One-shot J&J’s Covid vaccine gets WHO nod for emergency use

PT Jyothi Datta Updated - March 13, 2021 at 07:17 PM.

WHO panel reviewing AZ-Oxford vaccine, after reports of blood clots

FILE - This July 2020 photo provided by Johnson & Johnson shows a vial of the COVID-19 vaccine in Belgium. The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday, Feb. 27, 2021 cleared a Johnson & Johnson shot that works with just one dose instead of two.(Johnson & Johnson via AP, File)

The single-dose Covid-19 vaccine from Johnson & Johnson has been listed for emergency use by the World Health Organization (WHO), making it the third after Pfizer and AstraZeneca’s vaccines to get such an endorsement.

The WHO listing paves the way for a faster roll-out of the vaccine through its Covax facility and in countries that do not have a robust regulatory infrastructure to independently evaluate the vaccine or run independent trials.

The J&J vaccine is the first single-dose regimen to be listed, WHO chief Tedros Adhanom Ghebreyesus said at a briefing, even as he clarified on safety concerns around the AstraZeneca-OxfordUniversity vaccine, as countries in Europe including Denmark, Iceland, Norway and others temporarily suspended its use due to blood clots in those receiving the vaccine.

On the J&J vaccine, the WHO chief said, its Strategic Advisory Group on Immunization Experts would convene next week to outline recommendations on the use of this vaccine. The Covax facility has already booked 500 million doses of the vaccine, and expects to receive it “as soon as possible”

J&J has a tie-up with Hyderabad-based Biological E to make the vaccine. And it’s expected that the recent push from US President Biden’s administration during the Quad meet would hasten the regulatory process in bringing this vaccine to India.

The WHO emergency listing to J&J’s vaccine comes within days of the European Commission giving “Conditional marketing authorisation” to it for individuals of 18 years and above. And this in turn comes less than a fortnight after the US Food and Drug Administration gave the J&J vaccine an emergency use authorisation.

AZ vaccine concerns

On safety concerns involving the AZ vaccine, the WHO said it was aware that some countries had suspended the use of AZ vaccines, based on reports of blood clots in some people who received doses of the vaccine from two batches. “This measure was taken as a precaution while a full investigation is finalised,” Tedros.

Further, he pointed out, the European Medicines Agency had said there was no indication of a link between the vaccine and blood clots, and that the vaccine could continue to be used while its investigation was ongoing.

The WHO’s Global Advisory Committee on Vaccine Safety systematically reviews safety signals, he added, and they were assessing the current reports on the AZ vaccine.

“More than 335 million doses of Covid-19 vaccines have been administered globally so far, and no deaths have been found to have been caused by Covid-19 vaccines,”said Dr Tedros.

But “at least 2.6 million people have been killed by the virus. And more will continue to die the longer it takes to distribute vaccines as rapidly and as equitably as possible,”he added. Totally, almost 29 million doses of vaccines have been delivered to 38 countries, through Covax.

Globally, 335 million doses of vaccine have been administered in 144 economies. But 76 percent of those are in 10 countries, he pointed out. “The inequitable distribution of vaccines remains the biggest threat to ending the pandemic and driving a global recovery,”he said, calling for an increase in vaccine production.

Published on March 13, 2021 13:24