Most countries on this list only issued emergency use authorizations (or equivalents), apart from the United Arab Emirates and Bahrain, which have approved Sinopharm. The information provided in this report is current as of January 29, 2021.
- On December 11, 2020, the FDA issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, Comirnaty. The authorization allows Cominarty to be distributed in the United States.
- Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research, stated, “While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States.” The FDA’s last change to the Pfizer’s EUA was on December 23, 2020 (an alteration of the number of doses per vial).
- On December 18, the FDA issued an EUA for the Moderna-NIH Vaccine, called mRNA-1273.
- According to the FDA, “EUAs are in effect until the emergency declaration ends but can be revised or revoked as we evaluate the needs during the emergency and new data on the product’s safety and effectiveness, or as products meet the criteria to become approved, cleared, or licensed by the FDA.”
- The country has not fully approved any vaccines yet. For continued marketing “after the COVID-19 public health emergency ends, manufacturers will need to receive a full approval or clearance from the FDA.”
- On December 16, 2020, Israel’s Health Minister announced that the Pfizer-BioNTech COVID-19 Vaccine was now authorized for import. Vaccinations began on December 19.
- On January 04, 2021, Israel’s Minister of Health issued an emergency authorization to import to Moderna as well.
- Both vaccines were authorized under Regulation 29 (A) of The Pharmacists Ordinance. It is a conditional/limited approval for emergency use in cases of epidemic or contagious diseases. The authorization does not have an established date to expire, but the regulation imposes a five years maximum period.
- On April 1, 2020, the MHRA announced new guidelines for COVID-19-related medicines. All the authorizations granted under the new guidelines are temporary. Additionally, some guidelines differ from the EU.
- On December 02, the UK issued an EUA for the Pfizer-BioNTech COVID-19 Vaccine, becoming the “first Western country to give such an approval to a coronavirus vaccine.”
- On December 30, the UK was also the first country to authorize the AstraZeneca-Oxford Vaccine for emergency use.
- On January 8, the country also extended an emergency use authorization to Moderna.
- On January 28, the MHRA amended the authorizations, saying they apply supply within the United Kingdom of Great Britain and Northern Ireland; the first authorization only applied to England, Scotland and Wales. The amended documents make it clear that the vaccines do not have marketing authorization.
- The UK has not issued any marketing authorization to date (29/01), meaning the vaccines are not fully approved.
- Temporary authorizations are valid until “expressly withdrawn by MHRA or upon issue of a full market authorization by the MHRA.”
United Arab Emirates
- The United Arab Emirates (UAE) approved Sinopharm emergency use on September 14, 2020, for frontline workers.
- On December 09, 2020, the UAE officially approved Sinopharm’s vaccine.
- On December 22, 2020, the Ministry of Health and Prevention announced the emergency use registration of Pfizer’s vaccine.
- On January 21, 2021, the United Arab Emirates (UAE) approved Gamaleya Research Institute’s vaccine, Sputnik V, for emergency use. It is unclear when Pfizer’s and Gamaleya’s authorizations will expire.
- On November 03, 2020, Bahrain granted emergency use authorization to the Sinopharm vaccine.
- On December 04, 2020, Bahrain granted emergency use authorization to the Pfizer-BioNTech COVID-19 Vaccine.
- On December 13, 2020, Bahrain approved the official registration (approval) for Sinopharm vaccine.
- On January 27, 2021, Bahrain’s National Health Regulatory Authority approved the emergency use of the Oxford-AstraZeneca Covid-19 vaccine. It is unclear when the authorizations will expire.
- On September 16, 2020, Canada approved the “Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19″ (Interim Order for Drugs and Vaccines), which provides regulatory support to expedite the approval of COVID-19-related drugs and vaccines.
- On December 09, 2020, Canada granted authorization for the emergency use of the Pfizer-BioNTech COVID-19 Vaccine under Health Canada’s “Interim Order.”
- On December 23, Canada also authorized Moderna’s vaccine for emergency use.
- According to reports published on January 29, 2021, Canada is expected to complete its review of AstraZeneca’s COVID-19 vaccine in the coming days.
- The Interim Order that granted emergency authorization to the vaccines expires in one year. All the authorizations granted under this order will expire with it. In December, the country announced it had started the consultation process to transition the vaccines to a “permanent market authorization under the relevant regulatory regime.”
- According to Health Canada, a “transition pathway will be put in place before the interim order has expired so that authorizations issued under it can continue. This will consist of measures to enable products authorized under the interim order to seek approvals under the Food and Drug Regulations.”
Denmark and France
- France and Denmark are part of the EU, which approved and negotiated the vaccines as a bloc. Therefore, the European Medicines Agency (EMA) is in charge of emergency authorizations and approvals. For this reason, the countries are being presented together as most of the data regarding EUA is the same.
- With the assistance of members’ medicine agencies, the EMA reviews the applications and provide its recommendation to the European Commission on whether conditional marketing authorizations can be granted so that EU countries, including Denmark and France, can start using them. Countries do get to choose if they will adopt the vaccines after the EU’s approval.
- Instead of an “emergency use authorization,” the EU issues “conditional marketing authorizations.” The principles are the same. If public health requires an urgent intervention, and it is declared that the “benefit of immediate availability of the medicine outweighs the risk,” medicines may be granted authorization for use based on less clinical data with expedited processes.
- On December 21, 2020, the EU announced that the Pfizer vaccine (Comirnaty) had received conditional marketing authorization following EMA’s assessment.
- On January 6, 2021, the EMA granted conditional marketing authorization for Moderna.
- On December 21, 2020, Denmark announced that the Pfizer vaccine would be part of the country’s vaccination plans. On January 06, the Danish Health and Medicines Authority’s director, Søren Brostrøm, announced the country would adopt the Moderna vaccine.
- On December 24, 2020, France’s Health Authority HAS announced it had approved Pfizer’s vaccine for a nationwide rollout. On January 8, 2021, HAS announced that it “had approved the coronavirus vaccine developed by Moderna for rollout in France, after the European Medicines Agency gave its go-ahead this week.”
- On January 29, 2021, the EU granted conditional marketing authorization to the AstraZeneca-Oxford vaccine. The Danish Health Authority already stated that the vaccine would be a welcome addition, especially after the country did not receive the number of doses it was expecting from Pfizer.
- France’s position is still unclear. On January 29, hours before the EU announced the approval, Macron stated that the vaccine appeared to be “quasi-ineffective” on those older than 65. He further added, “The real problem on AstraZeneca is that it doesn’t work the way we were expecting it. We’re waiting for the EMA [European Medicines Agency] results, but today everything points to thinking it is quasi-ineffective on people older than 65, some say those 60 years or older.”
- The EU has not fully approved any vaccines.