AstraZeneca OK’d for emergency use in PH

MANILA, Philippines — The Food and Drug Administration (FDA) has granted emergency use authorization to AstraZeneca PLC’s COVID-19 vaccine, the second to be approved in the Philippines.

AstraZeneca has been the vaccine of choice for numerous private businesses and local governments, which have signed agreements with the national government and the British-Swedish pharmaceutical company to buy 17 million doses of the vaccine, including a private sector agreement for 2.6 million doses.

FDA Director General Eric Domingo said the regulatory body granted emergency use authority to AstraZeneca after a thorough review of currently available data.

Benefits outweigh risks

The authorization is valid within the duration of the declared public health emergency due to COVID-19, or upon marketing authorization.

“It is decided that all conditions for [emergency use authorization] are present… and that the benefit of using the vaccine outweighs the known and potential risks,” Domingo said at a news briefing on Thursday.

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Such authorization is granted if it is reasonable to believe the vaccine may be effective to prevent COVID-19, if the benefits outweigh the risks, and there is no adequate, approved, and available alternative to the product for preventing or treating the severe respiratory disease.

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The FDA has previously approved Pfizer and BioNTech’s coronavirus vaccine. COVID-19 vaccines from Russia’s Gamaleya Research Institute, China’s Sinovac Biotech and India’s Bharat Biotech are awaiting approval.

Domingo said interim data from ongoing Phase 3 trials showed that the AstraZeneca vaccine was 70 percent effective after the first dose.

The vaccine regimen consists of two doses of .5 milliliters each given four to 12 weeks apart, he said.

The vaccine can only be given to people 18 years old and older, he said.

Adverse events from the AstraZeneca vaccine, he said, were “transient and mostly mild to moderate” and were similar to the reactions from other vaccines.

“No specific safety concerns were identified,” he said.

But he added that it was still possible for other adverse events to emerge later, that’s why those given the vaccines were being monitored.

No commercial distribution

Those to be vaccinated must be given fact sheets and must provide their written informed consent before being given the shots, Domingo said.

He stressed that the issuance of emergency use authorization did not mean the AstraZeneca vaccine could be marketed commercially.

It could only be supplied to emergency responders, such as the Department of Health (DOH), National Task Force Against COVID-19, or whoever the two organizations authorized to procure the vaccines, he said.

These could include hospitals, local governments, and private businesses.

The vaccines could be administered only by vaccinators accredited by the DOH.

If there is no agreement with the DOH or the task force, AstraZeneca will provide the cold chain requirements for the vaccine until these are delivered to the inoculation sites, Domingo said.

But the company could also share this responsibility with those procuring the vaccines, he added.

He also said there should be a system of monitoring to ensure the vaccines could be traced and kept consistent with manufacturing and logistical requirements.

The approval means the AstraZeneca vaccine can be used once it arrives in the Philippines, presidential spokesperson Harry Roque said.

From global pool

He said the Philippines would get AstraZeneca and Pfizer vaccines from COVAX—the global procurement pool co-led by the World Health Organization—and these were expected to arrive ahead of the Sinovac vaccine from China.

The Philippines expects to roll out its vaccination drive against COVID-19 next month.

Roque said the Philippines was not a laggard in inoculating its population against COVID-19.

Only a few countries have begun their vaccination drive, he said.

Meanwhile, epidemiologist Charles Yu, vice chancellor of De La Salle Medical and Health Sciences Institute, said people must support mass vaccination, and called on those reluctant to get vaccinated to consider the greater good.

People have a personal right to refuse to be vaccinated, but they must think of others as well, Yu said.

It is all right to refuse a vaccine only if there is no chance you will infect other people, he said.

“That personal right not to get a vaccine is trumped by the greater good. More people have to be vaccinated so that we can protect a greater number of people. If you are hesitant, just remember that this is not just for you, this is for your loved ones, this is for us to be able to return to normal,” he said.

Herd immunity

Herd immunity will only be achieved if the country is able to vaccinate a big proportion of the population, he said.

Yu noted that there have always been opponents of vaccination since vaccines have been discovered.

Vaccine confidence in the Philippines fell during the controversy over the Dengvaxia vaccine for dengue, which some blamed for the deaths of dengue patients, he said.

But vaccine confidence has since gone up through efforts of the DOH, he added.

The public, Yu said, should trust that available vaccines are safe and effective, as these went through stringent studies and processes before they were approved for use.

“The vaccine has been our greatest human triumph in defeating a lot of illnesses,” he added. —WITH A REPORT FROM REUTERS

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For more information on COVID-19, call the DOH Hotline: (02) 86517800 local 1149/1150.

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