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Doubts on small trial may scuttle jab deal

Health Secretary Francisco Duque III said the agreement between the Philippine government, the private sector, and AstraZeneca may be deemed void if the drug maker’s vaccines will fail the FDA’s stringent review for safety and efficacy.

MJ Blancaflor

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British pharmaceutical firm AstraZeneca would not roll out its anti-COVID vaccine in the Philippines without an approval from the Food and Drug Administration (FDA), the Department of Health (DoH) said on Monday.

Doubts raised by some experts on the reported success rate of the drug is not also helping the quick rollout of the doses despite the Philippines being among the first in line to purchase the vaccine.

The Philippine private sector — funded by big companies — has placed an order of 2.6 million shots of a potential COVID-19 vaccine which are expected to be delivered in May next year.

The deal aims to inoculate just over a million Filipinos, or just one percent of the population, as the vaccine requires two doses per person.

Jose Concepcion, a government business adviser representing the private sector, earlier announced the purchase is meant to inoculate employees of several big companies.

Half of the purchase, meanwhile, will be donated to the government’s effort to have the medical frontline workers, the vulnerable and the poor sector vaccinated.

Former General Carlito Galvez Jr., the government’s vaccine czar, also disclosed that the government is also in the process of acquiring a million doses more to cover another 500,000 of the population.

In a televised briefing, Health Secretary Francisco Duque III said the agreement between the Philippine government, the private sector, and AstraZeneca may be deemed void if the drug maker’s vaccines will fail the FDA’s stringent review for safety and efficacy.

“It’s possible, because it means there was a violation of the agreement,” Duque said.

Last Friday, the Philippine government, the private sector, and executives from AstraZeneca signed the tripartite agreement for the 2.6 million doses of vaccines for the country.

Under the deal, some 30 private companies will shoulder the cost of coronavirus vaccines and with half donated to the government.

Jaime Montoya, executive director of the Department of Science and Technology’s (DoST) Council for Health Research and Development, said AstraZeneca also signed an agreement allowing the country’s vaccine experts panel to review the results of the firm’s previous clinical trials.

“What we have to do right now is we have to wait for the official publication of the data that we have been talking about. For now, the vaccine panel is basing their evaluation on the documents submitted to them by AstraZeneca,” Montoya said.

AstraZeneca and its partner, the University of Oxford, had been accused of cherry picking its data from the clinical trial of its potential COVID-19 vaccine to supposedly show a high efficacy rate.

The firm previously announced that its vaccine showed a 70 percent efficacy rate on average. The rate jumped to 90 percent when an initial half-dose, then a full dose was given, similar to those being developed by American company Moderna, as well as Pfizer and its German partner BioNTech.

American scientists pointed out that the higher efficacy rate of AstraZeneca’s vaccine came from a smaller trial consisting of people aged 55 and below.

In response to criticisms, AstraZeneca chief executive Pascal Soriot told Bloomberg that further research is needed to ensure the efficacy of its coronavirus vaccine.

AstraZeneca is one of the five drug makers which expressed interest to conduct Phase 3 clinical trials of their COVID-19 vaccines in the Philippines.

Chinese firms Sinovac Biotech and Clover Biopharmaceuticals have previously passed the evaluation of the country’s vaccine expert panel. These firms are now seeking the approval of the ethics review committee and the FDA.

The other firms that applied to conduct late-stage trials here are Russia’s Gamaleya Research Institute and Belgium-based Janssen Pharmaceuticals.

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