FDA OKs emergency use of Sinovac, says China-made vaccines not ideal for frontliners

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Metro Manila (CNN Philippines, February 22) — The country's Food and Drug Administration on Monday allowed the emergency use of COVID-19 vaccines manufactured by Chinese company Sinovac Biotech. FDA Director General Eric Domingo, however, cautioned that it is not the best vaccine in the market to protect healthcare workers in the frontlines of the COVID-19 pandemic.

The regulatory agency approved the emergency use authorization application of Sinovac after a long review due to incomplete submission of Phase 3 clinical trial data.

Domingo advised against giving the vaccine to frontliners who are constantly exposed to the virus, elderlies, and those with co-morbidities. He said the use of the Sinovac vaccine in healthcare workers is not recommended as it has a lower efficacy rate, adding it should only be received by healthy people aged 18-59 with an interval of four weeks between doses.

“Ang nakita kasi sa trial sa Brazil na binigay ito sa healthcare workers sa hospitals treating COVID-19 ay 50.4% ang efficacy niya. Mas mabuti na kaysa wala. Pero ang rekomendasyon natin, ng mga experts ay hindi ito ang pinaka magandang bakuna para sa kanila,” he said in a media briefing. "It has a lower efficacy rate of 50.4% when used on healthcare workers exposed to COVID-19. Therefore, it is not recommended for use in this group."

[Translation: The trial in Brazil showed that it was 50.4% effective on healthcare workers treating COVID-19 cases. This is better than no vaccine, but our recommendation and the recommendation of experts is that this is not the best vaccine for them.]

The vaccine developed by the Chinese company was found to be 50.38% effective in late-stage trials in Brazil, significantly lower than earlier published results. While the number exceeds the threshold required for regulatory approval, it falls far below the 78% previously announced.

Domingo said it showed 65.3% to 91.2% efficacy rate when used on healthy people within the recommended age range.

Despite the lower efficacy rate on healthcare workers, the FDA Chief said that Sinovac is a good option for those with allergies since there is a low possibility that a person will develop severe allergies or anaphylaxis after inoculation. He also said CoronaVac is halal-certified since it was tested in Indonesia.

Vaccine arrival, priority

Asked when the Sinovac vaccines are expected to arrive in the country, Senator Sonny Angara said in a Senate hearing that an initial batch of 1.5 million doses is set to be delivered "before the end of March."

The country's supply agreement totaling 25 million doses is expected to be signed in two weeks, Angara said, citing information from the National Task Force Against COVID-19 officials. Shipment will take place several days after the inking of the deal, which would mean vaccines will be available in the country by next month.

Apart from the vaccines the national government has procured, China has also donated 600,000 Sinovac doses to the Philippines. Health Secretary Francisco Duque III earlier in the day said the donated doses are ready to be shipped to the country since it was only awaiting regulatory approval. He said the Chinese Embassy requested for 3-5 days to prepare the shipment.

Since it is the first batch of vaccines expected to reach the Philippines legally, the priority list of recipients has to be revised due to the FDA restrictions. Healthcare workers, the elderly, and people with co-morbidities were supposed to receive the first doses, but with the restriction on the Sinovac vaccine, the list will be shaken up -– bumping up uniformed personnel.

Presidential spokesperson Harry Roque, who insisted the vaccine is not "low quality," said soldiers and economic frontliners may be the first ones to be inoculated in the country.

“Baka mauna ang economic frontliners na kasama ng sundalo, nagtatrabaho sa industriya na bukas noong ECQ. Kung hindi mabibigay sa seniors at frontliners, napakadami namang critical economic frontliners na mabibigyan.” he said in a separate briefing.

[Translation: Economic frontliners in industries open during ECQ and troops may be prioritized. If it cannot be given to senior citizens and frontliners, there are many critical economic frontliners who can receive it.]

China has allocated 100,000 doses of the total amount for Filipinos troops — in line with President Rodrigo Duterte's wish for soldiers and police personnel to be among the priority. Duterte has always made known his desire to have the police and the military included in the priority list as he said he needs "healthy" security forces.

Aside from China's donation, the Philippines has secured 25 million doses of CoronaVac. Duque said the Health Department will use its savings to purchase an initial 50,000 doses of the vaccines made by China.