Johnson & Johnson’s single – shot Covid-19 vaccine may not immediately alleviate the widespread supply restrictions, which is delaying the US vaccination campaign. After all, it seems that it is difficult to help populations that need to be protected from the virus.
This is the message from federal officials wrestling with the best way to disperse J & J’s shot once regulatory approval is 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-stroke vaccines currently in use should be kept frozen. It may still take a while to change the pace of the campaign, a top official said on Monday.
J&J has reached an agreement to supply the US with 100 million doses of single vaccine by the end of June. Andy Slavitt, the deputy coordinator of the Biden administration for pandemic response, said he would not be “too confident that the doses would come evenly.” Instead, Slavitt said he expects most of the supply would be available by the end of the period.
In a late-stage study involving more than 43,000 people, J & J’s vaccine prevented 66% of the moderate to severe cases of Covid-19, the company announced on Friday, showing lower efficiencies than those developed by Pfizer and Moderna. . But the shot of J&J was especially effective in stopping serious illnesses, 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, US officials will determine a distribution pattern for them. Considering the optimal use of each vaccine before adding another to the mixture is crucial, said Matthew Hepburn, the leader of the U.S. government, Covid-19.
The J&J vaccination is intended to provide faster protection than their peers to people in communities where the virus spreads rapidly, as immunity increases immediately after a single shot, Hepburn said. It also offers good interests for places that look defenseless virus variants, he said.
The logistical convenience of vaccinating J&J serves as an important tool for public health, Hepburn said. “Honestly, simple is beautiful.”
Best shot
Anthony Fauci, the leading U.S. official for infectious diseases, said Friday that federal authorities will talk to governors, mayors and others involved in planning the vaccination campaign to determine which vaccine should go where.
In rural communities where authorities are challenged by the freezing requirements, J & J’s single dose may be more appropriate, Fauci said. If communities see fewer people returning for a second dose, a one-vaccine could alleviate the problem, he added.
“There will be some choice at the local level, depending on your needs,” Fauci said. “This is a very good problem.”
Public health experts want federal authorities to give clear recommendations to states on which communities will benefit more from the J&J shot compared to the other vaccines.
“States and localities need to be flexible, but local decisions are better when taken in the light of uniform national guidelines,” said David Fleming, chief medical officer and public health officer at PATH, a nonprofit global health organization.
Fleming, a public health expert and epidemiologist who has held roles at the Centers for Disease Control and Prevention and the Bill & Melinda Gates Foundation, agrees that J & J’s vaccine will be particularly useful in rural communities. He also suggested that it would be a good choice for people who cannot travel to healthcare facilities and pharmacies.
Submission process
J&J received results from its large late-stage clinical trial early last week. Although the company has yet to provide details to show how the vaccine performs in subpopulations, protection is consistent across all ages, breeds and regions.
J&J is now preparing documents for regulators in the US and elsewhere to obtain an emergency use permit. The scientific officer, 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 receive a clearance in March.
Once the FDA receives the submission from J&J, it must convene a panel of outside experts to review the data and make an independent recommendation. The CDC is organizing its own meeting of outside experts, known as the Advisory Committee on Immunization Practices, or ACIP, to provide guidance on how to best administer the vaccine and prioritize certain populations.
Together, these processes can take weeks. Pfizer and its partner For example, BioNTech SE submitted an application for its vaccine regimen on November 20, and three weeks later it was approved for emergency use. Days later, the vaccine was first distributed.
Provide Boost
According to Bloomberg’s Vaccine Tracker, the US has so far administered 31.8 million doses of Pfizer-BioNTech and Moderna vaccines, with an average of 1.35 million doses per day administered last week. Slavitt said there would probably be no “immediate dramatic shift” when J & J’s vaccine gets the green light from regulators.
On the contrary, the US will see supply increase by the end of the summer, he said. By the end of the second quarter, the government had concluded a total of 400 million doses of Pfizer and Moderna. With the extra offer from J&J, there should be enough shots by June to vaccinate 300 million people.
The former leader of Operation Warp Speed, the Trump administration’s 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 will be vaccinated with just one shot is transformation,” Monpf Slaoui, former scientific adviser to Warp Speed, said in an interview.
– With help by Josh Wingrove