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.
FDA Director-General Rolando Biotech! [and] Thank you FDA Enrique Domingo said the twodose Philippines!” Kumaran said. Covaxin from India and the Domingo said the Department JNJ-78436735 or Janssen singledose of Health should issue additional vaccine of Janssen Pharmaceuticals guidelines on the use of the Janssen have been given emergency vaccine before its rollout after use authorization (EUA). the United States FDA and Centers
Domingo added that the EUA for Disease Control and Prevention issued to Bharat Biotech was a issued a temporary pause on “conditional EUA” as the company the vaccine over rare blood clots. needs to submit a certificate that “There should be clear guidelines would allow it to distribute the vaccine to inform both the vaccinator outside of their plant in India. and vaccinee what to watch out
“They have inspected it, but they for, what could be the symptoms, have not released the certificate and if there are symptoms, where and we will just have to submit they will go and how will they be that before importing the product, treated,” he added.
“he said in English and Filipino Despite these issues, the vaccine at the Laging Handa briefing on continues to have more benefits Tuesday. than risks of possible adverse
Indian Ambassador to the Philippines events, Domingo said. Shambhu Kumaran expressed “Even if it’s found later to be his delight that the Covaxin vaccine connected to the vaccine, the 1 has been given an EUA. per 1 million adverse events, it is
“Delighted that Covaxin has still important that we have protected been granted EUA in the Philippines, 1 million people. We have Congratulations Bharat 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.