Experts on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted Thursday night to recommend the approval of Moderna’s coronavirus vaccine for emergency use, clearing the way for a second COVID-19 vaccine for U.S. adults. Final approval from both the FDA and CDC for Moderna’s mRNA-1273 could come today or over the weekend.
Twenty of the 21 experts on the VRBPAC voted to greenlight the vaccine, with one panelist abstaining. In a Phase 3 trial, mRNA-1273 showed an efficacy rate of 94.1%. There were no serious side effects from the two-dose vaccine, with minor common effects including injection site pain, erythema (reddening of the skin) and swelling.
While the VRBPAC’s vote is just a recommendation, the FDA is likely to follow its lead and approve the vaccine. As soon as that happens, nearly 6 million doses of mRNA-1273 will be shipped to 3,000 sites across the country next week.
Last week, the U.S. government exercised its option to purchase an additional 100 million doses of mRNA-1273, bringing its confirmed order commitment to 200 million doses. Of the first 100 million doses—purchased back in August—approximately 20 million doses will be delivered by the end of this month, and the balance will be delivered in the first quarter of 2021. The additional 100 million order this week is set to be delivered in the second quarter of 2021.
Moderna also announced an important update regarding vaccine handling and storage during the VRBPAC meeting Thursday. The biotechnology company said mRNA-1273 can now be transported locally under controlled conditions in a liquid state at 2 to 8˚C, which is the standard refrigerator temperature. Previously, Moderna had said the vaccine should be kept at -20°C during shipping and long-term storage, with 2 to 8˚C only suitable for 30-day, on-site storage.
“In some cases, this may be the only practical means of distribution from clinics and for remote locations. This important update will help facilitate distribution to the final site of administration. Recognizing that shipping and handling of product can be a barrier to vaccination, Moderna remains committed to supporting efficient distribution,” the company said in a press release.
The ability to transport mRNA-1273 at a standard refrigerator temperature is a huge boost for remote areas around the globe, including rural locations in the United States. It should also expand injection site options given that refrigerators are universal in most doctor’s offices and pharmacies.
This is in contrast to the only currently approved coronavirus vaccine. Pfizer and BioNTech’s BNT162b2 vaccine needs to be stored at -70°C all along the cold chain. It is one of the first vaccines to require that ultra-cold temperature, meaning current cold chain infrastructure is not sufficient to meet the demand. To compensate, Pfizer designed temperature-controlled shipping packages that use dry ice to keep vaccine vials stable for 15 days. Each suitcase-sized shipping container is equipped with a GPS-enabled thermal sensor to track both the location and temperature of the vaccine vials. In the week since BNT162b2 was approved, there have been no reports of transportation and/or distribution issues for the ultra-cold vaccine.
The U.S. government signed an agreement with Pfizer to deliver 100 million doses of BNT162 immediately after approval, with the option to acquire 500 million additional doses throughout 2021. Earlier this week, Pfizer said it was working with the U.S. to deliver 100 more doses of the vaccine in the second quarter of 2021, rather than the third. If that comes to fruition, between Pfizer and Moderna, 400 million doses of coronavirus vaccines could be delivered by the second quarter of 2021.