Johnson & Johnson’s unique vaccine against Covid-19 may not immediately alleviate widespread supply restrictions that are holding back the U.S. vaccination campaign. Still, it seems ready to help hard-to-reach populations that need protection from the virus.
This is the message from federal officials who are considering the best way to distribute the J&J feature once regulatory clearance is expected in the coming weeks. The J&J vaccine, which can be stored in the refrigerator, offers a logistical advantage over the Pfizer Inc. i Moderna Inc. two-shot vaccines currently in use and to be kept frozen. Still, it could take a while to change the pace of the campaign, a senior official said Monday.
J&J signed an agreement to supply the US with 100 million doses of a single vaccine by the end of June. Andy Slavitt, the Biden administration’s deputy coordinator for the pandemic response, said he would not be “overly confident that these doses would arrive evenly.” Instead, Slavitt said he expects most of the supply to be available by the end of that period.
In a final study of more than 43,000 people, the J&J vaccine prevented 66% of moderate to severe cases of Covid-19, the company announced Friday, which showed lower levels of efficacy than those developed by Pfizer and Modern. But the J&J shot was particularly effective at stopping the 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 regimens, and other requirements, U.S. officials will determine a pattern of distribution for them. It will be crucial to deliberate on the optimal use of each vaccine before adding another to the mix, said Matthew Hepburn, Covid-19 response manager for the U.S. government.
The J&J vaccine is poised to provide faster protection than its counterparts to people in communities where the virus spreads rapidly, as immunity rises immediately after a single shot, Hepburn said. This also portends places that seem vulnerable to new ones variants of the virus, he said.
The logistics facility of the J&J vaccine serves as a crucial tool for public health, Hepburn said. “Frankly, the simple is beautiful.”
Best shot
Anthony Fauci, the top U.S. head of infectious diseases, said Friday that federal authorities will talk to governors, mayors and others involved in planning the vaccination campaign to determine which vaccine to go for.
For example, in rural communities where authorities have been challenged by freezer requirements, the single dose of J&J may be more appropriate, Fauci said. If communities see fewer people returning for a second dose, a single vaccine could alleviate that problem, he added.
“There will be some local choice, 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 most from the J&J shot compared to other vaccines.
“States and localities should have flexibility, but local decisions are better when taken in light of uniform national guidelines,” said David Fleming, the medical and public health chief of PATH, a global health organization without profit.
Fleming, a public health expert and epidemiologist who has held positions at the Centers for Disease Control and Prevention and the The Bill & Melinda Gates Foundation agreed that the J&J vaccine will be particularly useful in rural communities. He also suggested that it would be a good option for people who cannot travel to health centers and pharmacies.
Presentation process
J&J received the results of its major final-stage clinical trial early last week. Although the company has not yet provided details to show vaccine performance in subpopulations, it said protection was consistent across ages, races and regions.
Now, J&J is preparing documents for U.S. and other regulators to apply for emergency use authorization. Scientific director 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 get a clearance in March.
Once the FDA receives the J&J submission, it must convene a group of external experts to review the data and make an independent recommendation. The CDC will organize its own meeting of external experts, known as the Advisory Committee on Immunization Practices, or ACIP, to provide guidance on how to better 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 three weeks later it was authorized for emergency use. Days later, the vaccine was first distributed.
Increased supply
To date, the United States has administered 31.8 million doses of Pfizer-BioNTech and Moderna vaccines, according to Bloomberg Vaccine Tracker, with an average of 1.35 million doses per day administered last week. Slavitt said there will probably be no “immediate dramatic change” when the J&J vaccine gets the green light from regulators.
Rather, the U.S. will see supply increase by late summer, he said. The government has formalized agreements with Pfizer and Moderna for a total of 400 million doses by the end of the second quarter. With J&J’s additional bid, there should be enough shots to inoculate 300 million people by the end of June.
Former Warp Speed leader, the Trump administration-led effort to develop and distribute vaccines, said he expects the J&J vaccine to have a broader scope than the other two vaccines so far.
“The fact that people get vaccinated with a single shot is transformative,” Moncef Slaoui, a former scientific adviser to Warp Speed, said in an interview.
– With the assistance of Josh Wingrove