Johnson & Johnson Sends New Vaccine to FDA For Approval

The American Food and Drug Administration will begin to review the Johnson & Johnson vaccine, which the company states is 100% effective at preventing hospitalizations and deaths from Covid-19, on February 26.

The Johnson & Johnson product — in contrast to the two vaccines already used in the US to fight Covid — does not require ultracold temperatures for preservation but just regular refrigeration. Another major plus of the new vaccine candidate is that the inoculation requires only one shot, instead of two, as is true for all the vaccines currently in use.

28 million Americans already inoculated

Currently, almost 28 million Americans have been inoculated against the coronavirus, using either the Pfizer/BioNTech or Moderna products.

The FDA stated that, as per usual procedures, a panel of independent experts will review the vaccine. The process will begin on February 26, making it possible that the Johnson & Johnson inoculation would be available in March if approved.

The New Brunswick, New Jersey- based pharmaceuticals firm announced the efficacy and safety data from the Phase 3 clinical trial for the new product on Thursday evening, which they said demonstrated that the investigational single-dose Covid-19 vaccine in development at its Janssen Pharmaceutical Companies subsidiary met all primary and key secondary endpoints.

85% effective against most severe symptoms

The safety and efficacy data from the trials is based on 43,783 participants, who experienced 468 symptomatic cases of Covid-19.

The Phase 3 study, according to Johnson & Johnson, was designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting “moderate to severe” Covid-19.

Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s Covid-19 vaccine candidate was 66% effective overall in preventing moderate to severe Covid-19, 28 days after vaccination.

The onset of protection was observed as early as the fourteenth day after the first inoculation. The level of protection against moderate to severe Covid-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days aftervaccination.

It didn’t appear quite as strong as the two-dose competitors made by Pfizer and Moderna — but this may be misleading due to differences in the testing protocols. The Johnson & Johnson product was 85% protective against the most serious symptoms of Covid-19.

“We can’t ignore any tool in the toolchest”

In addition, beginning 28 days after their shot, researchers discovered that not one trial participant who had recieved the vaccine needed hospitalization or died from Covid-19.

The FDA will now ask its independent panel to publicly review all the data related to the single-dose shot before it decides whether to give the tumbs-up to a third vaccine option in the United States.

CNN reported that the head of the FDA, Dr. Peter Marks, has cautioned the public, so eager to have another vaccine in the pipeline against the dreaded virus, to avoid making comparisons between all the vaccines before the evidence is presented.

Marks told the American Medical Association last week “With so much need to get this pandemic under control, I think we can’t ignore any tool in the tool chest. We will have to do our best to try to make sure that we find the populations that benefit the most from each of these vaccines and deploy them in a very thoughtful manner.”

“Not a game-changer– it’s a different game altogether”

Dr. Nirav Shah, the prominent epidemiologist who is the head of the Maine Center for Disease Control, stated in a press briefing on Tuesday that the J & J vaccine “differs in material ways relative to the two candidates that we have right now from Pfizer and Moderna.

“Namely, it’s one dose and it’s a lot more portable,” due to the fact that it does not have the stringent requirements of the current vaccines, Shah stated. “If that vaccine is authorized and made available to states in sufficient quantities, it opens up a brand-new front for us,” he declared.

“It means that vaccine can be distributed much more easily, it can be kept outside that frozen environment for a longer period of time and we can focus in on a population” without having to worry about how those individuals will receive a second dose, he explained.

That could mean bringing inoculation to a “brand-new and different population in some respects than the population in the venues we’re using right now.

“That’s not a game-changer — it’s a brand new, different game altogether.”

Johnson & Johnson announced that @JanssenGlobal has submitted an application to the @US_FDA requesting Emergency Use Authorization of its investigational single-dose #COVID19 vaccine candidate. Read more: https://t.co/Yx4P5Rk16P pic.twitter.com/e9P0NaiGAB

— Johnson & Johnson (@JNJNews) February 4, 2021