J&J Sees Decision on Vaccine Clearance Coming by March

Johnson & Johnson’s highly anticipated single-dose Covid-19 vaccine may not be authorized for use until March, weeks later than U.S. officials have suggested.

Operation Warp Speed officials have said they believe that the shot could receive emergency clearance from U.S. regulators as soon as the middle of next month. But that timeline may be aggressive, based on the drugmaker’s expectations for when it will have reliable data in hand demonstrating the one-shot vaccine’s efficacy.

J&J will first have its chance to analyze late-stage data in the last week of January or the first week of February, Chief Scientific Officer Paul Stoffels said Tuesday in an interview. From that point, the company will need one to two weeks to analyze the data and prepare documents for regulators in the U.S. and elsewhere, he said.

“We hope and trust that somewhere in March, we may get that approval,” Stoffels said.

The disconnect represents another potential blow to a U.S. immunization campaign that’s already failed to meet expectations. Inconsistent messaging and a patchwork of rules have led to long lines and clogged vaccination sites in some states, while others are struggling to deploy the shots they’ve received.

At current vaccination rates, the U.S. won’t hit 75% immunity -- the estimated level at which viral transmission will virtually halt -- until 2024, according to London-based consulting firm Airfinity Ltd. If President-elect Joe Biden’s administration is able to sufficiently ramp up vaccination rates to meet anticipated levels of production, herd immunity could be reached this August, Airfinity estimated.

Potential Shortfall

It’s still possible that J&J’s shot could gain emergency-use clearance by the end of February, if each part of the process -- from submission of an application to the convening of Food and Drug Administration advisers to evaluate trial data -- moves at a brisk pace, according to the company.

Operation Warp Speed, the U.S. effort to accelerate vaccine development and distribution, is banking on that faster timeline. Chief Scientific Adviser Moncef Slaoui said Tuesday that J&J’s vaccine could receive an authorization in mid-February. At that point, the U.S. expects to have doses numbering in the single-digit millions available from the company, he said.

That’s less than the 12 million doses that J&J agreed to supply by the end of February in a government contract. It includes 2 million doses that were to be delivered in January.

Slaoui said the U.S. is working with J&J to “get as close to a double-digit number as possible, and then a larger number in March and a much larger number in April.”

The New York Times reported earlier on the potential shortfall. Biden’s transition team declined to comment on reports of delayed J&J supplies.

Slaoui is resigning from Warp Speed and will stay on for 30 days to ensure a smooth transition, according to Biden’s transition team. Slaoui had earlier said that he would remain as a consultant to the program.

2021 on Track

Through 2021, J&J has committed to supplying 100 million immunizations worth $1 billion, or $10 each. The drugmaker remains on track to hit the goal of producing 1 billion doses before year-end, Stoffels said in the interview.

“We are still working to bring all the different plants on, because this is an unbelievably different volume than we’re used to,” he said, adding that production will ramp up throughout the year. “We’ll have to come out in the next few weeks with how much we can bring by quarter, or by month.”

It’s too early to discuss the specifics of J&J’s vaccine supply, spokesman Jake Sargent said. Data from its late-stage trial isn’t available, and the company hasn’t yet filed for clearance, he said.

“We are confident in our ability to meet our 2021 supply commitments signed with governments, and we expect to share more detail after some of these steps are achieved,” he said in a statement.

Distribution Delays

Delays in production, regulatory authorizations and administration are slowing the progress of immunization campaigns that the world is betting on to end pandemic-induced economic paralysis. After the Trump administration missed projections for doses of the Pfizer Inc.-BioNTech SE and Moderna Inc. vaccines administered last year, Biden’s team has committed to 100 million shots administered in the first 100 days of his term.

Holdups in releasing vaccine allocations could disrupt public health officials’ planning, said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials.

“There’s no predictability right now,” she said. “It’s extremely hard to message that publicly and also be on the ground, planning mass vaccination clinics and services when you really don’t know if your next shipment’s coming or not.”

Federal, state, and health-system coordination has been piecemeal, as stakeholders grapple with transporting, storing and administering vaccines, as well as disjointed messaging to the public.

While the U.S. is dependent on J&J’s doses, the limiting factor in immunizing the population “is not availability of doses but in fact the rate at which the U.S. is vaccinating,” said Matt Linley, an analyst at Airfinity.

J&J’s vaccine offers advantages in ease of distribution and administration. Health systems have been navigating relatively complex two-shot campaigns for vaccines from Pfizer and Moderna. J&J’s shot will likely protect people with a single dose, and can be stored at refrigerator temperatures for three months; the Pfizer and Moderna vaccines must be frozen.

Speaking Wednesday at a JPMorgan Healthcare Conference event, Slaoui said he expects the J&J shot to have 80% to 85% efficacy, surpassing the objective the company outlined in its clinical trial design.

“With pandemic implementation, a single dose is going to be so much more effective in the world,” Stoffels said.

©2021 Bloomberg L.P.

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