Story at a glance
- Several companies testing vaccine candidates have reported early phase results suggesting safety and immune response.
- A few are currently in phase three clinical trials, the largest and last trial to test for efficacy and look for less common negative effects.
Here’s a look at where coronavirus vaccine efforts in the U.S. currently stand.
AstraZeneca and Oxford University
This vaccine candidate is in phase three trials in the U.K. and U.S. It is a chimpanzee adenovirus-vectored vaccine that contains genetic material that codes for a protein on the surface of SARS-CoV-2, the coronavirus that causes COVID-19. It is thought to work by getting cells to produce the protein, and then the body’s immune cells respond to the protein by producing antibodies.
Phase one/two trials in the U.K. suggest that it is safe and induces an immune response. On Sept. 8, phase three trials were paused because a trial participant in the U.K. was reported to potentially have had an adverse reaction. “Standard review process triggered a pause to vaccination to allow review of safety data,” according to a statement received by STAT.
The researchers have yet to determine whether the adverse reaction was caused by the vaccine candidate. “This ought to be reassuring,” says director of the National Institutes of Health Francis Collins before a Senate committee, according to the Associated Press. “When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.” The patient is expected to recover, reports STAT. Enrollment in the phase three trial began in the U.S. on Aug. 31.
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BioNTech and Pfizer
Germany company BioNTech has developed several mRNA vaccine candidates for the coronavirus. For phase two and three trials, it has narrowed down to one candidate named BNT162b2 with trials in Argentina, Brazil and the U.S. The company states that the vaccine could be ready by mid-October or early November, although there is still a lot to learn about the vaccine candidate. It’s currently in phase two/three clinical trials with participants ranging in age from 18 to 85 years old.
California-based Moderna has developed a synthetic messenger RNA (mRNA) vaccine candidate that encodes for a surface protein on the novel coronavirus. Phase three trials are currently ongoing in the U.S. The vaccine is reported to show promising results in older adults who participated in the trials and is currently in phase three clinical trials. The company recently slowed down enrollment in trials to ensure that minorities and older adults are represented. Black and Latinx people made up 15 percent of participants in mid-August.
Instead of focusing on mRNA, Inovio works on DNA vaccines. Its coronavirus vaccine is based on the genetic material of the virus. Early clinical trials showed immune responses in 34 out of 36 participants. It received a $71 million contract with the U.S. Department of Defense in June to scale manufacturing of its vaccine. The company is planning to start phase three trials for its vaccine later this month.
Johnson & Johnson
The company’s vaccine is reported to provide immune protection when tested in monkeys and prevents severe illness in hamsters. They plan to start phase three clinical trials in humans this month, aiming to recruit 60,000 participants. The vaccine candidate is a combination of genetic material from the novel coronavirus and a modified adenovirus.
Results from phase one/two trials of Novavax’s vaccine candidate, NVX-CoV2373, suggest that it is safe and produces an immune response after two doses. The company is conducting efficacy trials in South Africa. “Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373,” says Gregory M. Glenn, who is president of Research and Development at Novavax, according to a statement. The trial is funded by the Bill & Melinda Gates Foundation.
Sanofi and GlaxoSmithKline
The Paris-based Sanofi and London-based GlaxoSmithKline have developed a vaccine candidate that uses the same approach as Sanofi’s flu vaccine. The process starts by taking genetic material for a SARS-CoV-2 surface protein and inserting it into an insect cell. The cell produces the protein which is then purified.
The phase one/two clinical trials for this vaccine candidate will include 440 people in the U.S. and aims to determine whether the vaccine is safe and induces an immune response. The trials will take place in 11 sites across the country. The companies hope to be able to release results by December and phase three trials could begin before the end of the year.
For up-to-date information about COVID-19, check the websites of the Centers for Disease Control and Prevention and the World Health Organization. For updated global case counts, check this page maintained by Johns Hopkins University.
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