News Release

FDA to complete evaluation of J&J’s COVID-19 vaccine this week

The Food and Drug Administration (FDA) expects to complete its evaluation of Johnson & Johnson’s Janssen COVID-19 vaccine within this week following its application for an emergency use authorization (EUA), the FDA chief said on Monday.

Reporting to President Rodrigo Duterte during the President’s Talk to the People, FDA head Eric Domingo said Janssen’s single dose vaccine already has EUA in the US, Europe, Canada, Switzerland, and also secured the World Health Organization’s (WHO) emergency use listing.

In the case of China’s Sinopharm, Domingo said somebody sent them a letter conveying the drugmaker’s intention to apply for an EUA but it is yet to comply the requirements of the FDA.

America’s Moderna, on the other hand, is still completing its documents and its local partner will submit them hopefully this week, according to Domingo.

“Iyong Moderna mayroon na rin po ‘yang EUA sa US at saka sa European Union so hindi naman po tayo matatagalan sa pag-evaluate po niyan. Medyo nagbabasa-basa na nga po tayo, ‘yong ating mga evaluators kahit wala pa pong submission,” he told the President.

Domingo also said they expect Novavax to apply after the second quarter. There is still no EUA issued on Novavax elsewhere and it appears that the drugmaker will apply in May or June.

In the Philippines, the company may possibly apply for an EUA towards the later part of the year, the FDA head said.

Pharmaceutical companies which were granted EUA include Pfizer Inc., AstraZeneca, Sinovac, and Gamaleya Research Institute. A fifth drugmaker, Bharat Biotech from India has a pending application.

Domingo also reported on the supply the COVID-19 therapeutic drugs. Because of the surge in cases, there is difficulty in the distribution of Remdesivir in hospitals.

But Domingo said suppliers have made an assurance that there is availability of stocks for at least one month and importations are ongoing. Hospitals secure compassionate special permit from the FDA for Remdesivir so that they could administer the drug to their patients.

In the case of Avigan, Domingo said there is enough supply of the drug, which is usually given to mild and moderate COVID-19 cases. Hospitals also has to apply for compassionate special permit for Avigan since the drug is not yet fully registered in the Philippines.

Tocilizumab, another therapeutic drug, is in short supply this week because there is only one manufacturer and supplier for the drug, according to Domingo.

“It’s a patented drug at although ang magandang balita naman po, kanina nag-email na po ‘yong supplier nito at may padating na po daw sila na 5,000 doses sa Pilipinas this week so this will be distributed to the hospitals. This is a registered drug so wala pong problema ito. Mayroon po itong CPR,” he said.

Also in his report, Domingo said Ivermectin is not yet included in the treatment protocol being followed by Department of Health (DOH) as well as by the Infectious disease specialists.

Although the drug is approved for animal use, Domingo said three companies signified their intention to register Ivermectin so that it could be administered to humans.

“Binigyan na po namin sila ng listahan ng requirements at basta naman po sila mag-submit eh ie-evaluate naman po agad ito ng FDA,” he said. PND