COVID-19 vaccine developer AstraZeneca has withdrawn its application to conduct Phase 3 clinical trials in the Philippines, the Food and Drug Administration (FDA) confirmed on Friday, December 11.
“They said they already have enough data,” FDA Director General Eric Domingo said in a message to Rappler.
Asked when the company stopped its application, Domingo said his staff informed of him of the development today.
AstraZeneca’s decision to withdraw its application comes just days after it secured the endorsement of the Philippines’ research ethics board, one of the requirements needed to conduct trials in the country.
Last December 4, Dr Nina Gloriani, head of the Philippines’ vaccine expert panel, said the group was waiting for the company to respond to its comments before it decided whether to endorse its application to the FDA.
AstraZeneca, which developed its vaccine with the University of Oxford, became the first COVID-19 vaccine candidate to have efficacy results from phase 3 trials published in peer-reviewed journal The Lancet. Its study published earlier this week confirmed initial trial data that showed their vaccine was 70% effective in protecting against symptomatic COVID-19.
While the company pulled out is application, Domingo earlier said conducting Phase 3 clinical trials in the Philippines is not a prerequisite for a vaccine to be registered for use in the country.
The Philippines has so far secured from the company an initial 2.6 million doses for about 1.5 million Filipinos through an agreement with the Philippine government and private sector. The doses will be split in half between the government and businesses that chipped in for the P700-million deal.
On top of this, Galvez said the firm would be setting aside 20 million doses for the Philippines, each priced at “more or less $5.”
This leaves at least 4 companies with applications for Phase 3 trials in the country – China’s Sinovac, Russia’s Gamaleya Research Institute, Clover Biopharmaceuticals, and Johnson & Johnson’s (Janssen Pharmaceuticals).
Like AstraZeneca, vaccine developer Sinopharm decided last October that it would no longer conduct Phase 3 trials in the Philippines. – Rappler.com