FDA: No one will be forced to get COVID vaccine

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    NO one will be forced to get a vaccine for the coronavirus disease (COVID-19), in the event it becomes available in the country.

    This was the assurance given yesterday by the Food and Drug Administration to the public, amid fears generated by controversies surrounding the anti-dengue vaccine Dengvaxia.

    “Vaccination cannot be done by force. You cannot force anybody to get vaccinated against COVID-19,” said FDA Director General Rolando Enrique Domingo in a virtual press briefing.

    He said a vaccine can be administered only to individuals who have been fully informed of both potential benefits and adverse effects of the product. “When we get immunized, we must have a full understanding of its benefits as well as possible risks or side effects,” he said.

    Domingo said this is the reason for the Department of Health’s plan to conduct a massive information drive regarding the forthcoming COVID-19 vaccine.

    “We are already planning to have an education campaign for people to be able to understand what the vaccination is, what it is for, what are the risk and benefits, so that people can make an informed decision,” he said.

    The assurance of the FDA comes amid calls on social media for the public no to get COVID-19 vaccines because its development and manufacture is supposedly being rushed.

    An anti-vaccine movement in the United States has spread to Canada and United Kingdom.

    In the Philippines, it was back in November 2017 when French drugmaker Sanofi Pasteur disclosed the risks brought by Dengvaxia, which was given by the DOH to almost a million school-aged children.

    This resulted in a plunge in vaccine confidence in the country to 32 percent from 93 percent, as parents became hesitant to have their children vaccinated.

    For COVID-19 vaccine, the National Task Force against COVID-19 has said government aims to vaccinate 60 million to 70 million Filipinos in three to five years.

    Vaccine czar Carlito Galvez Jr. also said that the government has already come up with a list of 35 million people, who will get the vaccine first.

    The priority list includes healthcare workers; frontliners like policemen, soldiers, and essential workers of the social welfare and education departments; poor households; and indigents.

    EMERGENCY USE

    The FDA said it will come out with implementing guidelines on the issuance of emergency use authorization (EUA) for COVID-19 treatment drugs and vaccines next week.

    Once the guidelines are out, pharmaceutical companies are that have applied or secured EUAs in other countries are expected to also submit their applications.

    “We can hope that after they get an EUA in the United States or United Kingdom, they will also apply for EUA in other countries like the Philippines,” said Domingo.

    “And once they do within the month, then it is possible that we would be able to issue the EUA within another 3 to 4 weeks, or by January,” he added.

    Domingo said among the companies expected to apply immediately are those that are already in Phase 3 of their clinical trials.

    These are the candidate vaccines of China’s Sinovac, United States’ Pfizer, United Kingdom’s AstraZeneca, and Russia’s Gamaleya.

    Earlier, President Duterte signed Executive Order No. 121, which grants the FDA the authority to issue EUAs for COVID-19 treatment drugs and vaccines that are still under development.

    Under the EO, EUAs may be issued under three conditions, namely if there is reason to believe the drug or vaccine may be effective in preventing, diagnosing, or treating COVID-19; if the potential benefits of the vaccines outweigh possible risks; and if there is no adequate, approved, and available alternative to the drug or vaccine.