Worldwide, almost 50 COVID-19 vaccines are now in clinical trials. Below, we take look at five companies developing potential vaccines for the US market, all of which have entered either Phase 3 or combined Phase 2/3 clinical trials*.
How it works: The vaccine was developed using bioengineered spike proteins normally found on the surface of the SARS-CoV-2 membrane. These proteins are packaged into nanoparticles and administered twice, 21 days apart.
Phase: On September 24, Novavax announced that they would be entering Phase 3 clinical trials in the United Kingdom with 10,000 individuals (with or without underlying conditions). It also plans to initiate Phase 3 clinical trials in the United States in October.
Doses required: Two
Federal financial involvement: In July, the Department of Health and Human Services (HHS) awarded Novavax $1.6 billion to support the vaccine’s clinical trials and manufacturing.
Production plans: The company is expected to deliver 100 million doses to the United States by the start of 2021 if the vaccine is clinically proven to work.
Company: Johnson & Johnson
How it works: The vaccine uses a viral vector approach to introduce a piece of SARS-CoV-2 DNA into human cells. This DNA is packaged into an adenovirus – in this case the virus that causes the common cold – that has been genetically altered to prevent replication.
Phase: Johnson & Johnson began Phase 1/2 clinical trials in July and announced on September 23 that it would be initiating combined Phase 2/3 safety and efficacy trials in 60,000 adults from around the world. The trials include participants from older populations as well as those with underlying conditions.
Doses required: Just one and does not need to be kept frozen.
Federal financial involvement: In August, the federal government agreed to pay $1 billion for 100 million doses if the vaccine is approved.
Production plans: The company is aiming for production of at least a billion doses in 2021.
Company: Moderna Therapeutics
How it works: The vaccine uses a newly developed genetic approach. Snippets of messenger mRNA are injected into human cells, which then produce viral proteins that train the immune system to recognize and destroy SARS-CoV-2. This technology produces vaccines much quicker than older genetic methods, which required growing viruses in the lab.
Phase: In July, Moderna entered Phase 3 trials with 30,000 participants at 89 sites around the United States.
Doses required: Two, administered four weeks apart
Federal financial involvement: Moderna received an initial investment of $1 billion from HHS. In August they received an additional investment of $1.5 billion in exchange for 100 million doses should the vaccine prove to be safe and effective.
Production plans: Company executives said that they are on track to deliver at least 500 million doses per year beginning in 2021.
How it works: The vaccine uses mRNA technology.
Phase: Pfizer/BioNTech began Phase 2/3 trials involving 30,000 volunteers in the United States and other countries, including Argentina, Brazil, and Germany. On September 12, they announced they were planning on enrolling an additional 13,000 participants, for a total of 43,000.
Dose required: One
Federal financial involvement: The companies were awarded a $1.9 billion contract in late July to produce 100 million doses by December 2020.
Production plans: Executives believe they will know whether the vaccine works by October. If so, they expect to manufacture over 1.3 billion doses of their vaccine for worldwide distribution by the end of 2021.
Company: AstraZeneca/University of Oxford
How it works: This vaccine uses the viral-vector delivery approach similar to that of Johnson & Johnson. The vaccine employs a weakened version of the common cold-causing adenovirus. SARS-CoV-2 spike proteins are packaged into the adenovirus and delivered via injection to stimulate an immune response.
Phase: Results from Phase 1/2 trials published in July demonstrated that the vaccine produces a strong immune response in participants and had relatively mild side effects. They have since moved into combined Phase 2/3 trials with the goal of enrolling 50,000 participants in the UK, Brazil, India, South Africa, and the United States.
Dose required: Two
Federal financial involvement: They received a $1.2 billion investment from the United States in May.
Production plans: AstraZeneca/University of Oxford have reached an agreement with the European Union to deliver 400 million doses if approved.
To learn more about the race to stop the spread of the pandemic, download our white paper, Traveling at the speed of light: Health IT’s role in administering the COVID-19 vaccine.
*Disclaimer: Information about COVID-19 vaccine development is rapidly changing. Information above is current as of 10/21/2020.