The Boston Globe highlights COVID-19 vaccines in development, including the vaccine currently in development as part of a partnership between Johnson & Johnson and the Center for Virology and Vaccine Research at BIDMC, led by Dan Barouch, MD, PhD (Center for Virology and Vaccine Research, BIDMC).
Boston Globe – July 9, 2020
11 coronavirus vaccines to keep an eye on
Federal officials have repeatedly expressed optimism that at least one vaccine against the coronavirus will be proven effective and ready for market by early 2021. As of this week, pharmaceutical companies worldwide were working on 160 candidates, including 21 that are being tested in people, according to the World Health Organization.
The biggest splash this week came from Novavax, a Maryland company that landed $1.6 billion from the US government’s Operation Warp Speed program to support manufacturing and clinical trials for its vaccine candidate.
At least three key clinical studies are expected to begin later this month: Moderna’s new trial of its experimental vaccine, which would be the largest study to date in the United States; Pfizer’s expansion of its trials with German firm BioNTech; and Johnson & Johnson’s first trial in humans, working with a group at Beth Israel Deaconess Medical Center.
Each prospective vaccine goes through three phases of study in humans. To speed the process, some vaccine developers are conducting two of the phases simultaneously. Here’s an overview of each phase:
Phase 1: Trials involve small numbers of people, testing whether the vaccine is safe and provokes an immune response.
Phase 2: Trials expand to hundreds of people, comparing the vaccine’s effects in different groups and further testing its safety.
Phase 3: Trials enroll many thousands of people, to see if those who receive the vaccine are less likely to become infected than those who receive a placebo.
Below is a small subset of notable vaccine candidates that we believe are of most interest to our readers. The list is not meant to be comprehensive or to indicate any likelihood of success. Rather, it reflects a snapshot of companies and efforts that have ties to New England; that have major funding behind them and the ability to move markets; and that reflect a diversity of approaches.
Here are 11 coronavirus vaccine efforts to watch
Moderna (Cambridge)
Status of clinical trials: Expected to start Phase 3 trials in July.
Funding and approach: The project has received $483 million from the federal Biomedical Advanced Research and Development Authority. The Moderna technology — called messenger RNA — inserts portions of the virus’s RNA into cells, which then manufacture a piece of the virus to trigger an immune response. The company set a drug industry record by producing its vaccine in 42 days after receiving the genetic sequence of the virus that causes COVID-19.
Johnson & Johnson (New Brunswick, N.J.)
Status of clinical trials: Testing in people (Phase 1) to begin in July.
Funding and approach: The company developed the vaccine with the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. The vaccine uses a common-cold virus to deliver part of the coronavirus into cells to stimulate the immune system to fight off an infection. J&J and BARDA have invested more than $1 billion in the effort.
AstraZeneca (Cambridge, England)
Status of clinical trials: Phase 2/3 in the United Kingdom.
Funding and approach: In a partnership with the University of Oxford, the British-Swedish company has developed a vaccine that uses a weakened version of a common-cold virus to deliver coronavirus genes into cells to provoke an immune response. BARDA has provided more than $1 billion in funding.
Sanofi and GSK (Paris and London)
Status of clinical trials: Testing in people (Phase 1) to begin in September.
Funding and approach: The vaccine candidate builds on work the French drug giant did in the SARS epidemic and employs technology Sanofi used in one of its flu vaccines. Sanofi is using one of GSK’s proprietary adjuvants, an ingredient for vaccines that can create stronger and longer-lasting immunity. BARDA has provided $30 million in funding.
Merck (Kenilworth, N.J.)
Status of clinical trials: Testing in people (Phase 1) to start later this year.
Funding and approach: The drug giant is partnering with the nonprofit IAVI on a coronavirus vaccine related to the company’s existing Ebola vaccine. BARDA has provided $38 million.
Pfizer (New York City)
Status of clinical trials: Phase 1/2 in the United States and Europe, with plans to begin Phase 2b/3 in late July.
Funding and approach: Collaborating with the German firm BioNTech, Pfizer is deploying technology that appears similar to Moderna’s: a messenger RNA vaccine that codes for the spike protein found on the surface of the coronavirus. Pfizer agreed to pay BioNTech $185 million upfront, and BioNTech has a debt financing agreement with the European Investment Bank.
Sinovac Biotech (Beijing)
Status of clinical trials: Phase 3 trials in Brazil have started.
Funding and approach: The Sinovac vaccine, called CoronaVac, uses a whole coronavirus that has been inactivated, so that it will trigger an immune response without causing illness. Unlike most of the other vaccine candidates under study, this is a proven vaccine method. But such vaccines, which must be grown in cultures, take longer to manufacture than those based on the virus’s genetic material. This spring, Sinovac received $15 million in private investment, as well as an $8.5 million loan from the Bank of Beijing.
Novartis (Basel, Switzerland)
Status of clinical trials: Testing in people (Phase 1) to start later this year.
Funding and approach: A subsidiary of the Swiss pharmaceutical giant Novartis is collaborating with Massachusetts Eye and Ear and Massachusetts General Hospital on a vaccine that uses a harmless virus as a Trojan horse to deliver the genetic sequence of the coronavirus into human cells to produce an immune response. The collaboration has received a $1 million donation from Boston Celtics co-owner Wyc Grousbeck.
Sanofi and Translate Bio (Paris and Lexington, Mass.)
Status of clinical trials: Not yet being tested in people.
Funding and approach: The companies are collaborating on messenger RNA vaccines in a partnership that expands on a 2018 deal to develop such vaccines for as many as five infectious diseases. Translate specializes in developing mRNA medicines. Sanofi is paying Translate $425 million up front. The companies hope to start a trial of a coronavirus vaccine in the fourth quarter.
CureVac (Tubingen, Germany)
Status of clinical trials: Phase 1 in Germany and Belgium.
Funding and approach: The firm, which has about 20 employees at its US hub in Boston, has received an $85 million loan from the lending arm of the European Union to expand manufacturing for a vaccine candidate that relies on messenger RNA. The company also received a grant of up to $8.3 million from the Coalition for Epidemic Preparedness Innovations.
Novavax (Gaithersburg, Md.)
Status of clinical trials: Phase 1/2 in Australia and United States, with plans to begin Phase 3 later this year.
Funding and approach: The company is expanding its manufacturing capacity and pursuing late-stage clinical trials. Its vaccine candidate uses protein nanoparticles, together with a proprietary compound, to generate and enhance the immune response. The firm has been awarded $1.6 billion by the US government’s Operation Warp Speed, and previously received $388 million from the Coalition for Epidemic Preparedness Innovations.
