Approved Vaccines

Vaccines | 223

Thomas Kamradt Bernd Sebastian Kamps Revised: 9 April

As of 23 May 2021, four COVID-19 vaccines have been approved or authorized for emergency use in the EU or the US (see also Table 1): • The BioNTech/Pfizer vaccine. Trade name: Comirnaty™ (tozinameran, formerly known as BNT162b2) • The Moderna vaccine, also known as mRNA-1273 • The AstraZeneca/University of Oxford vaccine. Trade name: Vaxzevria™/Covishield™ (formerly known as ChAdOx1 nCoV-19, AZD1222) • The Johnson & Johnson (Janssen) vaccine, also known as Ad26.COV2.S

Outside the EU and the US, four other vaccines have been approved: • BBIBP-CorV, Sinopharm and the Beijing Institute of Biological Products – first approved in China on 30 December 2020 • Covaxin, Bharat Biotech – first approved in India on 3 January 2021 • Sputnik-V, Gamaleya Research Institute – first approved in Russia, 28 December 2020

• Convidecia, CanSinoBIO – first approved in China, 25 February 2021

224 | CovidReference.com

Table 1. SARS-CoV-2 vaccines approved in Europe (EMA) and the US (FDA)

Vaccine™

Storage

Comirnaty™ (Tozinameran, formerly BNT162b2) 95% –25°C to 15°C for a max. of two weeks (–13°F to 5°F) 16+ years 2 x 3 weeks apart Polack 2020 Mulligan 2020 FDA EUA FDA briefing doc Sponsor briefing doc Recommendation for use

N.N.™ mRNA-1273 94% –20°C (–4°F)

Vaxzevria™ (formerly AZD1222, ChAdOx1 nCoV-19)

N.N.™ Ad26.COV2.S 62-90% 2-8°C (fridge) (36-46°F)

67% 2-8°C (fridge) (36-46°F) 18+ years 2 x 4 weeks apart Polack 2020 Jackson 2020 FDA EUA FDA briefing doc Sponsor briefing doc Recommendation for use

18+ years 55+ years 65+ years Suspended (see below*) 2 x up to 12 weeks apart Voysey 2020 Folegatti 2020 MHRA Decision EMA 20210129 EMA Overview

18 years and older 1 x FDA 20210226 EMA 20210311 Stephenson 2021

After an unusually frequent occurrence of cerebral sinus vein thromboses less than two weeks after injection of the AstraZeneca vaccine (mostly in younger women), several European countries stopped the use of the vaccine (Netherlands, Denmark, Norway) or restricted its use to people > 55 years of age (France, Canada), > 60 (Germany) or > 65 (Sweden, Finland). German authorities are now considering offering a second injection with another vaccine.

In December 2020, a Belgian minister tweeted the price that the EU had agreed to pay for COVID vaccines (The Guardian). The University of Oxford/AstraZeneca vaccine is the cheapest and Moderna is the most expensive: