Game changer jab gets green light

Another vaccine in the US has been given emergency authorisation as the nation battles to stem its coronavirus tidal wave. This one takes just one shot.

The US Food and Drug Administration has announced that it has issued an emergency use authorisation for the Johnson & Johnson COVID-19 vaccine, the third overall.

“The authorisation of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Dr Janet Woodcock.

“The FDA, through our open and transparent scientific review process, has now authorised three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorisation.”

The FDA said tests on the Janssen Biotech Inc. vaccine showed it was about 67 per cent effective in preventing moderate to severe cases within 14 days after dosing and 66 per cent effective against severe to critical cases after 28 days.

Unlike the previous vaccines, which are more effective, it takes just one shot.

Janssen is a pharmaceutical subsidiary of Johnson & Johnson.

The jab is derived from an adenovirus vector formula, unlike the vaccines created by Moderna and Pfizer-BioNTech which were created using mRNA technology and have already seen emergency use approval.

This one was found to have a “favourable safety profile with no specific concerns identified that would preclude issuance of an EUA,” the FDA said in documents posted earlier this week.

Recipients of an emergency use authorisation are required to file safety reports and inform the FDA of any serious issues, side effects, hospitalisation or deaths as a result of their product.

The FDA based its decision on a study of the Janssen vaccine on more than 39,000 people in multiple countries, including the US.

Roughly half were given a placebo. The others showed that the vaccine is effective roughly two-thirds of the time.

The Pfizer and Moderna vaccines, which both require two doses, are 95 per cent and 94.1 per cent effective, respectively.

But the Johnson & Johnson single-dose vaccine is also easier to store and has a longer shelf life at higher temperatures.

This article originally appeared on Fox News and was republished with permission

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