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COVID 19 vaccine

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COVID-19 vaccine Update: Both Pfizer and Moderna to apply for Emergency Use Authorization for their COVID-19 vaccines

COVID-19 vaccines

Two companies, Pfizer and Moderna showed promising results with their COVID-19 vaccines as of November, 2020.

Pfizer COVID-19 vaccine

  • Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced on November 9th, 2020 that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.
  • This conclusion was based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
COVID vaccine
COVID vaccine

File:Covid-19 Vaccine Bottle Mockup.jpg
Covid-19 Vaccine Bottle Mockup

Pfizer COVID 19 vaccine

  • The study showed that the vaccine efficacy rate above 90%, at 7 days after the second dose.
  • The protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
  • They reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

Statement by Pfizer CEO

  • “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO.
  • “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen]].
  • He said further that "with today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.
  • Pfizer will share additional efficacy and safety data generated from thousands of participants in the coming weeks.
Pfizer logo
Pfizer logo

Results of Pfizer COVID-19 vaccine study

  • The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose.
  • The protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
  • As this is just a preliminary analysis, the final vaccine efficacy percentage may vary.
  • They not reported any serious safety concerns.
BioNTech Logo
BioNTech Logo

Statement by BioNTech

  • The other company involved in the vaccine development along with Pfizer is BioNTech.
  • “The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO.

Study details

  • The phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
Covid vaccine clinical trial
Covid vaccine clinical trial

Study composition

  • Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
  • The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.
  • The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
  • In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well.

Expected timeline

  • Based on current projections Pfizer and BioNTech are expected to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
  • Pfizer is expected to seek emergency use authorization or EUA before the end of November.
  • Once Pfizer seeks EUA, the FDA takes anywhere from a few hours to days.
  • WikiMD expects the COVID-19 vaccine to be available by December 2020, or early January 2021.

mRNA vaccines

  • The two frontrunners in the race to develop Covid vaccines are Pfizer and Moderna.
  • Both of these companies, along with most others, use a new vaccine production technology known as mRNA.
  • mRNA vaccines are unique both in terms of how quickly a vaccine can be designed and how quickly batches can be made.
  • Scientists design genetic material called mRNA to help us build immunity to certain viruses, including SARS-CoV-2, the coronavirus that causes Covid-19.

Moderna's COVID 19 vaccine

An independent data and safety monitoring board (DSMB) reviewing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 (study conducted by Moderna) reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults.

Moderna
Moderna

Interim analysis

The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers.

Safety and results

  • The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%.
  • The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group.
  • There were 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group.

Study collaborators

The mRNA-1273 vaccine candidate was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. It combines Moderna’s mRNA (messenger RNA) delivery platform with the stabilized SARS-CoV-2 spike immunogen (S-2P) developed by NIAID scientists.

WHO preventing coronavirus

Coronavirus: WHO declares COVID 19 a pandemic.

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WikiMD Resources - COVID 19 vaccine


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