Thursday, January 21, 2021

US plan to vaccinate most Americans by summer depends on AstraZeneca and J&J

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The U.S. government’s plan to vaccinate most Americans by next summer is largely based on two injections of COVID-19 that U.S. regulators won’t have a chance to comment on until early 2021.

AstraZeneca Plc and Johnson & johnson together would provide 150 to 200 million shots in the first quarter, said Moncef Slaoui, scientific director of Operation Warp Speed. This could immunize 110 to 150 million people, if the doses are split evenly between J & J’s single-dose vaccine and Astra’s two-dose regimen.

This is in addition to the vaccines of Pfizer Inc. and Moderna Inc., from whom the United States has ordered enough doses for 100 million people combined.

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Slaoui detailed the plan in response to criticism that the United States has left itself exposed by refusing to order more doses from New York-based Pfizer, whose vaccine is expected to be cleared for emergency use in the coming days. . At the White House vaccine summit on Tuesday, Slaoui defended the strategy of spreading betting among vaccine manufacturers by relying on different technologies. The goal: to ensure the plan is not hampered by individual clinical failure, manufacturing delay or poor execution by management, he said.

“Already with this portfolio, I am confident that we can cover the US population in the first half of 2021,” Slaoui said at the Milken Institute’s Future of Health summit. Later, during the White House meeting, Slaoui clarified that anyone who wanted a vaccine would have access to it in June.

The United States has reached an agreement for 100 million doses of the Pfizer-BioNTech SE two-dose vaccine schedule, enough for 50 million people. Both injections are necessary to ensure full immunity. The New York Times and the Washington Post reported on Monday that Pfizer had offered an additional 100 million doses to the United States, which declined.

Scott Gottlieb, the former head of the Food and Drug Administration who now sits on Pfizer’s board of directors, told CNBC on Tuesday that the offer remains on the table even after Pfizer released data showing the vaccine was very effective in a clinical trial. Eventually, other countries took their place ahead of the United States, and now Pfizer’s home country would have to wait until late summer to get more doses.

Without more Pfizer vaccines at this time, estimates of when the United States can achieve herd immunity could be at risk unless the United States can get more doses elsewhere, Morgan stanley Analyst Matthew Harrison said in a research note. Harrison had modeled vaccinations reaching a tipping point in mid-2021.

Previous discussions

In previous negotiations with the United States, Pfizer did not guarantee that it would be able to deliver an additional 100 million doses within a specified time frame, according to a White House official who asked not to be identified by discussing private information.

The parties remain in talks on whether the United States will exercise an option to purchase additional doses, the official said. Pfizer declined to comment on negotiations with the government.

At Tuesday’s White House summit, President Donald Trump raised the specter of invoking the Defense Production Act – which allows the president to force companies to prioritize contracts deemed essential to national security – if the United States is struggling to get the vaccine for its citizens.

However, since more doses of Pfizer are not available in the short term, based on current agreements, the US needs AstraZeneca and J&J to present data to the FDA showing that their vaccines are effective. and safe.

J&J trial

Currently, J&J has recruited more than 35,000 healthy participants for an advanced clinical trial, for which it hopes to recruit 60,000 people.

Slaoui expects provisional trial data to be read in early January, although J&J executives have said they plan to report the data towards the end of the month. Warp Speed’s chief scientist added at the White House event that he anticipates J&J firing will get the green light from U.S. regulators in late January or early February.

The United States has so far obtained enough doses for 100 million people.

Meanwhile, the AstraZeneca and Oxford University clinical trial in the United States has enrolled 17,000 participants out of its goal of 40,000 people, and will only read in late January or early February, with the possibility of a emergency use authorization pending. towards the end of February or the beginning of March, according to Slaoui.

Outside the United States

Astra and Oxford have a separate trial underway outside of the United States, which reported more moderate effectiveness than injections from Pfizer and Moderna. The United States has reached a deal for 300 million doses of the Astra-Oxford vaccine, which also requires an injection and booster regimen.

Because they use different technology, AstraZeneca and J&J could scale up manufacturing much faster than Pfizer and Moderna, Slaoui said.

A third group of vaccines, one from Novavax Inc. and the other from Sanofi and GlaxoSmithKline Plc, could be cleared in the spring for use in April or May, he said. “These can also produce hundreds of millions of doses,” Slaoui said.

Moderna Agreement

If all of these candidates fail in one way or another, the United States still has an additional supply option from Moderna, whose vaccine is awaiting FDA clearance later this month.

Moderna’s initial supply deal with the United States for 100 million doses allows the government to order another 400 million, according to Moderna spokesman Ray Jordan. A price of $ 16.50 per dose has already been agreed and no further negotiation is required.

The specific dates of acceptance and delivery of the option agreements – which can be done in four installments of 100 million doses – were not disclosed, Jordan said.

Any additional orders for Moderna fire from the United States would be fulfilled by factories in New Hampshire and Massachusetts, and the United States would have priority over production from those factories, Jordan said. A separate factory in Switzerland is used to deliver doses to Europe, he said.

Given the timing of the manufacturing scale-up, most of any additional U.S. offerings would not be delivered until the second quarter of 2021.

However, in a note to customers on Tuesday, Harrison of Morgan Stanley said the U.S. government acceptance period would begin after the Moderna vaccine obtained emergency clearance.

“We believe the US government can act quickly,” he wrote. And that if the United States exercised its options, Moderna “could provide the vast majority of doses to the United States”

One potential hurdle would be whether Moderna could get enough raw materials to make all of these vaccines, he said. Slaoui said during the Milken Institute event that Operation Warp Speed ​​anticipated this obstacle and is currently helping various vaccine manufacturers acquire such materials.

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