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FDA panel approves Moderna vaccine

The U.S. Food and Drug Administration (FDA) will “rapidly” work towards granting emergency approval of Moderna Inc’s COVID-19 vaccine candidate, following the overwhelmingly recommendations from a committee of external advisors.

The latest development was announced by FDA Commissioner Stephen Hahn after the panel voted 20-0 with one abstention that the benefits of the vaccine outweighed its risks in people aged 18 and older. The one abstention was by Dr. Michael Kurilla National Institutes of Health, who said he “would prefer to see it more targeted towards people at high risk of serious and life threatening COVID disease.”

The same panel approved the Pfizer Inc and German partner BioNTech SE vaccine last week, which spurred the FDA to grant emergency use authorization (EUA) just one day later.

Use of the Moderna vaccine will offer a second option for the public to prevent contracting the potentially deadly virus, that has has devastating impact on the world health and economic sectors. It also has a distinct advantage of being shipped to remote or rural areas in that it does not require specialized ultra-cold freezers or vast quantities of dry ice for shipment and storage at -70 Celsius (-94 F) necessary for the Pfizer vaccine.

Both vaccines have been found to be about 95% effective at preventing illness in pivotal clinical trials with no serious safety issues.

The Moderna vaccine is based on new synthetic messenger RNA (mRNA) technology, and administered in two doses some 28 days apart. The Pfizer/BioNTech shot is also an mRNA vaccine.

The US signed a $1.5 billion pact with Moderna in August for the acquisition of 100 million doses. The first 20 million doses are expected to be delivered this month, with the remainder in the first quarter of next year. According to Health and Human Services Secretary Alex Azar, Moderna is prepared to ship 5.9 million doses to states and large cities nationwide as soon as granted final approval.

An emergency meeting of a U.S. Centers for Disease Control and Prevention advisory panel is expected to follow FDA approval of the Moderna’s vaccine with its own official recommendation. After that stage, US state and local public health authorities will begin administration of the first doses to the public. The first people slated to for inoculation are healthcare workers who treat COVID-19 patients and vulnerable residents and staff of nursing homes.

Meanwhile in Israel, a first shipment of Pfizer vaccinations for 975 people have been delivered to the Sheba Medical Center in Tel Hashomer, ahead of the hospital’s vaccination campaign. Prime Minister Benjamin Netanyahu and Health Minister Yuli Edelstein will be inoculated during a televised broadcast Saturday night, followed by about 50 hospital employees.

By the start of the week, Israel will begin vaccination of high-risk populations.

Many of the telephone networks for Israel’s health care providers collapsed today, as anxious citizens called to schedule appointments to receive both doses.

Israel is also anticipating delivery of the Moderna vaccine in accordance with an agreement secured by Prime Minister Netanyahu last June.