PH allows emergency use of J&J, Covaxin Pfizer, CoronaVac, Sputnik V vaccines arriving this month

The Food and Drug Administration (FDA) is now allowing the emergency use of the single-dose Janssen vaccine of Johnson & Johnson and Covaxin of India’s Bharat Biotech in the country.

This brought to six the total number of coronavirus disease (COVID-19) vaccines that have been granted emergency use authorization (EUA) in the country, the FDA said on Tuesday, April 20.

Covaxin

FDA Director General Eric Domingo said Bharat Biotech initially applied for an EUA on January 22, and had submitted their clinical trial data on March 9.

“‘Yun po ang tinignan ng ating mga expert and they decided that the benefit of using this outweighs the risk (That’s what our experts evaluated and they decided that the benefit of using this outweighs the risk),” Domingo said.

He noted that the FDA granted Bharat Biotech a “conditional EUA” on April 19 as the firm has yet to submit another document before they could ship their vaccines to the country.

Foreign Affairs Secretary Teodoro Locsin Jr. on Tuesday thanked India following the grant of EUA to Covaxin.

“As if it’s a favor from us; the favor is to us,” the DFA secretary said in a tweet.

In a social media post on Monday, Indian Ambassador to the Philippines Shambhu Kumaran disclosed that the FDA has already given Covaxin a go signal for emergency use.

“Delighted that Covaxin has been granted EUA in the #Philippines. Congratulations #BharatBiotech! Thank you FDA Philippines,” the Indian diplomat said in a tweet.

In response, Locsin told the Indian envoy that the Philippines is instead indebted to India for saving the lives of many Filipinos and their loved ones who would now be vaccinated.

Based on preliminary data, Covaxin showed an efficacy rate of 81 percent following large-scale clinical trials that involved over 25,000 participants.

J&J’s Janssen

As for the Johnson & Johnson COVID-19 vaccines, Domingo said the pharmaceutical firm applied for emergency use on March 31 and was granted an EUA on April 19.

Secretary Carlito Galvez Jr., the country’s vaccine czar and chief implementer of the National Task Force (NTF) Against COVID-19, first

bared the grant of EUA to Johnson & Johnson durin the televised Cabinet meeting with President Duterte Monday night, April 19.

Domingo said that the food and drug regulatory agency in the United States is currently investigating possible adverse events of blood clotting potentially linked to Johnson & Johnson vaccine.

He hopes the Department of Health (DOH) would create a clear guideline before the rollout of the vaccine to inform vaccinators and the people what symptoms to watch out for, where they would seek treatment, and how they should be treated.

“But all in all, the benefit of using the vaccine in vaccinating 1 million people very definitely outweighs the risk of that possible clotting na wild for

every 1 million na maaari pong nangyari (that might occur),” Domingo said.

The EUA was granted to Johnson and and Johnson several days after the United States suspended the use of the Janssen jabs due to rare cases of blood clots developed by some of the vaccinees.

Last week, the US FDA and Center for Disease Control (CDC) said they have recommended the suspension of the distribution of J&J vaccines after they discovered that six patients developed blood clots after getting the said jab.

The six cases were reportedly a standout from the total of seven million people who were inoculated with the single-dose vaccine. (With reports from Roy C. Mabasa and Martin A. Sadongdong)