PH seeks AstraZeneca’s answers to issues raised over COVID-19 vaccine trial data

MANILA — Government has sought clarification from UK-based pharmaceutical firm AstraZeneca on questions raised about the conduct of clinical trials for its COVID-19 vaccine. 

This, as the Philippines, through the private sector, prepares to sign a deal to buy 2 million doses of AstraZeneca’s COVID-19 vaccine, which it said showed promising efficacy against the coronavirus. 

• READ: Philippines to sign deal to buy 2 million COVID-19 vaccine doses this week

International news outlets cited scientists questioning the company’s announcement that its vaccine has 90% efficacy even with a lower dose. Some expressed uncertainty of the results showing that the full dose given twice in a span of a month had an efficacy of 62%, which is still above the rate required by US regulators.

• READ: Questions over AstraZeneca's COVID-19 vaccine data risk delaying approval

Reports said a more important concern is the sub-group analysis because participant numbers are smaller. 

AstraZeneca’s sub-group that gave a 90% efficacy was only made up of 2,741 volunteers, compared trials by Pfizer and Moderna, which both tapped tens of thousands of participants in their trials that separately showed more than 90 percent effectivity for both vaccines. 

Health Undersecretary Maria Rosario Vergeire said during a briefing on Friday that they will have to see the official response of the company on such concerns. 

“We have to be officially informed by the manufacturer because they have that responsibility because they have been able to submit already their application to the country. Also, we have ongoing negotiations with them, it is but right that they are responsible to provide us with that adequate information as to these allegations regarding their study,” she said.

• READ: Philippines, private firms sign vaccine supply deal with AstraZeneca

The health official said the country’s vaccine experts and the Health Technology Assessment Council are requesting the same “so they can further study the implication of this.”

Despite this, Vergeire and a science official said “these are just numbers.”

“They were able to really implement their trial and the results are there. It’s just that the matter of the numbers and also the inclusion of other members of the population,” she said.

Dr. Jaime Montoya, Executive Director of the Department of Science and Technology- Philippine Council for Health Research and Development, said they also have no way of verifying the reports published by media “until [AstraZeneca] submits its official documents which we will have to verify based on the data they will present.”

“As I understand it they are presently evaluating and analyzing where the errors where and why this happened. But we do not foresee there is any effect on the efficacy. It’s just a question of numbers and the basis for such numbers,” he said.

However, he also said they “do not know why” a lower dose of the vaccine was measured to be more effective.

“So we still do not know why that is so. We have many theories. Even AstraZeneca has to look at the data. They are still looking at those numbers,” he said.

On the other hand, Montoya said the DOST welcomes the agreement between the Philippines and the British company for the purchase of 2 million vaccine doses. 

"It does not affect in any way the plan of AstraZeneca to conduct clinical trials in the Philippines,” he said, pointing out that it’s the only country in Southeast Asia participating in the company’s clinical trials.

Health officials explained before that clinical trials are important to see if the vaccines are also safe and effective for the Filipino population since vaccines may have different effects on different races.

Montoya said they are expecting AstraZeneca to also apply for emergency use in its host country and the Philippines once the government has its own emergency use authorization mechanism to speed up the approval process for COVID-19 vaccines.