Philippines OKs Sinovac COVID-19 vaccine for emergency use

23-Feb-2021 Intellasia | PhilStar | 7:17 AM Print This Post

The country’s Food and Drug Administration has granted an Emergency Use Authorisation 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 programme after the vaccines developed by AstraZeneca and Pfiser-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“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is granting an Emergency Use Authorisation to the COVID-19 vaccine of Sinovac,” FDA director general Eric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 authorisation 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 percent in clinical trials held in Indonesia and 91.25 percent in the study conducted in Turkey.

But late-stage trials in Brazil had shown an efficacy rate of 50.4 percentjust 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 Pfiser-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 percent effective on average. Meanwhile, COVID-19 jabs from Pfiser-BioNTech and Moderna reported 95 percent and 94.1 percent 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.

https://www.philstar.com/headlines/2021/02/22/2079599/philippines-oks-sinovac-covid-19-vaccine-emergency-use

 

 

Category: Philippines

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