FDA allows emergency use of India, US vaccines

The Food and Drug Administration (FDA) has approved both the vaccines from Indian biotechnology company Bharat Biotech and a subsidiary of American pharmaceutical giant Johnson & Johnson for emergency use against Covid-19.

COVAXIN : India’s indigenously developed Covid-19 vaccine

FDA Director-General Rolando Enrique Domingo said the two-dose Covaxin from India and the JNJ-78436735 or Janssen single-dose vaccine of Janssen Pharmaceuticals have been given emergency use authorization (EUA).

Domingo added that the EUA issued to Bharat Biotech was a “conditional EUA” as the company needs to submit a certificate that would allow it to distribute the vaccine outside of their plant in India.

“They have inspected it, but they have not released the certificate and we will just have to submit that before importing the product, “ he said in English and Filipino at the Laging Handa briefing on Tuesday.

Indian Ambassador to the Philippines Shambhu Kumaran expressed his delight that the Covaxin vaccine has been given an EUA.

“Delighted that Covaxin has been granted EUA in the Philippines, Congratulations Bharat Biotech! [and] Thank you FDA Philippines!” Kumaran said.

Domingo said the Department of Health should issue additional guidelines on the use of the Janssen vaccine before its rollout after the United States FDA and Centers for Disease Control and Prevention issued a temporary pause on the vaccine over rare blood clots.

“There should be clear guidelines to inform both the vaccinator and vaccinee what to watch out for, what could be the symptoms, and if there are symptoms, where they will go and how will they be treated,” he added.

Despite these issues, the vaccine continues to have more benefits than risks of possible adverse events, Domingo said.

“Even if it’s found later to be connected to the vaccine, the 1 per 1 million adverse events, it is still important that we have protected 1 million people. We have to weigh the benefits compared to the risks,” he added.

Covaxin has an 81-percent efficacy in preventing Covid-19, according to interim data results, while JNJ-78436735 has a 66-percent overall efficacy, with 85-percent effectiveness against severe cases.

Domingo said other vaccine manufacturers have not submitted their requirements for EUA application, such as Sinopharm and Moderna.

Novavax is expected to apply for an EUA in the third quarter once its efficacy data on its vaccine is released.

8 million

The Philippines, through the private sector, expects to get 8 million doses of Covaxin in May or June, Presidential Adviser on Entrepreneurship Jose Maria “Joey” Concepcion 3rd said also on Tuesday after the FDA granted it an EUA.

“Covaxin is a very promising vaccine with an efficacy rate of 81 percent. It has also promised an early arrival this coming May and June which many companies are really wanting for them to inoculate immediately their employees,” Concepcion, also the founder of Go Negosyo, said in a statement.

Covaxin is India’s first indigenous vaccine and is endorsed by many health professionals and senior politicians from India, who took the vaccine along with their recommendations including Indian Prime Minister Narendra Modi.

At present, there are six vaccines that have EUAs in the Philippines — Pfizer, AstraZeneca, Sinovac, Gamaleya Institute, Johnson & Johnson and Bharat Biotech.

Concepcion said Go Negosyo’s “A Dose of Hope” vaccine program was working closely with many vaccine manufacturers and was supporting AstraZeneca, Moderna, Novavax and
Covaxin.

“We are facing a serious situation as the infection levels have dramatically accelerated due to the more transmissible variants [of Covid-19). Thus, we need to accelerate the arrivals of our vaccine purchases,” he added.

IP Biotech, the exclusive importer and distributor of Covaxin in the Philippines, and Ambica International Corp., the appointed consolidator, have held a series of meetings with Go Negosyo’s partners in the Philippines.

“The vaccine is our only way out in this pandemic, and it is only through our united action that we could achieve herd immunity. Attaining herd immunity, we can open further the economy and make lives and livelihoods flourish in the process,” Concepcion said.

WITH CATHERINE S. VALENTE