The Centers for Disease Control and Prevention says the first long-term booster shots for Coronavirus patients are ready for shipment, now that the Food and Drug Administration has certified the medication as safe and effective.
Linshuy Hsu, director of the San Francisco Division of Laboratory Medicine, and her team met with the FDA last October to seek certification as manufacturer of a Coronavirus attenuated vaccine. They’ve waited months for approval because, besides being a new vaccine, it needs to be able to circulate in the bodies of those who need it for a prolonged period. And, more importantly, a third party must also certify that the vaccine does not pose a risk to immunosuppressed individuals or to people carrying the virus. After the FDA agreed to the manufacturer’s request for certification, they set an independent review board to vet the vaccine’s medical claims for accuracy and applied for a facility in South Carolina to keep the batches refrigerated and available for further testing.
The FDA today said that the confirmed Coronavirus dose will be in six lots and there are vaccines to treat a variety of coronaviruses, including the SARS coronavirus, the MERS coronavirus, and a fifth coronavirus, the Vibrio parahaemolyticus virus that can cause the severe cases that make it to infected in a coronavirus outbreak. But if each supply runs out, the FDA will be able to oversee the availability of the remainder. The three lots approved as a final evaluation to be used by the Coronavirus task force include one that may protect against the developing FZVIII, a virus that has spread across Asia to affect about 10 cases in Korea and Australia, and the N7 serotype, the virus that has killed just one person and been linked to 61 confirmed and 16 probable cases of SARS-like illness in Taiwan since 2015. There have been two confirmed deaths and numerous reported illnesses.
Those who are still concerned that the current vaccine shortage will hurt prevention efforts against coronaviruses can access the FDA Vaccine Information Center’s CORV website, where there are information and/or links to CDC Vaccine Fact Sheet.
Read the full story at The New York Times.
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