Biden urges states to speed up COVID-19 vaccinations for teachers

Game-changing one-dose vaccine could be in states’ hands shortly

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WASHINGTON —States struggling to provide enough COVID-19 vaccines are likely just a few days away from a pivotal development in the vaccination race: the availability of a shot that requires only one dose.

The game-changing Johnson & Johnson vaccine would differ from the two current shots by Pfizer and Moderna in several critical ways. By requiring just one dose, individuals won’t need to return several weeks later for an additional shot.

That will be significant help in rural areas, and other places where residents are far from vaccination sites.

It also has easier storage requirements than the current shots, which need extra-cold temperatures, and it can be kept in a standard refrigerator for at least three months

The Johnson & Johnson vaccine is awaiting emergency-use authorization from a critical Food and Drug Administration panel on Friday, followed by the agency’s final decision, expected shortly.

The company is under contract to provide 100 million doses by the end of June, which would help to reduce a bottleneck of too-few vaccines for the huge national demand.

But J&J has faced challenges to ramp up its production, with fewer doses ready to ship out than what’s outlined in its federal contract. The company has acknowledged the difficulties, and is now teaming up with French drugmaker Sanofi to help boost its output.

“This has been an unprecedented effort to scale up manufacturing for a vaccine against a disease that didn’t even exist more than a year ago,” Dr. Richard Nettles, a J&J vice president, told lawmakers during a congressional hearing Tuesday.

Maryland manufacturer

Critical to that production effort has been a Maryland biomedical plant, Emergent BioSolutions, which is manufacturing the drug substance for the Johnson & Johnson vaccines at its Baltimore facility.

The company also relies on production facilities in Indiana, Michigan, and Pennsylvania, where the vaccine vials are filled and finished.

President Joe Biden’s COVID-19 advisers say they’ve also been working with Johnson & Johnson to ramp up production.

“We’ve helped them with equipment and raw materials, which I think is helping to increase greater capacity and accelerate,” Jeff Zients, coordinator of the White House’s COVID-19 task force, said on Wednesday.

Once federal regulators grant the green light, 4 million doses are ready to be shipped, with 20 million to be delivered by the end of March.

Zients said he spoke with governors on Tuesday about the plans to roll out the vaccine “without delay” if authorization is granted, using the same distribution formulas as with the previous vaccines.

“It is going to be game-changing because more people are going to have access to the vaccine in ways that are more convenient to them,” said Neil Sehgal, assistant professor of health policy and management at the University of Maryland’s School of Public Health.

An FDA analysis of the vaccine released Wednesday found it provides strong protection against severe disease and death from COVID-19. It had a 72 percent overall efficacy rate in the U.S., and 64 percent in South Africa, where one of the highly contagious variants emerged.

The Pfizer and Moderna vaccines have high efficacy rates. But Seghal and other public health experts have emphasized that the J&J vaccine has a higher efficacy rate when looking specifically at preventing severe COVID-19 infections, and the company’s trials showed it provided “complete” protection against hospitalizations and deaths due to the virus.

“If the goal is to prevent hospitalizations and deaths, there’s no difference” between the J&J vaccine and the ones from Pfizer and Moderna, he said.

More vaccines on the way

The J&J vaccine is far from the last in the regulatory pipeline.

Maryland’s Emergent also has ties to another vaccine that may come before federal regulators in the coming months: The company has a manufacturing contract with U.K.-based AstraZeneca, which has a vaccine that is in clinical trials in the U.S.

The J&J vaccine’s Maryland ties won’t give the state a leg up in seeking doses, which are allocated through the federal government. Still, Baltimore Mayor Brandon Scott wrote to Johnson & Johnson last month, asking the company to sell 300,000 of its vaccine doses directly to the city, arguing that doing so would help the city to speed up the delivery of shots to residents of color.

That’s unlikely to happen. After Friday’s all-day hearing of the FDA’s vaccine advisory committee and then a final sign-off by the agency’s top officials, the doses would head around the country in the same proportions as the Pfizer and Moderna shots.

“We’ll be proud to be saving people in other states too,” Maryland Gov. Larry Hogan told reporters earlier this month after touring the Emergent facility.

Big uptick in vaccine supplies for states expected soon

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WASHINGTON — Executives from five COVID-19 vaccine manufacturers told Congress Tuesday that they expect to significantly boost the number of shots delivered to states in the coming weeks.

Pfizer will increase weekly shipments to more than 13 million doses by mid-March, an increase from the 4 to 5 million doses shipped weekly in early February, the company’s chief business officer, John Young, told a U.S. House panel.

Moderna, the other vaccine that has received federal authorization for emergency use, expects to double its monthly vaccine deliveries by April to more than 40 million doses per month.

If a third vaccine from Johnson & Johnson is authorized by the Food and Drug Administration, which could happen as soon as this weekend, the company says it can deliver enough single-dose shots by the end of March to vaccinate more than 20 million Americans.

Those anticipated boosts in production would ease a bottleneck in the national effort to vaccinate Americans: The Biden administration is frantically seeking ways to distribute more doses to state public health officials, who say they have the capacity to get more shots into arms than they currently are administering.

Pfizer — whose COVID-19 vaccine was the first to receive FDA emergency authorization — had shipped 40 million vaccine doses as of mid-February. Moderna’s president, Dr. Stephen Hoge, said the company had delivered 54 million doses as of last week.

Both companies say they are on track to deliver 300 million doses each by the end of July.

More doses in each vial

Officials for Pfizer and Moderna said they’ve sought to boost output by adding doses to each vial, increasing batch sizes, and adding production lines to their manufacturing sites.

“We recognize the need to vaccinate more people, more quickly, and have worked hard to significantly increase production,” Young said during Tuesday’s hearing of the House Energy and Commerce Committee’s oversight panel.

Rep. Diana DeGette, (D-Colo.), who chairs the oversight subcommittee, commended the vaccine manufacturers for their efforts, but noted that many of the companies testifying Tuesday received “significant federal investments” to build their manufacturing capacity and ensure vaccines could be rolled out immediately.

“Frankly, we still face a lack of vaccine supply to meet current demand,” DeGette said.

Additional doses could be on the way soon if the FDA gives emergency authorization to the Johnson & Johnson vaccine, which goes before an agency panel on Friday. Once the company receives the green light, 4 million doses could be shipped immediately, said Dr. Richard Nettles, vice president of U.S. medical affairs.

A vaccine from U.K.-based drug company AstraZeneca is still in clinical trials, but company officials said that if emergency use is granted, up to 50 million doses could be available by the end of April.

Another vaccine from Maryland-based Novavax could boost availability by another 100 million doses by the end of June.

Effectiveness in teens

More data is on the way regarding how effective the vaccines are for teenagers. Officials from Pfizer and Moderna said they are currently studying the effectiveness in those as young as 12 years old.

Amid concerns about new variants of the virus now circulating in the U.S., Young said Pfizer has seen “no real world evidence” so far to indicate that its vaccine is less effective against new variants. But both Pfizer and Moderna officials said they are studying the need for any booster shots.

As for looming concerns about whether the vaccines reduce asymptomatic transmission of the virus and how long it will offer protection from infection, the manufacturers said those answers will require further study.

“Unfortunately, the only real way we will know about the duration of that protection is over time,” Hoge said.

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