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===Klinična preskušanja===
Preliminarni rezultati [[klinično preskušanje|kliničnih preskušanj]] 1./2. faze so bili objavljeni oktobra 2020 in so kazali ba ugodno učinkovitost in varnost.<ref name="pmid33053279"/><ref name="mulligan">{{cite journal | vauthors = Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Şahin U, Jansen KU | display-authors = 6 | title = Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults | journal = Nature | volume = 586 | issue = 7830 | pages = 589–593 | date = October 2020 | pmid = 32785213 | doi = 10.1038/s41586-020-2639-4 | s2cid = 221126922 }}</ref> Istega meseca je [[Evropska agencija za zdravila]] (EMA) pričela s sprotnim pregledom dokumentacije cepiva BNT162b2.<ref>{{cite news |vauthors=Hannah B |date=7. 10. 2020 |title=EMA begins rolling review of BNT162b2 COVID-19 vaccine |work=European Pharmaceutical Review |url=https://www.europeanpharmaceuticalreview.com/news/129817/ema-begins-rolling-review-of-bnt162b2-covid-19-vaccine |access-date=11. 11. 2020 |archive-date=11. 11. 2020 |archive-url=https://web.archive.org/web/20201111123200/https://www.europeanpharmaceuticalreview.com/news/129817/ema-begins-rolling-review-of-bnt162b2-covid-19-vaccine/ |url-status=live }}</ref> Gre za kontinuirano klinično preskušanje, ki je prešlo v 3. fazo.<ref name="NCT04368728"/> Klinično preskušanje je [[Randomizirano nadzorovano preskušanje|randomizirano]], [[S placebom nadzorovano preskušanje|nadzorovano s placebom]] in delno slepo, s ciljem ovrednotiti ustrezen [[odmerek]], izbrati ustrezno kandidatno cepivo (izmed dveh vključenih cepiv, BNT162b1 in BNT162b2) ter ovrednotiti učinkovitost in varnost pri zdravih posameznikih.<ref name="NCT04368728"/> Tekom preskušanja so izbrali cepivo BNT162b2 za nadaljno vrednotenje pri večjem številu posameznikov in določitev. Vključenih je bilo več držav in več deset tisoč posameznikov, ki so prejeli preskušano cepivo. V kliničnem preskušanju podjetje BioNTech sodeluje s Pfizerjem in Fosunom.<ref name=herper/><ref name=fosun/>
The Phase III trial assesses the safety, efficacy, tolerability, and [[immunogenicity]] of BNT162b2 at a mid-dose level (two injections separated by 21 days) in three age groups: 12–15 years, 16–55 years or above 55 years.<ref name="NCT04368728"/> For approval in the EU, an overall vaccine efficacy of 95% was confirmed by the EMA.<ref name=":0">{{Cite web|last=|first=|date=21 December 2020|title=EMA Assessment Report|url=https://www.ema.europa.eu/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf|url-status=live|archive-url=|archive-date=|access-date=29 December 2020|website=www.ema.europa.eu}}</ref>
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