COVID-19 Vaccine Developers Announce New Authorizations for Global Use

Vaccines against the coronavirus disease 2019 (COVID-19) continue to increase in use around the world. In the past week, Moderna and AstraZeneca have collectively announced multiple authorizations for use of their respective vaccines. Among the countries taking action are the United Kingdom (UK), Israel, and India, as well as with the European Commission (EC), which serves 27 member states.^1-4

Moderna’s COVID-19 vaccine (mRNA-1273) has been granted Emergency Use Authorization (EUA) in the United States for the prevention of COVID-19, which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in December 2020. Pfizer's and BioNTech’s COVID-19 vaccine (BNT162b2) also received an EUA from the FDA late last year.⁵ These vaccines are both being administered across the United States to those who are eligible to receive them, including frontline health care workers.

AstraZeneca is currently conducting a large trial of its vaccine in the United States and in other countries.⁶ It has not received an EUA from the FDA, and none of the COVID-19 vaccines have received FDA approval.^5-6

Moderna announced today it had received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for temporary authorization of mRNA-1273. This authorization permits the supply of the vaccine but does not allow marketing of the product.¹

The authorization follows similar actions on mRNA-1273 that were taken earlier this week by Israel and the European Union.^2,3

In Israel, the Ministry of Health (MOH) granted authorization to import mRNA-1273. The MOH has secured 6 million doses of Moderna’s vaccine.²

The EC granted a conditional marketing authorization based on the recommendation of the European Medicines Agency (EMA) or mRNA-1273, which allows vaccination programs across the EU to use Moderna’s product. The EMA has confirmed orders of 160 million doses of mRNA-1273 for its member states.³

Overall, mRNA-1273 now has authorizations for use from 5 governing bodies, including those in the United States and Canada, whose respective agencies took action in December 2020. According to Moderna, additional authorizations are currently under review in Singapore, Switzerland, and in other countries.³ The company previously announced an agreement with the Republic of Korea for the purchase of 40 million doses, although that country has not yet authorized use of the vaccine.⁵

In an announcement made Wednesday, AstraZeneca officials said its COVID-19 vaccine (formerly AZD1222) is now authorized for emergency use in India. According to the company, it has partnered with Serum Institute of India for supplying the vaccine to the Indian government, as well as to low- and middle-income countries.⁴

According to AstraZeneca, this vaccine is also authorized for emergency use in Argentina, Dominican Republic, El Salvador, Mexico, and Morocco,⁴ as well as the UK.⁶ Additionally, the company is seeking approval from the EMA for conditional marketing authorization in the EU.⁴

Pfizer's and BioNTech’s COVID-19 vaccine has also been granted authorizations in multiple countries, including the EU.⁵

REFERENCES

• United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna [news release]. Cambridge, MA; January 8, 2021. Accessed January 8, 2021. https://investors.modernatx.com/news-releases/news-release-details/united-kingdom-medicines-and-healthcare-products-regulatory
• Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel [news release]. Cambridge, MA; January 4, 2021: Moderna. Accessed January 8, 2021. https://investors.modernatx.com/news-releases/news-release-details/israeli-ministry-health-authorizes-covid-19-vaccine-moderna-use
• European Commission Authorizes COVID-19 Vaccine Moderna in Europe [news release]. Cambridge, MA; January 6, 2021: Moderna. Accessed January 8, 2021. https://investors.modernatx.com/news-releases/news-release-details/european-commission-authorizes-covid-19-vaccine-moderna-europe
• Serum Institute of India obtains emergency use authorization in India for AstraZeneca’s COVID-19 vaccine [news release]. January 6, 2020; Cambridge, UK; January 6, 2021. Accessed January 8, 2021. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/serum-institute-of-india-obtains-emergency-use-authorisation-in-india-for-astrazenecas-covid-19-vaccine.html
• COVID-19 Vaccine Purchases Increase Around the World. Pharmacy Times^®. Published December 31, 2020. Accessed January 8, 2021. https://www.pharmacytimes.com/news/purchases-of-covid-19-vaccines-increasing-around-the-world
• United Kingdom Authorizes Emergency Supply of AstraZeneca’s COVID-19 Vaccine. Pharmacy Times^®. Published December 30, 2020. Accessed January 8, 2021. https://www.pharmacytimes.com/news/uk-authorizes-emergency-supply-of-astrazenecas-covid-19-vaccine