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FDA Report: Pfizer’s COVID-19 Vaccine Safe, Effective. State’s First Batch Expected Within Days.

December 08, 2020

Fear is especially pervasive as the COVID-19 pandemic envelops the world in wave two, but fear of the vaccine offering protection against the virus should not prevent anyone from getting it, according to the nation’s top healthcare officials.

The Food & Drug Administration (FDA) reported that data from Pfizer’s vaccine trials raised no safety concerns despite the accelerated development and testing cycle. The FDA recently granted emergency use authorization (EUA) for the vaccine. Pfizer’s vaccine, which will begin distribution across the country within the week, is reportedly 82 percent effective after the first of two doses given 21 days apart — and 95 percent effective a week after the second dose.

Hartford HealthCare is expecting its first shipment of the vaccine as early as this weekend, which will be given first to frontline healthcare workers. This initial shipment of less than 2,000 doses is not enough to vaccinate all healthcare providers at Hartford HealthCare. More shipments are expected in the coming weeks.

“FDA has determined that the sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” reads a statement on the agency’s website.

EUA allows the vaccine to be distributed while the FDA continues to evaluate data. Full approval would take months, while the nation’s hospitals rapidly fill with patients infected with COVID-19 in what is being anticipated as the worst public health crisis ever.

The vaccine, according to the FDA, is safe and recommended for most people over the age of 16, including those who have already had COVID-19. There is currently insufficient data that would enable the agency to make recommendations for pregnant women, people with compromised immune systems and children under 16.

Dr. Sope Olugbile, a physician-scientist and hematology/oncology specialist at Hartford HealthCare with extensive experience in immunology research and vaccine development, said changes to the timeline for vaccine development do not compromise safety.

“Expediting vaccine development can only lead to wastage of resources which, in the case of a pandemic, may be a reasonable price to pay,” he said. “This is largely because the safety measures in place for vaccines are much stricter than for medicines used to treat diseases as the vaccine target population is healthy people who should not be put at risk of significant side effects.”

New drugs, he said, are typically manufactured only after companies examine data from prior development phases to keep costs down. This extends the time it takes to make a drug commercially available.

Because of the deadly nature of the COVID-19 pandemic, companies like Pfizer and Moderna have worked with the FDA to produce vaccine materials for trials before reviewing data from prior trials, Dr. Olugbile said.

At each phase of vaccine development, safety measures ensure the medication does not harm recipients, including:

• Phases I and II, researchers examine side effects experienced by study participants, determine optimum dose and frequency, and check if the vaccine elicits the desired immune response.
• Phase III involves more volunteers helping researchers assess medication efficacy and collect safety data.

“The FDA ensures that safety and efficacy are proven beyond reasonable doubts before any approval,” he said.