Sinovac secures emergency use permit for vaccine

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    The Sinovac COVID-19 vaccine. (Photo from sinovac.cn)

    THE private Chinese firm Sinovac Biotech secured an emergency use authorization (EUA) for its COVID-19 vaccine from the Food and Drug Administration yesterday, the eve of arrival of 600,000 doses donated by the Chinese government.

    FDA Director General Eric Domingo said benefits of using the Sinovac vaccine “outweigh the known and potential risks.”

    He said assessment on the Sinovac vaccine shows it has an efficacy rate of 65.3 percent to 91.2 percent for healthy individuals aged 18 to 59 years old.

    But it has a lower efficacy rate for healthcare workers constantly exposed to COVID-19 patients.

    “With a lower efficacy rate of 50.4 percent, it is not recommended for use in this group,” he said.

    Health workers and senior citizens are among the top priority sectors in government’s vaccination program.

    The Philippine Council for Health and Research Development said while the Sinovac vaccine is not recommended for healthcare workers due to its reported lower efficacy rate, they could still opt to get these shots rather than wait for other brands to arrive.

    PCHRD director Jaime Montoya said health workers are in the high-risk category due to their potential exposure to coronavirus carriers hence, a vaccine brand with higher efficacy is being eyed for them.

    However, where the supply reality is concerned, health care workers face a difficult choice: get Sinovac shots despite its 50.4 percent efficacy rate or hold out for higher-efficacy brands while risking reporting for duty without vaccine shots.

    Sinovac is the third to get an EUA, after the US firm Pfizer-BioNTech and the UK’s AstraZeneca, and likely the first to arrive and be used in the country.

    Two other vaccine makers — Russia’s Gamaleya Research Institute and India’s Bharat Biotech, have pending EUA applications.

    Domingo said additional information submitted by Gamaleya about phase 3 of its clinical trial is still being assessed by the FDA while Bharat has yet to submit studies sought by FDA experts.

    No other EUA application has been filed with the FDA, he said.

    Ambassador to Russia Carlos Soretta said the Philippines is now in the advanced stages of talks for the procurement of Sputnik V vaccines from Gamaleya.

    The government intends to buy 148 million doses of vaccines to inoculate 50 million to 70 million Filipinos this year.

    Health Secretary Francisco Duque III said the donated Sinovac vaccines are expected within the week.

    “Once there is already an EUA, the Chinese Embassy is asking for three to five days to prepare for the delivery of the 600,000 vaccine doses,” said Duque.

    Domingo said the Sinovac vaccine can cause mild to moderate adverse effects similar to common vaccine reactions.

    “No specific safety concerns have been identified. But it must be noted that this only reflects limited follow-ups and more adverse effects may emerge,” said Domingo.

    Duque said the Department of Health has placed an order of 50,000 Sinovac vaccine doses and will use the department’s savings for the purchase “as recommended by the National Task Force.”

    “This is aside from the 600,000 doses of Sinovac to be donated,” he said.

    Presidential spokesman Harry Roque said the first batch of vaccines from AstraZeneca, under the COVAX Facility, is expected to be shipped out in the last week of February.

    AstraZeneca and Pfizer have asked for an indemnity law, which government said contributed to the delay in the delivery of 117,000 doses of Pfizer vaccines.

    Roque said Sinovac did not ask for an indemnity agreement, adding that a P500-million indemnity fund is already being set up through a law.

    The indemnity agreement will give the the private firms immunity from suit, and will make government shoulder the cost of treatment in case of adverse effects from the vaccines.

    Roque also said 100,000 doses of the 600,000 doses donated by the Chinese government would be used on soldiers while the remaining 500,000 doses may be given to economic frontliners and the marginalized sector. He said the vaccination priority list may be amended in the Cabinet meeting on Monday night.

    Sinovac reported a 50.4 percent efficacy during trials in Brazil involving health workers and between 65.3 percent to 91.2 percent among healthy individuals who are aged between 18 to 59 years old.

    Roque said the Sinovac vaccine is not a low-quality vaccine, noting it has passed standards of the the World Health Organization.

    It would provide 50 percent protection against COVID-19 infection and 100 percent protection against death from COVID-19, while those who would still be infected would only get mild or asymptomatic cases, he said.

    Roque reiterated the President has not changed his mind about being inoculated with a China-made vaccine but he prefers Sinopharm.

    Members of Duterte’s close-in security were vaccinated last year with Sinopharm.

    Hong Kong’s leader Carrie Lam received China’s Sinovac vaccine yesterday, together with top officials, at a live televised event to bolster public confidence.

    VACCINES FOR OFWS

    The Department of Labor and Employment is looking to secure some 600,000 vaccine doses from the United Kingdom and Germany to inoculate departing overseas Filipino workers (OFWs).

    Alice Visperas, director of the International Labor Affairs Bureau, said Labor Secretary Silvestre Bello III has asked the two governments to donate COVID-19 vaccines.

    “Our estimate is there are more than 600,000 OFWs displaced. So the request is likely around that number,” she said.

    She said the donation would be in exchange for a possible grant of the request of the UK and Germany to be exempted from the cap in the deployment of Philippine healthcare workers.

    The Philippine Overseas Employment Administration imposed an annual 5,000 deployment cap for healthcare workers amid the COVID-19 pandemic.

    INDEMNIFICATION FUND

    The House of Representatives approved on second reading a Palace-backed bill which seeks to expedite the procurement and administration of COVID-19 vaccines and create a P500-million indemnification fund to compensate anyone who will develop serious side-effects.

    Through voice-voting, lawmakers adopted House Bill No. 8648 or “An Act Expediting the Procurement and Administration of Vaccines for the Protection Against the Coronavirus Disease 2019 (COVID-19).”

    Congressmen approved the measure after President Duterte certified it as urgent last week.

    The bill seeks to create the COVID-19 National Vaccine Indemnity Fund, which will be used to compensate anyone who was inoculated through COVID-19 vaccination program “in case of death, permanent disability, or hospitalization confinement.”

    “The amount of P500 million is hereby authorized to augment the funds of PhilHealth for this purpose which shall be sourced from the contingent fund as provided under Republic Act 11518 or the General Appropriations Act of 2021,” the bill said.

    The bill said any claim for indemnification for “serious adverse event directly arising from the administration of COVID-19 vaccine must be filed within five years from the day of inoculation.”

    Senate minority leader Franklin Drilon said the indemnification requirement “is borne out by the events that transpired in Dengvaxia controversy,” referring to the anti-dengue vaccine.

    He said the Dengvaxia case was mishandled by the Public Attorney’s Office which has filed numerous cases against vaccine maker Sanofi for deaths it linked to the anti-dengue vaccine.

    Vaccine czar Carlito Galvez has said that manufacturers are seeking an indemnity agreement because of the Dengvaxia issue.

    Meanwhile, Sen. Panfilo Lacson questioned the FDA’s grant of an EUA to Sinovac.

    “It’s like a chef who refuses to eat the food he just cooked because it is not good, but which he serves to the customers. How can a vaccinator convince the one that he is about to inoculate if he/she himself/herself is being discouraged by the government to use the Sinovac vaccine? This raises more questions and issues than what the National Task Force (NTF) Against COVID-19 is already busy grappling with,” he said.

    Meanwhile, some 70 percent of police personnel now want to be inoculated with COVID-19 vaccine, a seven percent improvement from last week, according to Lt. Gen. Guillermo Eleazar, PNP deputy chief for administration.

    Eleazar, concurrent commander of the PNP Administrative Support to COVID Operations Task Force, attributed the improvement to a continuing information drive on the importance of being vaccinated. — With Peter Tabingo, Jocelyn Montemayor, Raymond Africa, Wendell Vigilia and Victor Reyes