Philippines OKs Sinovac COVID-19 vaccine for emergency use
MANILA, Philippines (Updated 1:12 p.m.) — The country's Food and Drug Administration has granted an Emergency Use Authorization for the coronavirus vaccine developed by Chinese pharmaceutical firm Sinovac Biotech, its chief said Monday.
It is the third COVID-19 jab to get the approval needed for rollout in the government's inoculation program after the vaccines developed by AstraZeneca and Pfizer-BioNTech.
“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is granting an Emergency Use Authorization to the COVID-19 vaccine of Sinovac,” FDA Director General Eric Domingo said in a briefing Monday.
The announcement was made just a day before government officials said doses of Sinovac’s vaccine known as CoronaVac were supposed to arrive in the Philippines. Beijing committed to donate 600,000 doses of the Chinese-made coronavirus jab, of which 100,000 will be allocated to military personnel.
Health Secretary Francisco Duque III said Monday that the Chinese Embassy in Manila need three to five days to prepare the vaccine shipment once EUA is issued.
The EUA will be valid only within the duration of the declared public health emergency or upon the issuance of certificate of product registration, which is the typical license issued to products.
Not best vaccine for health workers
The authorization clears CoronaVac for use on “clinically healthy” individuals aged 18 and 59 years after it was found to have an efficacy rate of 65.3% in clinical trials held in Indonesia and 91.25% in the study conducted in Turkey.
But late-stage trials in Brazil had shown an efficacy rate of 50.4%—just above the threshold the World Health Organization uses to decide if a vaccine is worth using. Brazil conducted trials with healthcare workers exposed to COVID-19 patients only.
"The use of Sinovac vaccine on healthcare workers is not recommended," Domingo said, explaining that CoronaVac is not the most ideal vaccine to administer to medical frontliners because of their constant exposure to the virus.
Medical frontliners are at the top of the government's priority list for COVID-19 vaccination. Aside from them, senior citizens, indigent population and uniformed personnel are also among the priority groups.
“The safety profile is good, adverse events were mild to moderate. The possibility of allergy and severe allergy or anaphylaxis is minimal,” the FDA chief said in a mix of English and Filipino.
Unlike competitor vaccines from Pfizer-BioNTech, Moderna and AstraZeneca, Sinovac has yet to submit Phase 3 clinical trial data to medical journals for peer review.
The AstraZeneca shot was found to be 70% effective on average. Meanwhile, COVID-19 jabs from Pfizer-BioNTech and Moderna reported 95% and 94.1% efficacy rates, respectively.
Sinovac shots can be stored at around 2°C, which is the standard temperature that is within the existing cold chain system in the country.
The Philippine government earlier signed a term sheet with the Chinese drugmaker for 25 million doses of its vaccine.
It is aiming to secure a total of 146 to 148 million vaccine doses to inoculate at least 50 million people this year alone, but it has yet to execute definitive supply agreements with pharmaceutical companies. — with a report from Agence France-Presse
The national government has so far secured two official deals for COVID-19 vaccine supplies in the Philippines, one with Chinese pharmaceutical company Sinovac and another with the Serum Institute of India.
Watch this space for bite-sized developments on the vaccines in the Philippines. (Main image by Markus Spiske via Unsplash)
Health Officer-in-Charge Maria Rosario Vergeire says the general population may now get their second booster jab.
"We're just waiting for the release of implementing guidelines, then we'll start rolling out our second booster for the general population," she says. — Gaea Katreena Cabico
Amid questions on vaccines being administered, the Department of Health assures the public all doses are safe and effective as the “process of extending shelf life goes through thorough stability studies.”
“The government ensures that every vaccine that is injected with an extended shelf life has gone through studies, and is still safe and effective against COVID-19,” it adds.
Government must increase vaccination capacity across the Philippines in anticipation of a surge of COVID-19 cases caused by the Omicron variant of the corona virus, Sen. Risa Hontiveros says.
She says local government units and the private sector can work together to put up more vaccination centers and deploy more vaccination teams to get more people inoculated against COVID-19.
"The active COVID cases have nearly doubled in three days. The positivity rate is almost four times the ceiling set by the World Health Organization. Huwag na nating hintayin na sobrang lumala pa ang sitwasyon bago tayo gumawa ng paraan para mapabilis ang ating pagbabakuna."
FDA chief Eric Domingo says that its agency has given emergency approval for the use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.
The United States immunized around 900,000 children aged five-to-11 against Covid in the first week the Pfizer vaccine was authorized for them, a White House official says Wednesday.
Roughly 700,000 more have made appointments at pharmacies, White House Covid coordinator Jeff Zients tells reporters.
"The program is just getting up to full strength," he says, adding most of the shots were given in the last couple of days alone. — AFP
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