On Thursday, a panel of external advisers to the US Food and Drug Administration approved the urgent use of Moderna Inc’s coronavirus vaccine, which almost guaranteed a second option to protect against COVID-19 for a pandemic-ravaged nation.
The committee voted 20-0 by a landslide vote that the benefits of the vaccine outweigh the risks in people aged 18 and older, one week after the same panel supported a similar vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA Emergency Approval (EUA) one day later.
The FDA is expected to grant the EUA as early as late Thursday or Friday, giving another ray of hope to a nation that has lost more than 300,000 lives to COVID-19 – including a one-day high of 3,580 deaths on Wednesday – while setting a record the number of patients threatens to overwhelm US hospitals and healthcare professionals.
The modern vaccine will begin distributing as soon as the FDA gives the green light. Health and Humanitarian Secretary Alex Azar told CNBC on Thursday that 5.9 million doses had been allocated to state governors and were ready to be sent across the country.
However, vaccines are not a panacea, as it will take months to roll out to a nation where the virus is spreading and public health measures such as social distancing and masking are being rejected by large sections of the population.
Unlike Pfizer’s vaccine, which comes with complex distribution challenges due to its need to be transported and stored at -70 Celsius (-94 F), Moderna’s vaccine does not require specialized ultra-cold freezers or large quantities of dry ice, making it easier to supply rural areas and remote areas.
US officials have said they expect to have 40 million doses of Pfizer / BioNTech and Moderna vaccines by the end of the year – enough to inoculate 20 million people. Both vaccines were approximately 95% effective in preventing disease in important clinical trials without any serious safety concerns.
The first wave of doses is expected to be earmarked for healthcare professionals treating COVID-19 patients and vulnerable residents and nursing home staff.
Documents prepared by FDA researchers and released before the meeting say that a two-dose regimen of the Moderna vaccine was very effective in preventing COVID-19 and did not address any specific safety issues.
Perhaps even more significantly, as hospital-intensive units are being filled to capacity across the country, there were no cases of severe COVID-19 among those who received the vaccine in the study versus 30 such cases in the placebo group.
The vaccine, based on the new technology for synthetic messenger RNA (mRNA), is administered in two shots at approximately 28-day intervals. The Pfizer / BioNTech shot is also an mRNA vaccine.