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Your Position: Home > COVID-19 R&D > Positive Phase 1/2 Study Results of Pfizer COVID-19 mRNA Vaccine
Positive Phase 1/2 Study Results of Pfizer COVID-19 mRNA Vaccine
Release time: 2020-07-14 Source: ACRO Read: 8865

Latest News: FDA approves Pfizer vaccine for emergency use in US on December 11. It was such a significant milestone to get authorization of a vaccine within a year of scientists identifying the new coronavirus. ACROBiosystems proudly supplied all functional COVID-19 antigens for IgG assay in their phase 1/2 study


>>>Download Pfizer's slides on VRBPAC


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Until now, there are about 13 million people worldwide diagnosed with SARS-CoV-2 infected, and the pandemic is still developing. The vaccine against COVID-19 might be the most effective weapon to defeat this disease. According to the World Health Organization, there are 17 vaccines globally in the clinical stage.


On July 1, 2020, Pfizer and BioNTech announced the positive Phase 1/2 results of their jointly developed mRNA vaccine against COVID-19. These preliminary data provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 can produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera, and it does so at relatively low dose levels. You can find more details on the preprint website medRxiv. [1]


This mRNA vaccine, BNT162b1, encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, a key target of virus neutralizing antibodies. Their scientist added a Foldon trimerization motif to the end of the RBD sequence to ensure the trimeric structure, which will further increase the immunogenicity effect. A further modification was added to the mRNA sequence to increase the efficiency of in vivo translation (Figure 1).

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Figure 1. Molecule design of BNT162b1


This phase 1/2 clinical trial was conducted in the United States and Europe at the same time. 45 participants aged between 18 and 55 were randomized and vaccinated. 12 participants per dose level (10ug and 30ug) were vaccinated on Day 1 and 21, and 12 participants received a 100 μg dose on Day 1. 9 participants received a placebo.


Robust immunogenicity was observed after vaccination with BNT162b1. RBD-binding IgG concentrations were detected at 21 days after the first dose and substantially increased 7 days after the second dose given at Day 21. After the first dose, the RBD-binding IgG GMCs (10 µg dose recipients) were similar to those observed in a panel of 38 convalescent, human serology samples obtained at least 14 days after PCR-confirmed following SARS-CoV-2 infection/COVID-19 asymptomatic donors. Dose 2 with 10 µg or 30 µg BNT162b1, the RBD-binding IgG GMCs were about 8-fold to 50-fold that of the convalescent serum panel geometric mean concentrations (GMC).

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Figure 2. Immunogenicity of BNT162b1


Adverse effects include pain at the injection site, fatigue, headache, chills, muscle pain, joint pain, and fever. Most local reactions and systemic events peaked by the day after vaccination and resolved by Day 7.

 

This study had several limitations. While they used convalescent sera as a comparator, the kind of immunity (T cells versus B cells or both) and the level of immunity needed to protect from COVID19 are unknown. Further, this analysis of available data did not assess immune responses or safety beyond 2 weeks after the second dose of vaccine. Both are important to inform the public health use of this vaccine. Follow-up will continue for all participants and will include the collection of serious adverse events for 6 months, and COVID-19 infection, and multiple additional immunogenicity measurements through up to two years.


If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021. In that event, BioNTech and Pfizer would work jointly to distribute the potential COVID-19 vaccine worldwide.


In the RBD-binding IgG assay, the biotinylated S protein RBD from ACROBiosystems (Cat.No. SPD-C82E9)was bound to streptavidin-coated Luminex microspheres.


ACROBiosystems has developed a series of critical reagents for COVID-19 vaccine development and evaluation, including trimeric S protein which performed a high ratio of signal to noise (S/N), antibodies for reference and CE certified ELISA kits  which can make your experiment easier. These featured products are suitable for IgG/M antibody titer detection, neutralizing antibody titer detection and antigen titer detection to accelerate the vaccine development.

 

>>>Find out more reagents for vaccine development and evaluation


Assay data


※ SDS-PAGE & SEC-MALS: High purity & homogeneity

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Fig 3 The purity of Biotinylated SARS-CoV-2 S protein RBD, His,Avitag (Cat. No. SPD-C82E9) is greater than 90% verified by SDS-PAGE and SEC-MALS.

 

※ ELISA: High bioactivity


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Fig 4 Immobilized Human ACE2, Fc Tag (Cat. No. AC2-H5257) at 2 μg/mL (100 μL/well) can bind Biotinylated SARS-CoV-2 S protein RBD, His,Avitag (Cat. No. SPD-C82E9) with a linear range of 4-125 ng/mL.


>>Check more SARS-CoV-2 related products


Product list

Antibody isotype assay products

ACROBiosystems has developed a series of antibody isotype assay products, which can be used in detecting the isotypes of anti-SARS-CoV-2 antibody IgG1, IgG2, IgG3 and IgG4.

CategoryCat. No.Product Description
KitTAS-K014Anti-SARS-CoV-2 IgG1 Titer Serologic Assay Kit (S Protein RBD)
TAS-K015Anti-SARS-CoV-2 IgG2 Titer Serologic Assay Kit (S Protein RBD)
TAS-K016Anti-SARS-CoV-2 IgG3 Titer Serologic Assay Kit (S Protein RBD)
TAS-K017Anti-SARS-CoV-2 IgG4 Titer Serologic Assay Kit (S Protein RBD)
Antibody isotypeSAD-S35Anti-SARS-CoV-2 Spike RBD Neutralizing Antibody, Human IgG1(AS35)
SPD-S66Anti-SARS-CoV-2 Spike RBD Neutralizing Antibody, Human IgG2(AS35)
SPD-S67Anti-SARS-CoV-2 Spike RBD Neutralizing Antibody, Human IgG3(AS35)
SPD-S68Anti-SARS-CoV-2 Spike RBD Neutralizing Antibody, Human IgG4(AS35)
HRP- secondary antibodyIG1-S71Mouse Anti-Human IgG1 secondary antibody, Mouse IgG1, HRP
IG2-S72Mouse Anti-Human IgG2 secondary antibody, Mouse IgG1, HRP
IG3-S73Mouse Anti-Human IgG3 secondary antibody, Mouse IgG1, HRP
IG4-S74Mouse Anti-Human IgG4 secondary antibody, Mouse IgG1, HRP

Proteins

MoleculeCat. No.Product Description
ACE2 proteinAC2-H52H8Human ACE2 / ACEH Protein, His Tag (MALS verified)
AC2-H82E6Biotinylated Human ACE2 / ACEH Protein, His,Avitag™ (MALS verified)
AC2-H5257Human ACE2 / ACEH Protein, Fc Tag (MALS verified)
AC2-H82F9Biotinylated Human ACE2 / ACEH Protein, Fc,Avitag™
S trimer proteinSPN-C52H9SARS-CoV-2 S protein, His Tag, Super stable trimer (MALS & NS-EM verified)
SPN-C82E9Biotinylated SARS-CoV-2 S protein, His,Avitag™, Super stable trimer (MALS verified)
SPN-C52H3SARS-CoV-2 S protein (D614G), His Tag, Super stable trimer (MALS verified)
SPN-C82E3Biotinylated SARS-CoV-2 S protein (D614G), His,Avitag™, Super stable trimer (MALS verified)
S protein RBDSPD-C52H3SARS-CoV-2 (COVID-19) S protein RBD, His Tag (MALS verified)
SPD-C82E9Biotinylated SARS-CoV-2 (COVID-19) S protein RBD, His,Avitag™ (MALS verified)
SPD-C5259SARS-CoV-2 (COVID-19) S protein RBD, Mouse IgG2a Fc Tag(MALS verified)
SPD-C82AaBiotinylated SARS-CoV-2 (COVID-19) S protein RBD, Mouse IgG1 Fc,Avitag™(MALS verified)
S1 proteinS1N-C52H4SARS-CoV-2 (COVID-19) S1 protein, His Tag (MALS verified)
S1N-C82E8Biotinylated SARS-CoV-2 (COVID-19) S1 protein, His,Avitag™ (MALS verified)
S1N-C5256SARS-CoV-2 (COVID-19) S1 protein (D614G), His Tag
S1N-C82E3Biotinylated SARS-CoV-2 (COVID-19) S1 protein (D614G), His,Avitag™
S1 protein NTDS1D-C52H6SARS-CoV-2 (COVID-19) S1 protein NTD, His Tag
S1 protein CTDS1D-C52H3SARS-CoV-2 (COVID-19) S1 protein CTD, His Tag (MALS-verified)
S2 proteinS2N-C52H5SARS-CoV-2 (COVID-19) S2 protein, His Tag
Nucleocapsid proteinNUN-C5227SARS-CoV-2 (COVID-19) Nucleocapsid protein, His Tag
NUN-C82E8Biotinylated SARS-CoV-2 (COVID-19) Nucleocapsid protein, His,Avitag™

Kits

CategoryCat. No.Product Description
Neutralizing antibody titer assay kitTAS-K003Anti-SARS-CoV-2 neutralizing antibody titer serologic assay kit
IgG/M antibody titer assay kitTAS-K007Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (S protein trimer)
TAS-K001Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (S protein S1)
TAS-K002Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (S protein RBD)
TAS-K008Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (Nucleocapsid Protein)
TAS-K009Anti-SARS-CoV-2 Total Antibody Titer Serologic Assay kit(antigen sandwich)
TAS-K012Anti-SARS-CoV-2 Antibody IgM Serologic Assay kit (S protein S1)
TAS-K013Anti-SARS-CoV-2 Antibody IgM Serologic Assay kit (S RBD protein)
TAS-K018Mouse Anti-SARS-CoV-2 antibody IgG Serologic Assay kit
TAS-K019Monkey Anti-SARS-CoV-2 antibody IgG Serologic Assay kit
Antigen titer assay kitTAS-K010SARS-CoV-2 Nucleocapsid Protein Titer Assay Kit
TAS-K011SARS-CoV-2 Spike Protein Titer Assay Kit
Antibody isotype assay kitTAS-K014Anti-SARS-CoV-2 IgG1 Titer Serologic Assay Kit (S Protein RBD)
TAS-K015Anti-SARS-CoV-2 IgG2 Titer Serologic Assay Kit (S Protein RBD)
TAS-K016Anti-SARS-CoV-2 IgG3 Titer Serologic Assay Kit (S Protein RBD)
TAS-K017Anti-SARS-CoV-2 IgG4 Titer Serologic Assay Kit (S Protein RBD)

Antibodies

MoleculeCat. No.Product Description
S protein RBDSAD-S35Anti-SARS-CoV-2 Spike RBD Neutralizing Antibody, Human IgG1 (AS35)
SPD-M128Anti-SARS-CoV-2 RBD Potent Neutralizing Antibody, Chimeric mAb, Human IgG1 (AM128)
S1 proteinS1N-M122Anti-SARS-CoV-2 Spike RBD Antibody, Chimeric mAb, Human IgG1 (AM122)
S1N-M130Anti-SARS-CoV-2 Spike RBD Antibody, Chimeric mAb, Human IgG1 (AM130)

Mulligan et al., (2020). Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. medRxiv, doi: https://doi.org/10.1101/2020.06.30.20142570


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