FDA: More info needed on Sinovac vaccine

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    JUST two days before the expected arrival of its COVID-19 vaccines, the private Chinese firm Sinovac has yet to get an emergency use authorization (EUA) from the Philippine Food and Drug Administration.

    FDA Director General Eric Domingo defended the non-issuance of the EUA, saying the agency is taking “extra care” to avoid potential problems with the vaccines donated by the Chinese government.

    “We don’t want to have problems later on when the product is already here and are allowed to be used,” said Domingo.

    Sinovac filed an application for EUA on January 13.

    The FDA last month granted EUAs to the US firm Pfizer and UK’s AstraZeneca. Domingo said the FDA needs additional information from Sinovac because of the absence of published data in a medical journal.

    “We are still asking for some clarification on their findings in their studies. We cannot overlook these data and forego analysis,” said Domingo.

    “This is especially true with Sinovac as they have not published their data peer reviewed journal so we need to complete the evaluation,” he added.

    The Chinese government is donating 600,000 doses of Sinovac vaccines, with the arrival scheduled on February 23.

    Presidential spokesman Harry Roque last week said the arrival of the donation may be delayed because Sinovac wants to wait for the EUA before sending the vaccines.
    Domingo also said another vaccine, the US firm Moderna, has expressed intent to file for an EUA in the Philippines.

    “They said they are just completing the applications and that they will file soon,” said Domingo.

    He also said he believes that it will not take long for Moderna to secure the EUA.

    “It would be easy to review their data because they have already been evaluated in the US.

    Therefore, our own experts need not repeat some of the clarificatory questions,” said Domingo.

    The government is buying 148 million doses of vaccines to vaccinate about 50 million to 70 million Filipinos this year. This does not include the donated 600,000 doses from Sinovac donated by China.

    Also experiencing delays are 117,000 doses from Pfizer, under the COVAX Facility, which were supposed to be delivered in the middle to last week of this month, and 5.2 million to 9 million doses from AstraZeneca, also under COVAX, due to be delivered in the first to second quarter of the year.

    Government last week said the vaccine makers want an indemnification agreement.

    The bulk of vaccines procured by the government will start arriving in the third and fourth quarter of the year.

    PSG NOT COOPERATING?

    Domingo said President Duterte’s security, the Presidential Security Group, still has not responded to the FDA, and even the Department of Health, inquiries about the unauthorized inoculation of its members sometime in September or October.

    The incident is under investigation.

    “As of now, nobody is responding to us. Even the Secretary of Health already wrote them,” he said.

    “It is a big zero. As of now, we haven’t really received any information,” he added,

    VACCINATION ACT

    Senate majority leader Juan Miguel Zubiri said passage of the COVID-19 Vaccination Program Act of 2021 will be the only agenda in today’s Senate session so the measure can be passed on second and third reading after the bill was certified as urgent by President Duterte last week.

    In an interview with dzRH, Zubiri said he is optimistic that Senate Bill 2057 or the COVID-19 Vaccination Program Act of 2021, will be passed on third reading today.

    SB 2057 seeks to expedite the procurement by local government units of COVID-19 vaccines by exempting them from certain regulations of the Government Procurement Reform Act. It also seeks to create a vaccine indemnification fund which will compensate individuals who develop severe adverse reactions from COVID-19 vaccines, so manufacturers will be free from legal actions arising from vaccine-related injuries or even deaths.

    SB 2057 is a consolidation of other measures filed by several other senators.

    Sen. Juan Edgardo Angara said the vaccine indemnification program will have an initial fund of P500 million which will be handed to the Philippine Health Insurance Corporation which will be tapped to provide compensation to individuals. as determined by the Inter Agency Task Force on the Management of Emerging Infectious Diseases.

    Angara also said senators will have to decide today if they will include in SB 2057 the vaccine passport program proposed in separate measures by Sen. Nancy Binay and Grace Poe. – With Jocelyn Montemayor and Raymond Africa