J&J just asked the US for emergency authorization of its COVID-19 vaccine, kicking off a process that could green-light its shot within weeks

Andrew Dunn
·4 min read
vaccine shot
A frontline healthcare worker receives a Moderna COVID-19 vaccination on January 5. Photo by William Campbell/Getty Images
  • A third coronavirus vaccine could be weeks away from reaching the American public.

  • Johnson & Johnson has submitted late-stage study results for its COVID-19 vaccine to US regulators.

  • An emergency OK could come before the end of February.

  • Visit the Business section of Insider for more stories.

Johnson & Johnson has asked US regulators to give an emergency OK to its experimental coronavirus vaccine, a step that could make the shot more widely available within weeks.

The healthcare giant has applied for emergency authorization from the Food and Drug Administration for the vaccine candidate, New Brunswick, New Jersey-based J&J said Thursday in a statement. Now FDA scientists and outside experts will scrutinize reams of data from J&J to determine whether the vaccine is safe and effective.

J&J's single-dose shot was 66% effective at preventing moderate and severe cases of COVID-19 in a global trial with more than 44,000 volunteers. If OK'd by regulators, the vaccine would be the third shot to reach the American public after the FDA authorized vaccines from Pfizer and Moderna in December.

Read more: What's coming next for COVID-19 vaccines? Here's the latest on 11 leading programs.

A one-dose jab should simplify the task of immunizing hundreds of millions of people. J&J's vaccine can be stored at typical refrigerator temperatures for several months, unlike the vaccine developed by Pfizer and BioNTech, which requires extremely cold storage.

J&J, the biggest healthcare company, hopes to produce 1 billion doses of its vaccine in 2021. The US government and J&J agreed in August to a $1 billion deal for 100 million doses to be delivered by the end of June. The healthcare giant has pledged not to sell doses for a profit during the pandemic.

So far, more than 27 million Americans have received at least one dose of a coronavirus vaccine, with states having received just over 55 million doses in total, according to February 3 data from the Centers for Disease Control and Prevention.

Details aren't available, making it difficult to compare J&J's vaccine with others

J&J has only described the data on its vaccine in a press release, making it difficult to compare it with rivals'. The top-line finding of 66% efficacy is lower than the two-dose vaccines from Moderna and Pfizer, which respectively demonstrated 94% and 95% effectiveness at preventing symptomatic COVID-19.

But comparing those numbers directly can be misleading, given how the trials were designed and the current state of the pandemic.

The late-stage trials testing the Pfizer and Moderna vaccines enrolled volunteers earlier on, when variants were not rapidly spreading. Certain variants have demonstrated the ability to diminish a vaccine's efficacy.

While there's no clinical evidence yet on how well vaccines from Pfizer and Moderna work against variants, some preliminary laboratory research against the B.1.351 variant, first identified in South Africa, showed Moderna's shot had more than a sixfold decrease in the level of neutralizing antibodies. While the biotech says it believes its vaccine is still effective against this strain, it has also started developing a variant-specific booster shot.

Read more: Top vaccine developers are upgrading COVID-19 shots as mutations threaten our progress in curbing the pandemic

Important unknowns linger over all the vaccine programs too. No vaccine developer knows how long vaccine protection will last, as follow-up time on volunteers has been limited. None of the studies were designed to figure out if the shots prevent asymptomatic transmission or viral shedding, meaning it's unclear if vaccinated people can still be infected and spread the virus to others.

J&J has said the jab is particularly effective at stopping infected people from winding up in the hospital or dying. The vaccine was about 85% effective at preventing severe illnesses, a result that held up across different age groups and - critically - geographies, Mathai Mammen, J&J's global research and development head, told Insider.

Geography matters because of the rise of coronavirus variants. J&J's study enrolled volunteers in South Africa and the UK, countries that have recently seen surging levels of new variants.

Specifics from J&J's study will be made public through the FDA review process. The agency is expected to convene a group of independent experts to vet the data in a daylong public meeting. A date has yet to be set for that critical meeting.

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