FDA issues emergency use authorisation for Johnson & Johnson's single-dose covid vaccine

WASHINGTON, Feb 27: The FDA late on Saturday approved Emergency Use Authorisation (EUA) for Johnson & Johnson's single-dose covid vaccine as reported by IndiaTravelTimes.com on Friday.

It will be the third vaccine to be administered to the Americans after Pfizer and Moderna. J&J scores over all other covid vaccines produced in the world so far in that it requires only single dose and that it can be stored and transported under normal refrigeration temperatures while Pfizer and Moderna require ultra cold storage and transportation, besides two doses.

On Friday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) had met, deliberated and quickly and unanimously recommended to the FDA to issue emergency use authorisation (EUA) for the J&J vaccine.

In another of its pluses, J&J is also majorly claimed to inhibit asymptomatic infection, reducing the chances of transmission to a great extent, apart from preventing the disease in the inoculated. (But the FDA does not certify to this claim). There were also no reported cases of anaphylactic reactions following trial vaccination.

During the clinical trials, there were seven covid-related deaths in the placebo group while there were none in the vaccine group.

However, there were no sufficient trials to determine if the vaccine works in people over the age of 75. It hasn’t also been tested yet in children under the age of 18. (The FDA release excludes children under the age of 18, but does not exclude the elderly from vaccination).

The efficacy of the vaccine against moderate to severe covid across all geographic areas was 66.9% at least 14 days after the single-dose vaccination and 66.1% at least 28 days after vaccination.

"There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," according to the data submitted by Johnson & Johnson.

The vaccine is claimed to work against the virus variants. The variants, which are more contagious, are behind majority of cases in several countries like South Africa and the UK.

The vaccine has a 72% efficacy rate in the US and a more than 68% rate in Brazil in protecting people from mild to severe illness. It offered nearly 86% protection against severe illness in the US and nearly 82% in South Africa and nearly 88% in Brazil.

The voting in the Advisory Committee (VRBPAC) was unanimous. Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, head of the FDA's vaccine decision, had said EUA would come quickly.

However, after the EUA, the US Centers for Disease Control and Prevention too have to okay before the vaccination begins. Its Advisory Committee on Immunization Practices (ACIP) has scheduled a meeting for Sunday. It will vote on Sunday afternoon, and instruct the details on distribution and identify priority groups. Thereafter, the CDC director, Dr Rochelle Walensky, will give the final go-ahead.

The Government is ready with 4 million doses and can start inoculation immediately. It had ordered 100 million doses of the vaccine.

Meanwhile, Dr Anthony Fauci, top covid adviser and director of the National Institute of Allergy and Infectious Diseases, has said one should not try to pick and choose vaccines but take what comes first.

The FDA release said, "The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2."

However, significantly, it cautioned, "At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS- CoV-2 from person to person."