With coronavirus infections and deaths mounting in the United States, the race to find vaccines is accelerating. Here’s a rundown of how this process is taking shape, and the key results expected in the coming months.
Moderna’s mRNA vaccine
It took just 63 days from the time the company started designing its vaccine to launch the first clinical trial, a rapid pace made possible in part by Moderna’s use of genetic material called messenger RNA. When that mRNA is injected into a patient, it directs cells to make a protein found on the coronavirus — and stimulates the production of antibodies.
No mRNA vaccine for any disease has yet won approval, but the technique has tantalized public health experts because churning out doses using this technology would be cheaper and easier than making traditional vaccines. The U.S. government’s Biomedical Advanced Research and Development Authority has pledged up to $483 million to accelerate the Moderna vaccine’s path to FDA approval.
Scientists at the Kaiser Permanente Washington Health Research Institute in Seattle and Emory University in Atlanta began enrolling patients in a 45-person Phase I safety trial in March. Participants received two shots of the experimental vaccine approximately one month apart and will be followed for about a year.
In May, Moderna said that eight patients in the trial had developed antibodies to the coronavirus. The full results of the study haven’t been published.
Later that month the company began a Phase II trial aimed at determining whether the vaccine works. A Phase III trial could beginin July. If the early data is promising, the company says it could churn out enough doses by next fall to vaccinate health care workers and other priority groups.
CanSino Biologics and Beijing Institute of Biotechnology vaccine
This experimental vaccine, developed in China, was created to combat Ebola. It uses an inactivated version of a virus that causes the common cold to carry a gene that causes cells to make a protein found on the coronavirus — with the goal of sparking an immune response.
The vaccine was the first to move into Phase I testing, in March, and published promising results in May. A Phase II trial began in April.
CanSino inked an agreement in May with Canada’s National Research Council to scale up production at a government facility in Montreal and hopes to conduct clinical trials in Canada.
In June, the company said that China’s Central Military Commission would allow the country’s military to give the vaccine to soldiers for a period of one year, based on the unpublished Phase II trial results.
Johnson & Johnson, Beth Israel Deaconess Medical Center and BARDA vaccine
Johnson & Johnson is working with the Biomedical Advanced Research and Development Authority and Boston-based Beth Israel Deaconess Medical Center on a vaccine that uses an inactivated version of the common-cold virus to carry genetic material into cells. That material prompts the body to pump out proteins found in the coronavirus in the hopes of drawing an immune response. The company plans to start combined Phase I/II trials in July. If the vaccine works, J&J says the first batches could be available for emergency use in early 2021.
Pfizer and BioNTech vaccine
The two companies — one American, one German — are partnering on an mRNA coronavirus vaccine. German regulators approved a Phase I/II trial of the vaccine in April, and the vaccine began a Phase I trial in the U.S. in May. Pfizer is paying BioNTech $185 million upfront as part of the collaboration, and the companies said they have the potential to supply millions of doses by the end of 2020 if the vaccine is promising, and scale up to produce hundreds of millions of doses in 2021.
Sanofi and GlaxoSmithKline vaccine
This experimental vaccine combines Sanofi technology that produces a protein found in the coronavirus, which aims to trigger an immune response, with an adjuvant made by GlaxoSmithKline designed to heighten that immune response. The companies plan to begin Phase I trials of their vaccine in the second half of the year, and if the results look good, a vaccine could be available by the second half of 2021. Phase I clinical trials are expected to begin in the second half of 2020 and, if successful, a vaccine could be available by the second half of 2021.
University of Oxford and AstraZeneca vaccine
The British university and drug company are teaming up on a vaccine that — like the CanSino Biologics candidate — is based on a weakened version of the common cold that contains some genetic material from the coronavirus. The Oxford vaccine entered a Phase I clinical trial at five sites in England in late April, and since moved into a combined Phase II/III trial there and Phase III studies in South Africa and Brazil.
The vaccine’s backers were able to launch large-scale trials quickly based on data from earlier safety tests of similar vaccines, including one last year designed to target a different coronavirus.
The vaccine from China-based Sinovac is made of a purified, inactivated coronavirus and it uses an adjuvant from Dynavax, which the California company uses in its own Hepatitis B vaccine. In mid-June, the company released results from a Phase II trial that found the vaccine prompted the development of neutralizing antibodies in more than 90% of participants.
Sinovac has said it’s building manufacturing capacity to produce as many as 100 million doses if the vaccine proves effective.