HEALTH Secretary Francisco Duque III yesterday said the supply deal signed last week by government with AstraZeneca, which is developing a vaccine for the coronavirus disease (COVID-19), can be voided if the product fails to meet standards set by the Food and Drug Administration.
The Philippines signed the deal with AstraZeneca last week for the supply of 2.6 million doses of CVID-19 vaccines which are expected to arrive in the Philippines in May or June next year.
The deal was signed after some scientists raised doubts about the robustness of trial results showing the shot was 90 percent effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose.
Duque, in a briefing, said the agreement can voided “if there are any violations.”
“It is provided in the agreement that the vaccine needs to pass stringent evaluation analysis of the Vaccine Experts Panel (VEP) and the Food and Drug Administration. And AstraZeneca agreed to it,” he said.
“The agreement must adhere to the guidelines of the Department of Health because, in the end, the mandate of the government is to ensure that the vaccine is safe, of quality, effective, and practical to implement,” he added.
The Philippine Council for Health Research and Development (PCHRD) said AstraZeneca will have to get approval from the VEP before it can conduct clinical trials in the country.
“With regard to the recent news related to the effectivity of AstraZeneca’s vaccine, VEP is also waiting for official publications or data on the matter. We just have to wait,” PCHRD executive director Dr Jaime Montoya also said.
Aside from AstraZeneca, also having filed applications for the conduct of COVID-19 vaccine clinical trials in the country are Sinovac Biotech Ltd. of China, Janssen Pharmaceutica of Belgium, Gamaleya Research Institute of Russia, and Clover Biopharmaceuticals of China.
Aside from the Philippines, the UK government has also secured 100 million doses of the vaccine developed by AstraZeneca and Oxford University. Thailand has also signed a deal to procure 26 million doses.
Britain on Friday asked its regulator to assess AstraZeneca’s vaccine for a possible rollout. The UK government has targeted a rollout to begin before Christmas.
In the global race to develop vaccines against COVID-19, AstraZeneca’s candidate is viewed as offering one of the best hopes for many developing countries because of its cheaper price and ability to be transported at normal fridge temperatures.
AstraZeneca CEO Pascal Soriot said last week that the drugmaker was likely to run an additional global trial to assess the efficacy of its vaccine using the lower dosage.
The company had released trial data on Monday that showed its experimental vaccine prevented on average 70% of COVID-19 cases in late-stage trials in Britain and Brazil. – With Reuters