BNT162b2

COVID-19 candidate vaccine

Phase of research

Approved by FDA

How it helps

Vaccine

Drug status

Experimental

48
Supporting references
0
Contradictory references
54
Clinical trials

General information

BNT162b2 is a candidate vaccine being developed by BioNTech/Pfizer. It is an mRNA type of candidate vaccine based on the RNA platform. Currently, this COVID-19 candidate vaccine is in clinical evaluation. Data from phase I/II clinical trials showed BNT162b1's immunogenicity and transient mild to moderate adverse effects only (Mulligan et al., 2020). On November 9, 2020, Pfizer and BioNTech announced that this vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis from phase 3 study. 

On December 2, 2020, the COVID-19 mRNA vaccine BNT162b2 received an emergency use authorization in the UK, and further regulatory decisions across the globe are expected. On December 9, 2020, the vaccine received conditional authorization in Canada. On December 11, 2020, the U.S. FDA issued an emergency use authorization, allowing the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S. On December 21, 2020, the BNT162b2 vaccine was granted conditional marketing authorization by the European Commission following the European Medicines Agency's recommendation, making it available for all EU member states. 

A mass vaccination program is underway, starting on December 8, 2020, in the UK, with many countries following.

On March 31, 2021, Pfizer/BioNTech announced positive topline results of pivotal COVID-19 vaccine study in adolescents. In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated.

On May 5, 2021, Canada was the first country to expand the vaccine authorization to include individuals aged 12 to 15. On May 10, 2021, the vaccine received authorization for emergency use in adolescents in the USA. On May 28, 2021, Comirnaty became the first COVID-19 vaccine approved for children aged 12 to 15 in the EU. 

On August 23, 2021 FDA granted a full approval for Comirnaty for individuals 16 years of age and older.

 


Synonyms

BNT162b; Pfizer-BioNTech COVID-19 Vaccine


Marketed as

COMIRNATY®


Supporting references

Link Tested on Impact factor Notes Publication date DB entry date
Effectiveness of COVID-19 vaccines against the B.1.617.2 variant
Preprint
adults

The Pfizer-BioNTech vaccine was 88% effective against symptomatic disease from the B.1.617.2 variant 2 weeks after the second dose, compared to 93% effectiveness against the B.1.1.7 variant.

May/22/2021 May/24/2021
Prior SARS-CoV-2 infection rescues B and T cell responses to variants after first vaccine dose
RNA Mixed substance Cohort study
Sera of vaccinated (non)convalescent subjects 41.85

A single vaccine dose in subjects with COVID-19 infection history elicited potent T cell and B cell responses against SARS-CoV-2 variants B.1.1.7. and B.1.351. The single dose regimen elicited significantly weaker responses in infection-naïve subjects. Sample size: Sera of vaccinated (non)convalescent subjects. Dosage: A single dose.


Apr/30/2021 May/09/2021
Safety and immunogenicity of one versus two doses of the COVID-19 vaccine BNT162b2 for patients with cancer: interim analysis of a prospective observational study
Spike protein RNA Cancer Mixed substance Cohort study
Vaccinated subjects with cancer 33.75

The seroconversion rate in cancer patients was lower compared to healthy controls. It was especially low after single-dose vaccination but was improved by boosting. Cancer patients were therefore suggested to be prioritized for the two-dose regimen with 21 days between the doses. Sample size: 151 + 54 healthy controls. Dosage: Single-dose or two-dose regimen. Primary outcome: Seroconversion.



Apr/27/2021 May/13/2021
Efficacy of the BNT162b2 mRNA Covid-19 Vaccine in a hemodialysis cohort
Spike protein RNA Mixed substance Cohort study
Patients on haemodialysis 4.53

Majority of haemodialysis patients who received two vaccine doses three weeks apart developed a high antibody response. The response was slightly weaker in the elderly patients. No response was observed in the patients undergoing chemotherapy and under active immunosuppression. Sample size: 326. Dosage: Standard two-dose regimen.

Apr/24/2021 May/11/2021
First dose of BNT162b2 mRNA vaccine in a Health Care Worker cohort is associated with reduced symptomatic and asymptomatic SARS-CoV-2 infection
RNA Mixed substance Cohort study
Health care workers. 8.31

A significant negative correlation was observed between the number of positive COVID-19 PCR tests and proportion of vaccinated individuals among health care workers. Dosage: A single dose.

Apr/24/2021 May/11/2021
COVID-19 vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study
Spike protein RNA Mixed substance Cohort study
Health-care workers 60.39

The effectiveness of the vaccine against both symptomatic and asymptomatic infections was calculated to be 70% 3 weeks after first dose administration and 85% 1 week after the second one. Sample size: 15,121 without previous infection (of which 1,405 not vaccinated) + 8,203 with previous infection (of which 1,278 not vaccinated). Dosage: Standard regimen.


Apr/23/2021 May/11/2021
BNT162b2 vaccination effectively prevents the rapid rise of SARS-CoV-2 variant B.1.1.7 in high-risk populations in Israel
RNA Spike variant Elderly Mixed substance Cohort study
Nursing homes residents N/A (new)

Combined with active surveillance programme, the vaccination was effective in suppressing infection spread in the cohort of nursing home residents even after B.1.1.7. strain introduction. Sample size: 292,268 RT-PCR specimens (of which 200,293 from nursing homes).

Apr/17/2021 May/11/2021
Antibody response to mRNA SARS-CoV-2 vaccine among dialysis patients - a prospective cohort study
Spike protein RNA Mixed substance Cohort study
Vaccinated haemodialysis and peritoneal dialysis subjects. 4.53

In the studied cohort, the vaccine displayed efficacy in eliciting an antibody response and was generally safe. Sample size: 122 (haemodialysis) + 23 (peritoneal dialysis). Dosage: Standard regimen.


Apr/11/2021 May/03/2021
Age‐dependent and gender‐dependent antibody responses against SARS‐CoV‐2 in health workers and octogenarians after vaccination with the BNT162b2 mRNA vaccine
Spike protein RNA Mixed substance Cohort study
Vaccinated healthcare workers and 80+ year-old volunteers. 6.97

The vaccination induced anti-RBD (SARS-CoV-2 Spike) IgG and neutralizing antibody responses in the subjects. The responses were lower in elderly, especially in male subjects, which underscores the need of administration of two doses. Sample size: 255 healthcare workers + 112 elderly volunteers. Dosage: Standard regimen. Primary outcome: Anti-RBD binding IgG and neutralizing antibody levels.

Apr/10/2021 May/02/2021
Exponential increase in neutralizing and spike specific antibodies following vaccination of COVID‐19 convalescent plasma donors
Spike protein RNA Case series Mixed substance
Vaccinated convalescent COVID-19 subjects. 2.80

Analysis pooled with

Apr/08/2021 May/03/2021
Single-dose BNT162b2 vaccine protects against asymptomatic SARS-CoV-2 infection
Spike protein RNA Mixed substance Cohort study
Vaccinated healthcare workers. 7.08

A 4-fold reduction in asymptomatic SARS-CoV-2 infection rate was observed ≥12 days after the administration of the first vaccine dose. Sample size: Ca. 9000 (with approximately equal numbers of vaccinated and non-vaccinated subjects). Dosage: A single dose.


Apr/08/2021 May/03/2021
Humoral Response to SARS-CoV-2-Vaccination with BNT162b2 (Pfizer-BioNTech) in Patients on Hemodialysis
Spike protein RNA Cohort study
Haemodialysis patients 4.42

The antibody levels in haemodialysis patients (HDPs) under 60 years of age were comparable to the control group. Lower antibody titres were observed in older HDPs, however. Sample size: 72 + 16 control (vaccinated healthcare workers). Dosage: Two standard doses, 4 weeks apart. Primary outcome: anti-SARS-CoV-2 IgGs.



Apr/08/2021 Aug/14/2021
Neutralizing Response against Variants after SARS-CoV-2 Infection and One Dose of BNT162b2
Spike protein RNA Mixed substance Cohort study
Sera of vaccinated healthcare workers 74.70

Although the neutralizing titres against the B.1.351 variant of SARS-CoV-2 were lower compared to other tested common strains, a single vaccine dose induced neutralizing antibody titres which were significantly higher than the titres measured prior to vaccination. Sample size: 6 donors. Dosage: A single dose.

Apr/07/2021 Apr/24/2021
SARS-CoV-2 mRNA vaccines induce broad CD4+ T cell responses that recognize SARS-CoV-2 variants and HCoV-NL63
RNA Mixed substance Cohort study
Peripheral blood mononuclear cells from vaccinated individuals 11.86

Vaccination elicited CD4+ T cell response which might effectively recognize some of the common SARS-CoV-2 variants.

Apr/06/2021 Apr/24/2021
Efficient maternofetal transplacental transfer of anti- SARS-CoV-2 spike antibodies after antenatal SARS-CoV-2 BNT162b2 mRNA vaccination
RNA Mixed substance Cohort study
Vaccinated pregnant women's maternal and cord blood sera 8.31

Maternal and cord blood was positive for anti-S and anti-RBD (SARS-CoV-2 Spike) IgGs, suggesting possible maternal and neonatal protection from SARS-CoV-2 infection. Sample size: 20 sera donors. Vaccine dosage: Standard regimen.


Apr/03/2021 Apr/24/2021
Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers - Eight U.S. Locations…
Spike protein RNA Mixed substance Cohort study
Frontline/healthcare workers 13.61

(Analyses pooled with

Apr/02/2021 Apr/05/2021
Antibody responses to the BNT162b2 mRNA vaccine in individuals previously infected with SARS-CoV-2
RNA In vitro Mixed substance Cohort study
in vitro binding assay; sera of vaccinated individuals 36.13

After a single dose administration, individuals with past SARS-CoV-2 infection developed anti-Spike IgG levels and capacity to inhibit ACE2-binding similar to those without previous SARS-CoV-2 infection after two doses. Sample size: 1,090 (of which 35 were infected in the past and received a single vaccine dose and 228 were not previously infected and received two vaccine doses). Dosage: One or two standard doses.


Apr/01/2021 Apr/13/2021
BNT162b2 Vaccine Encoding the SARS-CoV-2 P2 S Protects Transgenic hACE2 Mice against COVID-19
Spike protein RNA Animal model In vitro
Vero E6 cells; C57BL/6-hACE2 mice; SARS-CoV-2 isolate SARS-CoV-2/human/CHN/WH-09/2020 4.42

No viral RNA was detectable in the murine lung tissue after SARS-CoV-2 viral challenge. The immunization also alleviated pathological histological changes.

Apr/01/2021 Aug/16/2021
Anti-SARS-CoV-2 RBD IgG responses in convalescent versus naïve BNT162b2 vaccine recipients
Spike protein RNA Mixed substance Cohort study
Sera of vaccinated individuals 3.14

Anti-S1/S2 (SARS-CoV-2 Spike) IgG levels in COVID-19 convalescent individuals 14 days post immunization were similar to the levels detected in infection-naïve subjects 14 days post second vaccine dose administration. Sample size: 12 convalescent donors + 54 infection-naïve donors. Dosage: Standard regimen.


Mar/30/2021 Apr/24/2021
Initial report of decreased SARS-CoV-2 viral load after inoculation with the BNT162b2 vaccine
Spike protein RNA Mixed substance Cohort study
Vaccinated subjects (16+ years of age) 36.13

A significant reduction in the mean viral loads was noted in vaccinated individuals who got infected with SARS-CoV-2. The reduction was observed starting on day 12 post 1st dose administration. These results suggest reduced infectivity even in the vaccinated individuals positive for SARS-CoV-2.
Sample size: 4,938. Dosage: Two standard doses (analyses beginning with the 1st dose administration). Primary outcome: Average RT-PCR Ct values.


Mar/29/2021 Apr/08/2021
Anti-SARS-CoV-2 antibodies induced in breast milk after Pfizer-BioNTech/BNT162b2 vaccination
RNA Case series Mixed substance
Breast milk of vaccinated individuals 6.50

Two weeks after the first vaccine dose administration, increased anti-Spike (SARS-CoV-2) IgA titres were observed in breast milk. Although decline was noted 40+ days after the first dose (therefore, after the second dose administration), the titres were still high above baseline. Similarly, IgG anti-Spike titres were elevated in breast milk, but antibody titres for this class did not decline within the observation period. Sample size: 5 donors. Dosage: Standard vaccination regimen.


Mar/26/2021 Apr/13/2021
Single dose of a mRNA SARS-CoV-2 vaccine is associated with lower nasopharyngeal viral load among nursing home residents with asymptomatic COVID-19
Spike protein RNA Asymptomatic Mixed substance Cohort study
Asymptomatic COVID-19 patients. 8.31

The mean viral load as measured by RT-PCR on a nasopharyngeal swab sample in asymptomatic COVID-19 patients vaccinated with a single dose 12–15 days prior to the virus detection was 2.4-fold lower compared to asymptomatic non-vaccinated patients. The vaccination was therefore hypothesized to lower transmissibility of the virus even in positive (asymptomatic) individuals. Sample size: 5 + 5 control (SARS-CoV-2 positive). Dosage: All cases detected after a single immunization. Primary outcome: Nasopharyngeal viral load.



Mar/26/2021 Mar/31/2021
The effect of SARS-CoV-2 D614G mutation on BNT162b2 vaccine-elicited neutralization
RNA Animal model In vitro Mixed substance
Sera from immunized mice, rhesus macaques, and humans; SARS-CoV-2 D614 or G614 5.70

A difference in neutralizing capacity of antibodies from sera of vaccinated mice, non-human primates, and human subjects against SARS-CoV-2 D614 and G614 was detectable, but the difference was only modest.

Mar/25/2021 Mar/31/2021
mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection
Spike protein RNA In vitro Mixed substance Cohort study
Sera of (non)vaccinated convalescent and vaccinated naïve donors; SARS-CoV-2 Spike Wuhan-Hu-1 and B.1.31 pseudoviruses 41.85

(Data pooled with those for

Mar/25/2021 Mar/31/2021
Immunogenicity of the BNT162b2 vaccine in frail or disabled Nursing Home residents: COVID‐A Study
Cohort study Elderly In vitro Mixed substance RNA Spike protein
Elderly 4.18

The vaccine was safe and elicited an immune response in elderly nursing home residents. The antibody titres were higher in those with previous COVID-19 infection. The vaccine is suggested for use irrespective of frailty and disability profiles. Sample size: 134. Dosage: 2 regular doses.

Mar/25/2021 Mar/31/2021
COVID-19 vaccine response in pregnant and lactating women: a cohort study
RNA Cohort study
pregnant and lactating women 6.50 2019

COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and lactating women, with immunogenicity and reactogenicity similar to that observed in non-pregnant women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

Mar/25/2021 Apr/01/2021
Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort
Spike protein RNA Non-randomized controlled open trial Mixed substance
Patients with chronic inflammatory conditions and immunosuppressive therapy 16.10

A pooled analysis with

Mar/24/2021 Mar/30/2021
Antibody response to a single dose of SARS-CoV-2 mRNA vaccine in patients with rheumatic and musculoskeletal diseases
Spike protein RNA Mixed substance Cohort study
SARS-CoV-2-naïve patients with rheumatic and musculoskeletal diseases 16.10

(Analyses pooled with

Mar/23/2021 Apr/03/2021
BNT162b2 mRNA Covid-19 Vaccine Effectiveness among Health Care Workers
Spike protein RNA Mixed substance Cohort study
Healthcare workers 74.70

During the vaccination campaign, a marked decrease of COVID-19 incidence among healthcare workers was observed, which contrasts with epidemiologic data in general population. The decrease seems to be temporally correlated with the progress of the vaccination campaign among the healthcare workers. Sample size: 6680. Dosage: Standard two-dose regimen.


Mar/23/2021 Apr/03/2021
Antibody Responses after a Single Dose of SARS-CoV-2 mRNA Vaccine
Spike protein RNA Nucleocapsid protein Mixed substance Cohort study
Sera of single-dose vaccinated health care workers with/without COVID-19 infection history. 74.70

3 weeks after a single dose administration, the subjects without history of SARS-CoV-2 infection displayed significant increase in anti-S1, anti-S2, and anti-RBD (of Spike protein) antibody titres, yet the titres were lower compered to the subject with recently (30–60 days before vaccination) laboratory-confirmed infection or those with prior antibody levels indicating positive infection history. The anti-nucleocapsid antibody levels were not changed by the vaccination, which is in line with the vaccine design (encoded modified Spike protein serving as the immunogen). Sample size: 152 without past confirmed SARS-CoV-2 infection (6 of which with possible undiagnosed infection) + 36 with confirmed past SARS-CoV-2 infection. Dosage: A single dose. Primary outcome: Antibody responses.



Mar/23/2021 Apr/03/2021
Early Evidence of the Effect of SARS-CoV-2 Vaccine at One Medical Center
Spike protein RNA Mixed substance Cohort study
Frontline healthcare workers 74.70

(Data pooled with

Mar/23/2021 Apr/03/2021
SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies
Antibody In vitro Mixed substance Peptide RNA Small molecule Spike protein
Caco-2 cells; Vero cells; Sera of vaccinated individuals; (VSV) SARS-CoV-2 Spike-pseudotyped virus (WT, B.1.1.7, B.1.351, ant P.1 variants) 38.64

The sera of most of the vaccinated individuals manifested decreased neutralizing activity against SARS-CoV-2 Spike B.1.351 and P.1 variants. This indicates that the vaccine might provide less robust protection from the infection by viruses of the corresponding strains. The neutralizing capacity at lower tested serum dilutions was present and provided complete neutralization, however. The neutralization of B.1.1.7 was reduced only slightly.

Mar/20/2021 Apr/05/2021
Multiple SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity
RNA In vitro Mixed substance
in vitro binding assay; sera of vaccinated individuals; 293T-ACE2 cells; SARS-CoV-2 Spike pseudovirus (various variants) 38.64

SARS-CoV-2 Spike protein of some strains, especially of B.1.351 (“South Africa”), seems to be several-fold more resistant to neutralization by antibodies from vaccinated subjects compared to the wild type virus. This is especially true for individuals with a single dose vaccination without prior SARS-CoV-2 infection or exposure. The sera of subjects vaccinated with two doses, or of those with previous virus exposure, seem to retain neutralizing capacity to some extent, however.

Mar/12/2021 Mar/26/2021
Sensitivity of SARS-CoV-2 B.1.1.7 to mRNA vaccine-elicited antibodies
Biophysical assay Cohort study In vitro Mixed substance RNA Spike protein
In vitro binding assay; in vitro biophysical assay; sera of vaccinated older adults; HEK293T/17 cells; (HIV-1) SARS-CoV-2 Spike (WT or variant) pseudovirus 42.78

Sera of vaccinated older adults included antibodies which retained their neutralizing capacity against SARS-CoV-2 Spike protein variant B.1.1.7 and K417N, E484K, and N501Y triple mutant. However, some decrease in neutralization capacity of the sera against the B.1.1.7 variant was observed. Alarmingly, the neutralizing capacity against the triple mutant was decreased or completely diminished in several antibodies.

Mar/11/2021 Mar/22/2021
Impressive boosting of anti-S1/S2 IgG production in COVID-19-experienced patients after the first shot of the BNT162b2 mRNA COVID-19 Vaccine
Spike protein RNA Mixed substance Cohort study
Adults vaccinated with a single vaccine dose 8.31

While the neutralizing antibody titres after a single vaccine dose in adults with no COVID-19 infection history did not significantly increase after a single dose administration, the increase in titres of previously infected individuals was statistically and numerically significant. Sample size: 52 (COVID-19-naïve) + 69 (with COVID-19 history). Dosage: A singe dose.


Mar/06/2021 Mar/22/2021
Antibody Response to the BNT162b2 mRNA COVID-19 Vaccine in Subjects with Prior SARS-CoV-2 Infection
Spike protein RNA Case series Mixed substance
Vaccinated health-care workers 3.82

In individuals who have been infected with SARS-CoV-2 in the past a single dose of the vaccine elicited after 7 days anti-RBD IgG and neutralizing antibody responses similar to the responses in infection-naïve individuals 7 days after the second dose administration. Sample size: 5 with COVID-19 infection history + 9 infection-naïve.

Mar/05/2021 Apr/16/2021
Binding and Neutralization Antibody Titers After a Single Vaccine Dose in Health Care Workers Previously Infected With SARS-CoV-2
RNA Mixed substance Cohort study
Sera of health-care workers vaccinated with a single dose 45.54

At days 7 or 14 after a single-dose vaccination, the health-care workers with prior SARS-CoV-2 infection developed higher anti-Spike antibodies and more potent live virus neutralizing capacity compared to the non-infected subjects. Sample size: 13 with evidence of previous symptomatic SARS-CoV-2 infection + 6 with evidence of previous asymptomatic SARS-CoV-2 infection + 10 seronegative. Data were pooled with

Mar/01/2021 Mar/16/2021
Antibody response to first BNT162b2 dose in previously SARS-CoV-2-infected individuals
RNA Mixed substance Cohort study
Sera of health-care workers vaccinated with a single dose 60.39

Individuals vaccinated with a single dose had similar levels of anti-Spike (SARS-CoV-2) antibodies to the ones with previous SARS-CoV-2 infection (mild or asymptomatic). Subjects who recovered from SARS-CoV-2 infection and received a single dose of the vaccine had significantly higher anti-Spike titres. Sample size: 24 with evidence of previous SARS-CoV-2 infection + 27 seronegative. Dosage: A single dose. Primary outcome: Immunological response 19–29 (median 22) days post single-dose vaccination.



Feb/25/2021 Mar/16/2021
Effect of previous SARS-CoV-2 infection on humoral and T-cell responses to single-dose BNT162b2 vaccine
RNA Mixed substance Cohort study
Sera of health-care workers vaccinated with a single dose 60.39

Based on T cell responses, anti-Spike protein antibody titres, and neutralizing antibody titres, it was concluded that individuals who recovered from SARS-CoV-2 infection before administration of the vaccine produced significant immunological response after a single-dose administration. On the other hand, a single vaccination might be insufficient for protection against COVID-19 in some individuals, especially over 50 years of age, who were not infected prior to the vaccination. Sample size: 21 with evidence of previous SARS-CoV-2 infection + 51 infection-naïve. Dosage: A single dose. Primary outcome: Immunological response 21-25 days post single-dose vaccination.


Feb/25/2021 Mar/16/2021
BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
Spike protein RNA Mixed substance Cohort study
Vacciniated individuals of at least 16 years of age. 74.70

The effectivity of the vaccine 14 to 20 days after the first dose administration in preventing documented infection, symptomatic COVID-19, hospitalization, and severe disease was observed to be ca. 46%, 57%, 74%, and 62% respectively. The values at 7 or more days after the second dose were 92%, 94%, 87%, and 92%, respectively. The effectiveness in preventing COVID-19-caused death was estimated to be 72% for days 14 to 20 after the first immunization and 84% at the period starting 7 days after the second dose. Sample size: 596,618 matched pairs.

Feb/24/2021 Mar/04/2021
Reduced neutralization of SARS-CoV-2 B.1.1.7 variant by convalescent and vaccine sera
Cohort study In vitro Mixed substance RNA Spike protein Viral vector
Sera of vaccinated subjects; SARS-CoV-2 strain SARS-CoV-2/human/AUS/VIC01/2020 (“Victoria”); SARS-CoV-2 B.1.1.7 38.64

Although a 3.3-fold decrease in neutralization titres against B.1.1.7 strain was observed compared to an early Wuhan-related strain, the neutralization remained robust, and no evidence of vaccine escape was observed.

Feb/18/2021 Apr/03/2021
Early rate reductions of SARS-CoV-2 infection and COVID-19 in BNT162b2 vaccine recipients
RNA Mixed substance Cohort study
Vaccinated health-care workers. 60.39

The infection rate reduction in vaccinated healthcare workers was 30% 1-14 days after the first dose and 75% 15-28 days after the first dose (with 91% of the subjects receiving the second dose on day 21 or 22). Symptomatic infection rate reduction values were 47% and 85% at these time intervals, respectively. Sample size: 7,214 received the first dose of which 6,037 received the second one + 1,895 non-vaccinated.

Feb/18/2021 Mar/07/2021
mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants
RNA Cryo-EM In vitro Mixed substance
sera of immunized volunteers (the source of antibody-producing B cells); in vitro binding assay; cryo-EM; hACE2-293T cells; HT1080ACE2.cl14 cells; SARS-CoV-2 variant Spike-pseudotyped viruses 42.78

Some of the antibodies identified in the B cells from immunized volunteers which bound SARS-CoV-2 Spike S or BRD domain of the original SARS-CoV-2 were found to have a decreased or no neutralizing activity against some of the emerging Spike variants (E484K or N501Y or the K417N:E484K:N501Y combination). Overall, the plasma neutralizing activity against these variants was present but decreased.

Feb/10/2021 Mar/01/2021
Neutralization of SARS-CoV-2 spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine-elicited sera
RNA In vitro Mixed substance
Vero E6 cells; vaccinated human sera; SARS-CoV-2 strain USA-WA1/2020 - WT or with modified Spike (N501Y or Δ69/70 + N501Y + D614G or E484K + N501Y + D614G) 36.13

The differences between neutralization titres in sera from vaccinated humans (2 or 4 weeks after the 2nd dose) against modified live SARS-CoV-2 viruses carrying common Spike mutations and titres against the non-mutated form were of a moderate magnitude only (0.81- to 1.41-fold). The lowest value was observed for the E484K + N501Y + D614G combination, which corresponds to the mutations in the so-called

Feb/08/2021 Feb/15/2021
Immunogenic BNT162b vaccines protect rhesus macaques from SARS-CoV-2
Spike protein RNA Animal model Mixed substance
BALB/c mice; rhesus macaques; SARS-CoV-2 strain USA-WA1/2020 42.78

A single intramuscular dose elicited a strong immune response in mice characterized by a potent TH1 response, prevalent IFNγ-producing CD8+ T-cell response, and higher presence of germinal centre B cells in injection site draining lymph nodes and spleen. Vaccination of rhesus macaques using a prime/boost scheme resulted in SARS-CoV-2 neutralising geometric mean titres 8.2 to 18.2 more potent than those of convalescent COVID-19 patients’ sera. The macaques were protected from viral RNA presence in the lower respiratory tract. No vaccine-induced disease enhancement was observed.

Feb/01/2021 Feb/03/2021
BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans
RNA Non-randomized non-controlled open trial Preprint Phase II clinical trial Phase I clinical trial
Healthy adults

vaccination with BNT162b2 at well tolerated doses elicits a combined adaptive humoral and cellular immune response, which together may contribute to protection against COVID-19

Dec/11/2020 Jan/04/2021
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
RNA Phase III clinical trial Phase II clinical trial Randomized controlled double-blind trial Mixed substance
16+ years old volunteers 74.70

The vaccine displayed 95% efficacy in preventing COVID-19 infection with similar outcomes in all analysed subgroups. The incidence of severe adverse reactions was low and comparable with the placebo group. Sample size: 21,720 +21,728 placebo. Dosage: Two doses of 30 μg 21 days apart.


Dec/10/2020 Dec/16/2020
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020 in vitro Mar/26/2020 Apr/03/2020

Clinical trials

ID Title Status Phase Start date Completion date
NCT05077254 COVID Protection After Transplant-Immunosuppression Reduction Not yet recruiting Phase 2 Oct/15/2021 Mar/01/2023
NCT04895982 Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years Not yet recruiting Phase 2 Oct/08/2021 Feb/11/2023
NCT05057169 Randomized Trial of COVID-19 Booster Vaccinations (Cobovax Study) Not yet recruiting Phase 4 Oct/05/2021 Mar/31/2024
NCT04961229 Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response Not yet recruiting Phase 4 Oct/01/2021 Jul/01/2022
NCT05052307 A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil Not yet recruiting Oct/01/2021 Oct/01/2023
NCT05022329 COVID-19 Vaccine Boosters in Patients With CKD Recruiting Phase 2|Phase 3 Sep/30/2021 Sep/30/2023
NCT05057182 Third Dose of mRNA Vaccination to Boost COVID-19 Immunity Recruiting Phase 4 Sep/27/2021 Dec/31/2023
NCT05047640 COVID-19 3rd Dose Vaccine in Transplant Patients Not yet recruiting Phase 3 Sep/09/2021 May/30/2022
NCT04977479 The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose Recruiting Phase 2 Sep/08/2021 Dec/30/2022
NCT05049226 Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine Not yet recruiting Phase 2 Sep/01/2021 Sep/01/2023
NCT05029245 IntraDermal Versus Intramuscular Comirnaty® Efficacy Study Not yet recruiting Phase 3 Aug/31/2021 Oct/31/2022
NCT05004181 Safety and Immunogenicity of a SARS CoV 2 Multivalent RNA Vaccine in Healthy Participants Recruiting Phase 2 Aug/25/2021 Dec/01/2022
NCT05020145 COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States Active, not recruiting Aug/25/2021 Dec/31/2021
NCT04969250 Vaccination for Recovered Inpatients With COVID-19 (VATICO) Recruiting Phase 4 Aug/25/2021 Jul/01/2022
NCT05000216 COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders Recruiting Phase 2 Aug/13/2021 Dec/01/2022
NCT05016622 Booster Dose Trial Recruiting Phase 2 Aug/10/2021 Sep/01/2024
NCT04969601 Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Not yet recruiting Phase 1|Phase 2 Aug/01/2021 Feb/01/2023
NCT04949490 A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects Recruiting Phase 2 Jul/26/2021 Jul/01/2023
NCT04993560 Safety and Efficacy of COVID-19 Prime-boost Vaccine in Bahrain Completed Jul/18/2021 Oct/19/2021
NCT04955626 Study to Evaluate the Safety and Efficacy of a Booster Dose of BNT162b2 Against COVID-19 in Participants ≥16 Years of Age. Recruiting Phase 3 Jul/01/2021 Sep/29/2022
NCT04889209 Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines Recruiting Phase 1|Phase 2 May/28/2021 Dec/01/2022
NCT04880447 Special Investigation of COMIRNATY in the Population With Underlying Diseases Active, not recruiting May/26/2021 May/06/2022
NCT04775069 Antibody Response to COVID-19 Vaccines in Liver Disease Patients Recruiting Phase 4 May/21/2021 Mar/31/2022
NCT04894435 Mix and Match of the Second COVID-19 Vaccine Dose for Safety and Immunogenicity Recruiting Phase 2 May/20/2021 Mar/01/2023
NCT04887948 Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2 Active, not recruiting Phase 3 May/20/2021 Nov/29/2021
NCT04848584 Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study - Kaiser Permanente Southern California Active, not recruiting May/15/2021 Jul/30/2023
NCT04852861 COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine Enrolling by invitation Phase 4 May/10/2021 Sep/30/2022
NCT04881396 Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine Not yet recruiting May/10/2021 Jun/01/2022
NCT04907331 Heterologous SARS-CoV-2 Vaccination With ChAdOx-1 and BNT162b2 Recruiting Phase 2 May/10/2021 Dec/30/2021
NCT04848441 Risk of COVID-19 Infection After Vaccination Not yet recruiting May/01/2021 Aug/01/2021
NCT04815031 Drug Use Investigation of COMIRNATY Intramuscular Injection Recruiting Apr/20/2021 Dec/03/2022
NCT04805125 Immunocompromised Swiss Cohorts Based Trial Platform Active, not recruiting Phase 3 Apr/19/2021 Jul/01/2022
NCT04761822 COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations Recruiting Phase 2 Apr/07/2021 Nov/01/2021
NCT04834869 COVID-19 Vaccines Safety Tracking (CoVaST) Recruiting Apr/01/2021 Jan/31/2022
NCT04816669 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults Active, not recruiting Phase 3 Apr/01/2021 Oct/30/2021
NCT04952766 Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults Recruiting Phase 4 Mar/29/2021 Mar/01/2022
NCT04816643 A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults Recruiting Phase 2|Phase 3 Mar/24/2021 Jun/18/2024
NCT04951323 Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo) Recruiting Phase 3 Mar/22/2021 Jan/01/2023
NCT04932863 BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment Recruiting Mar/15/2021 Mar/15/2023
NCT04961502 Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions Recruiting Not Applicable Mar/11/2021 Sep/01/2021
NCT04898946 Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong Recruiting Mar/08/2021 Mar/08/2022
NCT04824638 BNT162b2 Vaccination With Two Doses in COVID-19 Negative Adult Volunteers and With a Single Dose in COVID-19 Positive Adult Volunteers Active, not recruiting Phase 2 Mar/08/2021 Oct/30/2023
NCT04754594 Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older Recruiting Phase 3 Feb/16/2021 Oct/15/2022
NCT04713553 A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants Completed Phase 3 Feb/15/2021 Jul/22/2021
NCT04756817 Immunogenicity of the BNT162b2 Covid-19 Vaccine in Elderly People Aged 85 and Older in Greece Recruiting Feb/13/2021 Sep/30/2021
NCT04862806 Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL Recruiting Not Applicable Feb/01/2021 Mar/01/2022
NCT04733807 Antibodies Response to mRNA Vaccine Against Covid-19 Recruiting Jan/28/2021 Feb/01/2022
NCT04743388 Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System Recruiting Jan/04/2021 Apr/01/2022
NCT04649021 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population Active, not recruiting Phase 2 Dec/04/2020 Dec/01/2021
NCT04588480 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults Active, not recruiting Phase 1|Phase 2 Oct/21/2020 Nov/24/2021
NCT04537949 A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Active, not recruiting Phase 1|Phase 2 Sep/09/2020 Feb/01/2022
NCT04523571 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects Active, not recruiting Phase 1 Jul/28/2020 Aug/01/2021
NCT04368728 Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals Recruiting Phase 3 Apr/29/2020 May/02/2023
NCT04380701 A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults Recruiting Phase 1|Phase 2 Apr/23/2020 Apr/01/2023