Johnson & Johnson’s Covid-19 single-dose vaccine may not immediately ease the widespread supply restrictions that delay the US immunization campaign. Still, it seems ready to help hard-to-reach populations that need protection from the virus.
That is the message from federal officials who are struggling to find the best way to distribute the J&J shot as soon as they receive the regulatory clearance expected in the coming weeks. The J&J vaccine, which can be stored in a refrigerator, offers a logistical advantage over the Pfizer Inc. and Moderna Inc. two-dose vaccines currently in use that must be kept frozen. Still, it may take some time to change the pace of the campaign, a senior official said on Monday.
J&J struck a deal to supply the US with 100 million doses of the single injection vaccine by the end of June. Andy Slavitt, the Biden government’s deputy coordinator for responding to the pandemic, said he would not be “very confident that these doses would come evenly”. Instead, Slavitt said he expects most of the supply to be available by the end of that period.
In a final stage study of more than 43,000 people, the J&J vaccine prevented 66% of moderate to severe cases of Covid-19, the company announced on Friday, demonstrating lower levels of effectiveness than those developed by Pfizer and Modern. But the J&J injection was particularly effective in stopping serious illnesses, preventing 85% of serious infections and 100% of hospitalizations and deaths.
In view of the safety and efficacy profiles of the three vaccines, dosage regimens and other requirements, the American authorities will determine a distribution pattern for them. Deciding on the optimal use of each vaccine before adding another one to the mix will be crucial, said Matthew Hepburn, US government’s Covid-19 response leader.
The J&J vaccine is positioned to provide faster protection than its counterparts for people in communities where the virus is spreading rapidly, given that immunity increases immediately after a single injection, said Hepburn. This also bodes well for places that seem vulnerable to new variants of the virus, he said.
The logistical facility of the J&J vaccine serves as a crucial public health tool, said Hepburn. “Frankly, the simple is beautiful.”
Best shot
Anthony Fauci, the top infectious disease officer in the United States, said on Friday that federal officials will talk to governors, mayors and others involved in planning the immunization campaign to determine which vaccine should go where.
For example, in rural communities where authorities have been challenged by freezer requirements, a single dose of J&J may be more appropriate, said Fauci. If communities are seeing fewer people returning for a second dose, a single vaccine could alleviate this problem, he added.
“There will be some choice at the local level, depending on your needs,” said Fauci. “It is a very good problem to have.”
Public health experts want federal authorities to provide clear recommendations to states where communities will benefit most from the J&J injection compared to other vaccines.
“States and localities must have flexibility, but local decisions are best when they are made in the light of uniform national guidelines,” said David Fleming, chief physician and public health officer at PATH, a global nonprofit health organization.
Fleming, a public health specialist and epidemiologist who held positions at the Centers for Disease Control and Prevention and The Bill and 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 choice for people who cannot travel to health centers and pharmacies.
Submission Process
J&J received the results of its large final-stage clinical trial earlier this week. Although the company has not yet provided details to show how the vaccine worked in subpopulations, it said the protection was consistent across all ages, races and regions.
Now, J&J is preparing documents for regulators in the United States and elsewhere to seek an emergency use permit. Scientific director Paul Stoffels said in an interview that he expects J&J to contact the United States Food and Drug Administration by the end of the week and obtain authorization in March.
As soon as the FDA receives the J&J submission, it must assemble a panel 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 best 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 authorized for emergency use. Days later, the vaccine was distributed for the first time.
Increased supply
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 administered last week. Slavitt said there is unlikely to be an “immediate dramatic change” when the J&J vaccine gets the green light from regulators.
Instead, the United States will see supply increase in late summer, he said. The government closed deals with Pfizer and Moderna for a total of 400 million doses by the end of the second quarter. With the additional supply from J&J, there should be enough injections to inoculate 300 million people by the end of June.
The former leader of Operation Warp Speed, the effort led by the Trump administration to develop and distribute vaccines, said he expects the J&J vaccine to have a wider reach than the other two vaccines have so far.
“The fact that people will be vaccinated with just one injection, that is transformative,” said Moncef Slaoui, former chief scientific adviser to Warp Speed, in an interview.
– With the help of Josh Wingrove