcetti postponed more than 12,000 vaccinations at city-run sites scheduled Friday after two shipments of Moderna vaccine were delayed because planes couldn't fly in the weather. He said Thursday that the city is automatically rescheduling many canceled slots and prioritizing second-dose appointments.

"It's a nationwide problem," Garcetti said at a news conference. "We are in a race against time, a race between infections and injections, and anything that slows down our progress is unacceptable."

Confusion followed when hundreds of people still showed up at Dodger Stadium for vaccine appointments scheduled Friday morning. Some told station KTLA that they never received a cancellation notice. Southern California has been especially hard-hit by the coronavirus, with a winter surge that stretched hospitals to their limits and exhausted oxygen supplies.

In New York City, officials could not schedule more than 30,000 appointments this week and delayed the opening of new vaccination sites in Queens and Staten Island because of delayed shipments. Mayor Bill de Blasio, like other local leaders, said the weather delays aggravated an already stressed distribution system providing far fewer doses than needed.

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"It's been too hand-to-mouth in general, and then it's been made even worse by the storm," de Blasio said at a Thursday news conference. "There are so many things that we could be doing right now to get tens of thousands more people vaccinated, but unfortunately, Mother Nature now is causing us the most immediate problem with these supply delays, and we of course will overcome them and keep moving forward."

There have been few reports of vaccines spoiled because of power failures. Houston garnered some attention after officials rushed to administer more than 5,000 doses of the Moderna vaccine in one day, but Moderna staff members later assured the city the thawing vials could be safely refrozen.

The White House is encouraging states to extend hours for vaccination clinics once they reopen and to swiftly rebook postponed appointments.

"We want to make sure that as we've lost some time in some states for people to get needles in arms, that our partners do all they can to make up that lost ground," said coronavirus coordinator Jeff Zients.

VARIANT QUESTIONS

Meanwhile, Biden administration officials, pharmaceutical companies and scientists are racing to get ahead of a virus that has become a more aggressive shape-shifter than many expected. But they are confronting basic questions about where the variants are spreading, how quickly to update the vaccines and whether more problems are just over the horizon.

The threats from more-transmissible variants are "a huge topic with everybody in the White House, and everyone wants to make sure we have viable strategies," Slavitt said in an interview. "But part of it is we need to learn more."

Among the unknowns: Will one variant -- for instance, the highly transmissible version that shut down the United Kingdom -- become dominant here, or will the number of mutant strains expand? Will existing vaccines, and others on the runway, offer sufficient protection against the new variants? And if not, should companies target the most worrisome strain, or develop an injection that covers several of them?

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Drug companies already have started working on updating their vaccines against more-transmissible variants -- a move encouraged by government officials.

"What we are saying is, 'Go ahead and study them, get them ready to go," said a health official who spoke on condition of anonymity to discuss the message conveyed to manufacturers. "You do a construct for the 351 variant [first detected in South Africa], test it in people and get all the information. If you need it a few months from now, you have it. You essentially hold them in the freezer" until needed.

While the current shots by Pfizer-BioNTech and Moderna use a new technology that allows for speedy modifications, changing vaccines adds wrinkles to manufacturing and distribution schemes that are already complex.

"It's a big decision to have a strain change," said Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland School of Medicine. "It has to be a very thoughtful approach."

The next few months are shaping up as a pivotal chapter in what could be a long-running contest between vaccines and variants, including those first detected in South Africa and Brazil, as well as the United Kingdom. Even as coronavirus infections and hospitalizations have plunged in recent weeks, experts worry upstarts could spoil an improving picture. Studies in lab dishes have shown that while the Pfizer-BioNTech and Moderna vaccines appear to be highly effective against the U.K. variant, officially known as B.1.1.7, they had a decreased ability to neutralize the South African version, or B.1.351.

Pfizer, in a statement responding to the studies, said it doesn't believe the data translates into "a significant reduction in protection" against B.1.351, but the company is taking steps "to be in a position to develop and seek authorization for an updated mRNA vaccine or booster" if needed.

1-SHOT EFFECTIVENESS

Separately, a study in Israel showed that the Pfizer vaccine is robustly effective after the first shot, echoing what other research has shown for the AstraZeneca vaccine and raising the possibility that regulators in some countries could authorize delaying a second dose instead of giving both on the strict schedule of three weeks apart as tested in clinical trials.

Although regulators in the United States have held fast to the requirement that people receive two doses of the Pfizer vaccine three weeks apart, the British government decided to prioritize giving as many people as possible an initial dose, allowing delays of up to 12 weeks before the second dose. The Israeli study could bolster arguments for emulating that approach in other countries.

Published Thursday in The Lancet and drawing from a group of 9,100 Israeli health care workers, the study showed that Pfizer's vaccine was 85% effective 15 to 28 days after receiving the first dose. Pfizer's late-stage clinical trials, which enrolled 44,000 people, showed that the vaccine was 95% effective if two doses were given three weeks apart.

Dr. Anthony Fauci, the nation's leading expert on infectious diseases and an adviser to Biden, said at a White House news conference Friday that the results of the study are not significant enough to change the U.S. recommendations.

He said the people in the study were on the younger and healthier side and the researchers could not say how long the protection from one shot of the vaccine would last. He also said it was possible that a less-than-optimal dose might not kill the most powerful variants of the virus, theoretically allowing them to spread more quickly in the population.

"We want the public not to be confused. The recommendation from the FDA is two doses, just as it always has been," Slavitt said during the briefing.

Pfizer and BioNTech also announced Friday that their vaccine can be stored at standard freezer temperatures for up to two weeks, potentially expanding the number of smaller pharmacies and doctor offices that could administer the vaccine, which now must be stored at ultralow temperatures.

In a statement, the companies said they have submitted the new temperature data to the Food and Drug Administration, which would need to sign off on guidance to providers that would allow them to store the vaccines at the new temperatures.

Information for this article was contributed by Zeke Miller and Ricardo Alonso-Zaldivar of The Associated Press; by Fenit Nirappil, Amy Goldstein, Lateshia Beachum, Matt Viser, Laurie McGinley, Christopher Rowland and Lena H. Sun of The Washington Post; and by Katie Thomas of The New York Times.

President Joe Biden tours a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. (AP Photo/Evan Vucci)
President Joe Biden tours a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. (AP Photo/Evan Vucci)
President Joe Biden tours a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. (AP Photo/Evan Vucci)
President Joe Biden tours a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. (AP Photo/Evan Vucci)
President Joe Biden stands at the top of the steps of Air Force One at Andrews Air Force Base, Md., Friday, Feb. 19, 2021. Biden is heading to Michigan to visit a Pfizer vaccine manufacturing plant near Kalamazoo. (AP Photo/Susan Walsh)
President Joe Biden stands at the top of the steps of Air Force One at Andrews Air Force Base, Md., Friday, Feb. 19, 2021. Biden is heading to Michigan to visit a Pfizer vaccine manufacturing plant near Kalamazoo. (AP Photo/Susan Walsh)
President Joe Biden waves from the top of the steps of Air Force One at Andrews Air Force Base, Md., Friday, Feb. 19, 2021. Biden is heading to Michigan to visit a Pfizer vaccine manufacturing plant near Kalamazoo. (AP Photo/Susan Walsh)
President Joe Biden waves from the top of the steps of Air Force One at Andrews Air Force Base, Md., Friday, Feb. 19, 2021. Biden is heading to Michigan to visit a Pfizer vaccine manufacturing plant near Kalamazoo. (AP Photo/Susan Walsh)
President Joe Biden, Michigan Gov. Gretchen Whitmer, third from right, and Jeff Zients, White House coronavirus response coordinator, right, tour a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. (AP Photo/Evan Vucci)
President Joe Biden, Michigan Gov. Gretchen Whitmer, third from right, and Jeff Zients, White House coronavirus response coordinator, right, tour a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. (AP Photo/Evan Vucci)
President Joe Biden tours a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. Michigan Gov. Gretchen Whitmer and Albert Bourla, Pfizer CEO look on. (AP Photo/Evan Vucci)
President Joe Biden tours a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. Michigan Gov. Gretchen Whitmer and Albert Bourla, Pfizer CEO look on. (AP Photo/Evan Vucci)
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