- The Washington Times - Monday, January 4, 2021

The fast-spreading coronavirus is forcing leaders to scramble for novel solutions to build widespread immunity this year, from delaying the second shot of the AstraZeneca vaccine that debuted in the United Kingdom on Monday to a U.S. proposal — on hold for now — to cut in half the dosage of the Moderna vaccine, even as states struggle to stick the doses they have into arms.

Brian Pinker became the first person to receive the AstraZeneca “jab,” as the British call it, outside of a clinical trial. Oxford University developed the vaccine alongside the British-Swedish drugmaker.

“I’m so pleased to be getting the COVID vaccine today and really proud it is one that was invented in Oxford,” Mr. Pinker, 82, said at Oxford University’s Churchill Hospital.

The joy of the immunization campaign was contrasted by Prime Minister Boris Johnson announcing a new national lockdown to deal with a coronavirus variant that appears to spread quickly, saying hospitalizations had increased 30% and current measures weren’t cutting it. The order likely will extend into February and close schools, nonessential stores and businesses.

“With most of the country already under extreme measures, it’s clear that we need to do more together to bring this new variant under control,” Mr. Johnson said.

The U.K. has an initial batch of 500,000 doses of the AstraZeneca vaccine but is trying to maximize early protection by giving it to as many at-risk people as possible, even if it delays second doses beyond the prescribed 28 days. British regulators said early recipients will still get their second dose within 12 weeks.
Denmark approved a delay of up to six weeks before the second dose is given, while Germany is considering it, according to Reuters.

U.S. officials and experts say even if a larger gap between shots can offer robust protection, they’re skittish about using initial doses without guaranteeing the second dose will be in hand within the prescribed interval. They want to stick to what was presented to regulators to authorize emergency use.

“Everything else, you’re guessing — that’s why you do those studies,” said Paul Offit, a pediatrics professor at the University of Pennsylvania and member of the Food and Drug Administration’s vaccine advisory panel. “We should give this vaccine based on the phase 3 data. We don’t do a phase 3 trial and then not believe it.”

Moncef Slaoui, the science adviser for Operation Warp Speed, made waves by floating a different strategy, however — cutting in half doses of the Moderna vaccine because of data that show a similar immune response in participants aged 18 to 55.

“We know it induces identical immune response to the 100-microgram dose and therefore we are in discussion with Moderna and with the FDA. Of course, ultimately it will be an FDA decision to accelerate [by] injecting half the volume,” Mr. Slaoui told CBS’s “Face the Nation” over the weekend.

FDA Commissioner Stephen Hahn and Peter Marks, who oversees vaccine approval, said late Monday the switch is a reasonable one to consider and evaluate in clinical trials, but they’re not about to change course.

“At this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence, they said. “Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.”

Some government officials are thinking big as the world contends with virus mutations that appear to spread faster.

Besides the U.K. one, there is one from South Africa that may be even worse. There’s also been an uptick in the American case count following Christmas. The seven-day rolling average of daily cases dipped 218,000 to 183,000 around Christmas but shot up again after the holiday rush, reaching 212,000.

The vaccine rollout is commencing in stages, starting with health care workers and those with high-risk jobs or medical conditions, before it reaches the general population — a process that will stretch well into 2021, leaving a perilous stretch to start the new year.

Some in the immunization field say talk of a change-up in strategy is premature. States are trying to smooth out wrinkles in distribution and use all of the initial doses they’ve received.

“If we have more arms than doses, I think that’s a legitimate discussion,” said Litjen Tan, chief strategy officer at the Immunization Action Coalition.

As it stands, more than 13 million doses of vaccine have been distributed but only 4.2 million have made it into arms, according to the Centers for Disease Control and Prevention.

Claire Hannan, executive director of the Association of Immunization Managers, said there is a natural lag in the time between the distribution of doses and the administration of them through the week, plus reporting them to the CDC. Also, states set aside a large chunk of delivered doses to ensure CVS and Walgreens had a supply available for long-term care facilities through a federal partnership, so those numbers should be recorded in the coming weeks.

“There will always be a lag between the doses allocated and those shipped; between those shipped and those administered; and between those administered and those reported to CDC as administered. We’re working to make those lags as small as possible,” the Department of Health and Human Services said in a statement.

Some states say the campaign is a learning curve. The hospitals giving shots should perfect their vaccination “clinic flow” over time, for example.

There have been other hiccups, including ones related to the calendar. For instance, Pennsylvania authorities said they contended with a major snowstorm, slowdowns from the Christmas and New Year’s Day holidays, and the surge in hospitalizations from the uptick in cases, meaning the people they are trying to vaccinate are focused on patients.

“Our health care heroes are not only working to vaccinate critical health care personnel, but they are caring for patients who are overwhelming hospitals,” said Pennsylvania Health Department spokeswoman Rachel Kostelac.

Dr. Tan said part of the delay is caused by the “deliberateness” of the distribution to health care workers.

Hospitals stagger their rollout among staff. If recipients develop a fever from the vaccine, they are taken out of the workforce until it’s clear whether they have COVID-19.

“Hospitals can’t vaccinate everyone at once,” Dr. Tan said.

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