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FDA allows use of Sinovac vaccine on senior citizens

After considering the recommendation of the vaccine experts, the Food and Drug Administration has allowed the use of Sinovac’s COVID-19 vaccine CoronaVac on senior citizens.

FDA Director General Eric Domingo said they took consideration of the current situation of “high Covid- 19 transmission and limited available vaccines.”

“Vaccination should be preceded by an evaluation of the person’s health status and exposure risk to assure that benefits of vaccination outweigh risks,” Domingo told the BusinessMirror.

The guidelines on the use of CoronaVac, he said, will be crafted by the Department of Health (DOH).

In a statement, the DOH said that the FDA has allowed the use of CoronaVac for senior citizens, “provided there is stringent evaluation of the person’s health status and exposure risk.”

“The decision to allow the use of the vaccine for seniors came about upon the recommendation of the Department of Science and Technology’s Vaccine Expert Panel, and considering the limited availability of vaccines and the growing need to protect seniors amid the increasing number of Covid-19 cases in the country,” the DOH said.

However, the DOH and FDA emphasized that the vaccination of senior citizens using CoronaVac should strictly be preceded by careful evaluation of the person’s health status and exposure risk. There is phase I/II safety and immunogenicity data for seniors but efficacy data is not yet sufficient to establish vaccine efficacy.

The DOH and FDA further stressed that while current efficacy data for senior citizens from Phase III trials is insufficient, the benefits of using the vaccine for this particular group outweigh its risks, and more scientific data on use for senior citizens may soon become available.

The country’s vaccine expert panel earlier recommended the use of Sinovac for the elderly.

Sinovac is only administered to people aged 18 to 59 because there was no available data provided for its clinical trials for elderly participants, although the FDA has been requesting for it.

Domingo, however, did not respond, when asked if the data that they were requesting were already given to the FDA.

Meanwhile, Health Undersecretary Maria Rosario Vergeire said the delivery of AstraZeneca vaccines from Covax Facility will be delayed.

“The doses will be delayed but they did not say it will take until the end of May,” Vergeire said in an online briefing.

Vaccine rollout

As of April 6, 2021, 2,670 vaccination sites are conducting Covid-19 vaccination in various sites across all regions.

Of the total available 2.5M doses, 1,936,600 (77 percent) doses have been distributed throughout the country, enabling the government to cover a larger portion of the population.

Of the distributed doses, a total of 922,898 doses have been administered to healthcare workers, senior citizens and persons with comorbidities, affording added protection to almost a million at-risk and vulnerable Filipinos.

Of the total allocated doses, 872,21 (63.74 percent) have been administered for the first dose, while 50,685 (3.70 percent) have been administered for the second dose.

“With the country experiencing a surge in the number of cases, the government continues to secure and distribute more doses, expedite vaccination, and expand coverage to protect more Filipinos. The National Task Force and the DOH assure the public that vaccination is free and calls on senior citizens and persons with comorbidities to receive the available vaccines and acquire the added protection it provides,” the DOH said.

Image credits: AP/Aaron Favila

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