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Vaccine Development

Last updated: November 24, 2020  

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The following is a curated review of key information and literature about this topic. It is not comprehensive of all data related to this subject. 

Overview

The vaccine landscape for COVID-19 is rapidly evolving. Below is an overview of publicly available information regarding current vaccine trials.

Vaccine Studies

Given the large number of vaccine candidate and studies, we have summarized here all currently viable candidates in phase 1 or higher clinical trials. We have also noted relevant literature regarding the use of the vaccine candidates in human subjects.

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Phase 3 Clinical Trial Results

Below is a summary of publicly available information on phase 3 vaccine clinical trials. Some of this information is limited to press releases. We will share such information when higher level data is not available, and update once literature has been published.  

AZD1222 

In November 2020, AstraZeneca released a press statement outlining the results of a pooled interim analysis of two ongoing trials, the COV002 Phase II/III trial in the UK and the COV003 Phase III trial in Brazil. 

  • AZD1222 uses a replication-deficient chimpanzee-derived adenovirus vector which contains genetic material encoding for the SARS-CoV-2 virus spike protein. 
  • The trial is sponsored by AstraZeneca and Oxford University, and is part of Operation Warp Speed. Funding is also provided by the UK Ministry of Heatlh, Oxford University, and BARDA.  
  • Participants in both trials were randomized to receive either AZD1222, the meningococcal conjugate vaccine MenACWY, or saline. 
  • In the UK trial, 2,741 patients out of a planned 12,390 have been enrolled. 
    • Participants randomized to the vaccine received half the dose of the vaccine, followed by the full dose 1 month later. 
    • The press release reports a 90% efficacy but does not detail the numbers of participants in the placebo and intervention groups who contracted SARS-CoV-2. 
  • In the Brazil trial, 8,895 patients out of 10,300 have been enrolled. They have received 2 full doses, one month apart. 
    • The press release reports a 62% efficacy but does not detail the numbers of participants in the placebo and intervention groups that contracted SARS-CoV-2. 
  • In pooled analysis of both of the trials (11,636 patients)there were 131 cases of COVID-19. 
    • The press release reports the average efficacy is 70%.  
  • The analysis met its primary endpoint showing protection from COVID-19 occurring  >14 days after receiving 2 doses of the vaccine. 
  • There were no hospitalizations or severe cases of the disease in participants receiving the vaccine. 

Complete details of the trial and results are necessary to interpret reported findings. Further information is forthcoming.   

mRNA-1273 
In November 2020, Moderna released a press statement outlining the results of an interim analysis of their COVE study 

  • mRNA-1273 is an mRNA vaccine that is given in 2 doses, 28 days apart. 
  • The trial is sponsored by the U.S. National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority and is part of Operation Warp Speed. 
  • To date, more than 30,000 participants have been enrolled. 
  • 25,645 had received their second vaccination. 
  • notable aspect of the trial is the intentional enrollment of people typically underrepresented in clinical trials, including those over the age of 65 (7,000 participants), people with chronic illnesses (5,000 participants), and communities of color (11,000 participants; 37% of the study population).  
  • The first interim analysis was based on 95 cases of COVID-19, 90 of which were observed in the placebo group and 5 of which were observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001). 
  • There have been no significant safety concerns reported to date.  
  • Moderna has announced that based on these results it intends to seek an EUA from the FDA; the trial will continue.   
  • mRNA-1273 must be shipped and stored at 35.6-46.4 degrees Fahrenheit (2-8°C), which may affect distribution.  

Complete details of the trial and results are necessary to interpret reported findings. Further information is forthcoming.  

BNT162b2 
In November 2020, Pfizer issued a press release outlining the results of an interim analysis of their BNT162b2 phase 3 clinical trial.

  • BNT162b2 is an mRNA vaccine that is given in 2 doses21 days apart. 
  • The trial is sponsored by Pfizer and BioNTech. 
  • To date 43,538 participants have been enrolled in the trial, and 38,955 have received a second dose of the vaccine.  
  • The trial is set to continue until 164 confirmed cases of COVID-19 occur in the study population.  
  • In ainterim analysis undertaken after 94 healthy volunteers developed COVID-19: 
  • The candidate was 90% effective in preventing COVID-19 in study participants at 7 days after the second dose of the vaccine. 
  • Fewer than 10% of COVID-19 infections were in participants who had received the vaccine; more than 90% of the cases were in those who had received a placebo.  
  • No safety concerns were observed. 
  • The vaccine must be shipped and stored at ultra-cold temperatures, -94 F (-70 C), which may limit where the vaccine can be used.

Complete details of the trial and results are necessary to interpret reported findings. Further information is forthcoming.  

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