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A mix of legacy drugmakers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.
COVID-19, which was first detected in December in Wuhan, China, has sickened more than 194,000 people worldwide and killed at least 7,800. There are no Food and Drug Administration-approved vaccines or therapies for the disease.
In the U.S., the companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo. Other companies are funding trials by themselves or through partnerships with other life sciences companies.
Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:
Companies: BioNTech SE and Pfizer Inc.
Type: Vaccine
Stage: Preclinical
Name: BNT162
Background: On March 17, Pfizer announced that it would help develop and distribute BioNTech SE’s COVID-19 vaccine candidate, though the deal excludes China. BioNTech plans to put the vaccine candidate into clinical trials in late April, in Germany and the U.S. It is testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China. Pfizer and BioNTech for several years have said they would partner to develop mRNA-based influenza vaccines.
Year-to-date stock performances: Shares of BioNTech have soared 104%; Pfizer’s stock is down 20%.
Company: Gilead Sciences Inc. GILD, 8.418%
Type: Treatment
Stage: Phase 3 clinical trials
Name: remdesivir
Background: Gilead is a longtime drug maker that is best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine. Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild to moderate forms of pneumonia in people with the virus. The trial was given the go-ahead by China’s Food and Drug Administration in February.
Clinical trials:
1. On Feb. 21, the National Institute of Allergy and Infectious Diseases started enrolling patients in a randomized, double-blind, placebo-controlled Phase 3 trial evaluating 394 hospitalized patients with COVID-19 at up to 50 sites worldwide. The trial is expected to conclude April 1, 2023. Sites include the National Institutes of Health in Bethesda, Md., (not recruiting), the University of Nebraska Medical Center in Omaha (recruiting), the University of Texas Medical Branch in Galveston (not recruiting), and Providence Sacred Heart Medical Center in Spokane (recruiting).
2. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 600 patients with moderate COVID-19. The trial is expected to start enrolling patients in March, with results to come in May.
3. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 400 patients with severe COVID-19. The trial is expected to start enrolling patients in March, with results in May.
Year-to-date stock performance: Shares of Gilead are up 13.43%.
Company: GlaxoSmithKline GSK, 8.554%
Type: Pandemic adjuvant platform for vaccines
Name: AS03 Adjuvant System
Background: GSK is another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others. On Feb. 3, it said the CEPI-funded University of Queensland will have access to the British drugmaker’s vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. On Feb. 24, GSK said that Clover Biopharmaceuticals Inc., a Chinese biotechnology company, is also using adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.
Year-to-date stock performance: Shares of GSK have tumbled 23.46%.
A mix of legacy drugmakers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.
COVID-19, which was first detected in December in Wuhan, China, has sickened more than 194,000 people worldwide and killed at least 7,800. There are no Food and Drug Administration-approved vaccines or therapies for the disease.
In the U.S., the companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo. Other companies are funding trials by themselves or through partnerships with other life sciences companies.
Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:
Companies: BioNTech SE and Pfizer Inc.
Type: Vaccine
Stage: Preclinical
Name: BNT162
Background: On March 17, Pfizer announced that it would help develop and distribute BioNTech SE’s COVID-19 vaccine candidate, though the deal excludes China. BioNTech plans to put the vaccine candidate into clinical trials in late April, in Germany and the U.S. It is testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China. Pfizer and BioNTech for several years have said they would partner to develop mRNA-based influenza vaccines.
Year-to-date stock performances: Shares of BioNTech have soared 104%; Pfizer’s stock is down 20%.
Company: Gilead Sciences Inc. GILD, 8.418%
Type: Treatment
Stage: Phase 3 clinical trials
Name: remdesivir
Background: Gilead is a longtime drug maker that is best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine. Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild to moderate forms of pneumonia in people with the virus. The trial was given the go-ahead by China’s Food and Drug Administration in February.
Clinical trials:
1. On Feb. 21, the National Institute of Allergy and Infectious Diseases started enrolling patients in a randomized, double-blind, placebo-controlled Phase 3 trial evaluating 394 hospitalized patients with COVID-19 at up to 50 sites worldwide. The trial is expected to conclude April 1, 2023. Sites include the National Institutes of Health in Bethesda, Md., (not recruiting), the University of Nebraska Medical Center in Omaha (recruiting), the University of Texas Medical Branch in Galveston (not recruiting), and Providence Sacred Heart Medical Center in Spokane (recruiting).
2. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 600 patients with moderate COVID-19. The trial is expected to start enrolling patients in March, with results to come in May.
3. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 400 patients with severe COVID-19. The trial is expected to start enrolling patients in March, with results in May.
Year-to-date stock performance: Shares of Gilead are up 13.43%.
Company: GlaxoSmithKline GSK, 8.554%
Type: Pandemic adjuvant platform for vaccines
Name: AS03 Adjuvant System
Background: GSK is another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others. On Feb. 3, it said the CEPI-funded University of Queensland will have access to the British drugmaker’s vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. On Feb. 24, GSK said that Clover Biopharmaceuticals Inc., a Chinese biotechnology company, is also using adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.
Year-to-date stock performance: Shares of GSK have tumbled 23.46%.