FDA approves Janssen, Bharat vaccines for emergency use


THE Food and Drug Administration (FDA) has allowed the emergency use of the vaccines developed by Janssen Pharmaceuticals (Johnson & Johnson) and Bharat Biotech against coronavirus disease 2019 (Covid-19).

Both vaccine developers were issued an emergency use authorization (EUA) on April 19, according to a post by the Department of Health (DOH).

The Janssen vaccine, which was developed from a non-replicating viral vector, is given as a single dose to adults 18 years old and above, including the elderly and immunocompromised individuals.

No serious adverse events have been reported. Common complaints after inoculation were pain at the injection site, redness, swelling, tiredness, headache, muscle pain, chills, fever and nausea.

This vaccine may be stored at 2 to 8 degrees Celsius for three months.

Clinical trials conducted showed that this vaccine is around 77 percent effective in preventing severe Covid-19.

The Bharat vaccine, called Covaxin, was developed from an inactivated virus. It was administered in two doses 28 days apart to adults 18 to 98 years old during its phase 3 trials.

Serious adverse events that were reported were “not related to the vaccine and distributed equally among the placebo and vaccine groups.”

This vaccine may also be stored at 2 to 8 degrees Celsius.

The DOH said this vaccine was reported to be 80.6 percent effective against symptomatic Covid-19 after the second dose.

The FDA earlier approved the emergency use of the Pfizer, AstraZeneca and Sinovac vaccines in the country. An EUA does not allow commercial distribution of a vaccine.

As of April 11, the Philippines has received 3.025 million doses of Covid-19 vaccines, consisting of 2.5 million Sinovac and 525,600 AstraZeneca. (Marites Villamor-Ilano / SunStar Philippines)


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