Johnson & Johnson’s one-time Covid-19 vaccine will not immediately alleviate the widespread supply restrictions that slow the US immunization campaign. Still, it seems poised to help with hard-to-reach populations that need protection from the virus.
That’s the message from federal officials grappling with the best way to divide J & J’s shot once it gets regulatory approval in the coming weeks. The J&J vaccine, which can be kept in the refrigerator, offers a logistical advantage over the Pfizer Inc. and Moderna Inc. dual vaccines currently in use that must be frozen. Still, it may take time to change the pace of the campaign, a top official said Monday.
J&J has struck a deal to supply the US with 100 million doses of the single vaccine by the end of June. Andy Slavitt, the Biden administration’s deputy coordinator for pandemic response, said he would not be “too sure those doses would come evenly.” Instead, Slavitt said he expects most of the supply to be available by the end of that period.
In a late-stage study involving more than 43,000 people, J & J’s vaccine prevented 66% of moderate to severe cases of Covid-19, the company announced Friday, with lower efficacy than those developed by Pfizer and Moderna. But J & J’s injection was particularly effective in stopping serious illnesses, 85% of serious infections and 100% of hospitalizations and deaths.
Faced with the safety and efficacy profiles of the three vaccines, dosage regimens and other requirements, US officials will determine a pattern of distribution for them. It will be crucial to think about the optimal use of each vaccine before adding another to the mix, said Matthew Hepburn, the US government’s leader at Covid-19.
J & J’s vaccine is poised to provide faster protection than its counterparts to people in communities where the virus is spreading rapidly, as immunity rises immediately after a single shot, Hepburn said. That also bodes well for places that seem vulnerable to new virus variants, he said.
The logistical convenience of J & J’s vaccine serves as a critical public health tool, Hepburn said. “To be honest, simple is beautiful.”
Best shot
Anthony Fauci, the top infectious disease official in the US, said on Friday that federal authorities will talk to governors, mayors and others involved in planning the immunization campaign to determine which vaccine should go where.
In rural communities where authorities are challenged by the requirements for freezers, the single dose of J&J may be better suited, Fauci said. If communities see fewer people returning for a second dose, a single vaccine could alleviate that problem, he added.
“There will be somewhat of a choice at the local level, depending on your needs,” Fauci said. “That’s a very nice problem.”
Public health experts want federal authorities to make clear recommendations to states about which communities will benefit more from the J&J shot compared to the other vaccines.
“States and places need to be given flexibility, but local decisions are better when made in light of unified national guidelines,” said David Fleming, the chief medical and public health officer of PATH, a nonprofit global health organization.
Fleming, a public health expert and epidemiologist who has held positions with the Centers for Disease Control and Prevention and the Bill & Melinda Gates Foundation, agreed that J & J’s vaccine will be especially useful in rural communities. He also suggested it would be a good choice for those unable to travel to healthcare facilities and pharmacies.
Submission Process
J&J received results from its large late-stage clinical trial early last week. While the company has not yet to provide details to show how the vaccine performed in subpopulations, it said protection was consistent across ages, races and regions.
Now J&J is preparing documents that will allow regulators in the US and elsewhere to apply for a permit for emergency use. Chief Scientific Officer Paul Stoffels said in an interview that he expects J&J to approach the U.S. Food and Drug Administration by the end of the week and receive clearance in March.
Once the FDA receives J & J’s submission, it must convene a panel of outside experts to review the data and make an independent recommendation. The CDC will host 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, filed an application for its vaccine regimen on Nov. 20 and received emergency use clearance three weeks later. Days later, the vaccine was first distributed.
Stock boost
To date, the US 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 delivered last week. Slavitt said there is unlikely to be an “immediate dramatic shift” when J & J’s vaccine gets the green light from regulators.
Instead, the US will see supply increase by the end of the summer, he said. The government signed agreements with Pfizer and Moderna for a total of 400 million doses by the end of the second quarter. With J & J’s additional supply, there should be enough shots to inoculate 300 million people by the end of June.
The former leader of Operation Warp Speed, Trump’s government-led effort to develop and distribute vaccines, said he expects J & J’s vaccine to have a wider reach than the other two vaccines have so far.
“The fact that people are vaccinated with just one injection is transformational,” said Moncef Slaoui, former chief scientific advisor at Warp Speed, in an interview.
– With help from Josh Wingrove