COVID-19 vaccine rollout: Speed without compromising safety
According to reports, the first batch of COVID-19 vaccines to be administered to Filipinos will arrive in February, as part of a contract for 25 million doses to be delivered over the year. The government said the vaccine will only be used once it obtains an emergency use authorization (EUA) from the Philippines’ Food and Drug Administration (FDA).
Given the managerial constraints, including the low prestige and power of the Department of Health (DOH), the government is doing well getting the much-needed vaccine into the country as early as next month. The stipulation that the vaccine will be put into large-scale use only if the FDA issues an EUA is correct, and should protect the population against undue risk of side effects.
But what happens if the FDA does not grant the EUA? Hopefully, the procurement contract is conditional, meaning that
Sinovac takes back its vaccine if it is not approved, and returns payments made. If the contract is not conditional, Filipino taxpayer money will be lost. Based on cost estimates, 25 million doses would be more than P40 billion.
With such amounts at stake, there may be pressure on the FDA. Therefore, it is essential that other branches of government protect the integrity of the FDA, whatever the potential losses. As for the FDA, it should be transparent about its decision-making, preferably making the main criteria public. Good communication about the regulatory process ensures trust among the population. The communication drive should be led by the FDA and the DOH.
There is no such thing as an absolutely 100-percent safe vaccine (or drug or medical procedure). As different new vaccines are rolled out, the DOH should set up a system for monitoring side effects (phase 4 studies). If that had been done for Dengvaxia, the sad debacle around the dengue vaccine would have been avoided.
ALLAN SCHAPIRA, MD
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