CDC Advisory Committee on Immunization Practices Recommends Moderna’s Vaccine for COVID-19

The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously voted (11-0) in favor of recommending the use of mRNA-1273, Moderna’s vaccine against the coronavirus disease 2019 (COVID-19), under the Emergency Use Authorization (EUA) issued by the FDA on Friday.¹ This vaccine is indicated for use in individuals aged 18 years and older, and is the second COVID-19 vaccine to be granted EUA designation, joining BNT162b2, by Pfizer and BioNTech.^1,2

The ACIP recommendation for mRNA-1273 follows the committee's December 1, 2020 recommendation for a phase 1a rollout in which the first priority for COVID-19 vaccines is health care personnel treating patients and residents in long-term care facilities. This ACIP recommendation will be forwarded to the director of the CDC and the US Department of Health and Human Services (HHS) for review and adoption.¹

“Since we began this journey in January, our goal has always been to protect as many people as possible and this ACIP recommendation is another step forward in our quest to address this devastating pandemic with a vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna, in a prepared statement issued Saturday night. “Health care workers have been on the front lines of the fight against the virus and are an inspiration to us all. We look forward to vaccinations of this important population starting this week.”¹

Comprised of independent health experts, the ACIP advises the CDC on the populations and circumstances for which vaccines should be used.¹ The committee also recommended the Pfizer-BioNTech vaccine for COVID-19, on December 12, 2020, a day after the FDA issued its EUA for BNT162b2.³

ACIP based its recommendation for mRNA-1273 on clinical evidence supporting Moderna's vaccine, including data from the 30,000 participant phase 3 COVE study as well as ACIP’s interim guidance on the allocation of initial vaccine doses.¹

The primary efficacy analysis conducted on 196 cases in the COVE study indicated a vaccine efficacy rate of 94.1%. The most common solicited adverse reactions (ARs) after the 2-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). While the majority of these ARs were grade 1 or grade 2, there was a higher occurrence of grade 3 reactions after the second injection. The majority of local solicited ARs occurred within the first 1 to 2 days after injection and generally persisted for a median of 1 to 2 days.²

The EUA for Moderna’s COVID-19 vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use, unless terminated or revoked. According to Moderna, the company will continue to gather additional data and plans to file a Biologics License Application with the FDA requesting full licensure in 2021.¹

Under Operation Warp Speed, the US Department of Defense, in partnership with HHS and the CDC, will manage allocation and distribution of the vaccine in the United States. Approximately 20 million doses will be delivered to the US government by the end of December 2020. The Company expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the US.¹

Additionally, Moderna announced Friday that the European Commission (EC) has exercised its option to purchase an additional 80 million doses of mRNA-1273, bringing the EC’s confirmed order commitment to 160 million doses. The doses purchased by the EC will commence from a dedicated European supply chain.²

Health care facilities around the country began administering BNT162b2 this past week with pharmacists, physicians and nurses among the first to receive the COVID-19 vaccine.⁴

REFERENCES

• U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older [news release]. Cambridge, MA; December 19, 2020: Moderna. Accessed December 20, 2020. https://investors.modernatx.com/news-releases/news-release-details/us-cdc-advisory-committee-immunization-practices-recommends
• Coppock K. FDA Grants Emergency Use Authorization to Moderna COVID-19 Vaccine. Pharmacy Times^®. Published December 19, 2020. Accessed December 20, 2020. https://www.pharmacytimes.com/news/fda-grants-emergency-use-to-moderna-covid-19-vaccine
• Media Statement from CDC Director Robert R. Redfield on Signing the Advisory Committee on Immunization Practices’ recommendation to use Pfizer’s COVID-19 vaccine in people 16 and older [news release]. Atlanta, GA; December 13, 2020: CDC. Accessed December 20, 2020. https://www.cdc.gov/media/releases/2020/s1213-covid-vaccine.html
• Health Workers Lead the Charge, Receiving First COVID-19 Vaccines in Rochester, New York. Pharmacy Times^®. Published December 17, 2020. Accessed December 20, 2020. https://www.pharmacytimes.com/news/health-workers-lead-the-charge-receiving-first-covid-19-vaccines-in-rochester-new-york