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Johnson & Johnson’s one-shot Covid-19 vaccine may not immediately alleviate widespread supply constraints that are slowing the vaccination campaign in the United States. Still, it appears poised to help hard-to-reach populations who need protection from the virus.
That’s the message from federal officials wondering how best to distribute J & J’s shot once it gets the regulatory clearance expected in the coming weeks. The J&J vaccine, which can be stored in the refrigerator, offers a logistical advantage over the Pfizer Inc. and Currently in use Moderna Inc. two-dose vaccines that should be stored frozen. Still, it could take some time to change the pace of the campaign, a senior official said on Monday.
J&J has reached an agreement to deliver 100 million doses of the single-injection vaccine to the United States by the end of June. Andy Slavitt, the Biden administration’s deputy coordinator for the pandemic response, said he would not be “too confident that these doses would be evenly distributed.” Instead, Slavitt said he expects most of the supply to be available towards the end of this period.
In an advanced-stage study involving more than 43,000 people, J & J’s vaccine prevented 66% of moderate to severe cases of Covid-19, the company said on Friday, demonstrating lower efficacy levels than those developed by Pfizer and Moderna. But J & J’s shot was particularly effective in stopping serious illness, preventing 85% of serious infections and 100% of hospitalizations and deaths.
Faced with the safety and efficacy profiles of the three vaccines, dosing schedules and other requirements, U.S. officials will determine a distribution pattern for them. It will be crucial to deliberate on the optimal use of each vaccine before adding another to the mix, said Matthew Hepburn, the U.S. government’s Covid-19 response officer.
J & J’s vaccine is poised to provide faster protection than its counterparts to people living in communities where the virus spreads rapidly, given that immunity rises immediately after a single stroke, Hepburn said. It also bodes well for places that seem vulnerable to new variants of the virus, he said.
J & J’s vaccine logistics facility serves as a crucial public health tool, Hepburn said. “Frankly, simple is beautiful.”
Best shot
Anthony Fauci, the top U.S. infectious disease official, said on Friday that federal officials will be speaking with governors, mayors and others involved in planning the vaccination campaign to determine which vaccine should go where.
For example, in rural communities where authorities have been challenged by freezer requirements, the single dose of J&J may be better suited, Fauci said. If communities see fewer people coming back for a second dose, a one-shot vaccine could alleviate this problem, he added.
“There will be some choice locally, depending on your needs,” Fauci said. “It’s a very nice problem to have.”
Public health experts want federal authorities to provide clear recommendations to states on which communities will benefit the most from the J&J vaccine compared to other vaccines.
“States and localities should have flexibility, but local decisions are best made in light of uniform national guidelines,” said David Fleming, chief medical officer and medical officer of health for PATH, a global organization. health nonprofit.
Fleming, a public health expert and epidemiologist who has served in the Centers for Disease Control and Prevention and the The Bill and Melinda Gates Foundation, agreed that J & J’s vaccine will be particularly useful in rural communities. He also suggested it would be a good choice for people who can’t get to healthcare facilities and pharmacies.
Submission process
J&J received the results of its large, advanced clinical trial early last week. While the company has yet to provide details to show how the vaccine performs in subpopulations, it said protection is consistent across ages, races and regions.
Now, J&J is preparing documents for regulators in the United States and elsewhere to apply for emergency use authorization. Scientific director Paul Stoffels said in an interview that he expects J&J to approach the US Food and Drug Administration by the end of the week and get clearance in March.
Once the FDA receives J&J’s submission, it must convene a panel of external experts to review the data and make an independent recommendation. The CDC will organize its own meeting of outside experts, known as the Advisory Committee on Immunization Practices, or ACIP, to provide advice on how best to allocate the vaccine and prioritize certain populations.
Together, these processes can take weeks. Pfizer and its partner BioNTech SE, for example, submitted an application for its vaccine regimen on November 20, and three weeks later it was cleared for emergency use. A few days later, the vaccine was distributed for the first time.
Supply boost
To date, the United States has administered 31.8 million doses of the Pfizer-BioNTech and Moderna vaccines, according to Bloomberg’s Vaccine Tracker, with an average of 1.35 million doses per day administered last week. Slavitt said there likely won’t be an “immediate dramatic change” when J & J’s vaccine receives the green light from regulators.
On the contrary, the United States will see supply increase towards the end of the summer, he said. The government has reached deals with Pfizer and Moderna for a total of 400 million doses by the end of the second quarter. With the additional supply of J&J, there should be enough vaccine to immunize 300 million people by the end of June.
Former head of Operation Warp Speed, the Trump administration-led effort to develop and distribute vaccines, said he expects J & J’s vaccine to be broader in scope than the two other vaccines so far.
“The fact that people are vaccinated with just one vaccine is transformational,” said Moncef Slaoui, former chief scientific adviser to Warp Speed, in an interview.
– With help from Josh Wingrove
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