Drugmaker Pfizer, which has its global vaccine research and development headquarters in Rockland County, announced on Nov. 9 that its Covid-19 vaccine candidate was more than 90% effective in preventing coronavirus in trial volunteers.
“Today is a great day for science and humanity. The first set of results from our Phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine”™s ability to prevent Covid-19,” Pfizer Chairman and CEO Dr. Albert Bourla said.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.”
Also the same day, President-elect Joe Biden”™s transition team announced the formation of a coronavirus task force.
Coronavirus deaths reported in the U.S. have topped 237,000, according to Johns Hopkins University and Medicine. Global deaths attributed to Covid-19 were surpassing 1.3 million.
Pfizer developed the vaccine with BioNTech SE of Germany, whose co-founder and CEO Ugur Sahin said in a statement, “This is a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve.”
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of Nov. 8, according to Pfizer.
About 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is currently enrolling and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued, according to Pfizer.
Bourla said in an update posted on the company website: “It”™s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.
“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate ”“ required by FDA”™s guidance for potential Emergency Use Authorization ”“ will be available by the third week of November.”
He said, “Efficacy, safety and consistent manufacturing are the three requirements that are needed before we are able to file for authorization.”
In addition, participants in the vaccine trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” Bourla said.
Pfizer and BioNTech also plan to submit data from the full Phase 3 trial for scientific peer-review publication.
Rockland County Executive Ed Day said, “I am so proud of the work being done by Pfizer right here in Rockland County. This announcement is extremely promising for our country and the entire world, if the results hold up then the end of the coronavirus pandemic could be in sight. In the meantime, please continue to social distance, wear masks if you can’t, wash your hands and stay home if you’re sick. We will get through this together.”
In Washington, D.C., Biden’s transition team said its Covid-19 advisory board is made up of:
CO-CHAIRS
Dr. David Kessler
Kessler is professor of pediatrics and epidemiology and biostatistics at the University of California at San Francisco. Kessler served as FDA commissioner from 1990 to 1997, appointed by President George H.W. Bush and reappointed by President Bill Clinton.
Dr. Vivek Murthy
Murthy served as the 19th surgeon general of the United States from 2014-17. As the vice admiral of the U.S. Public Health Service Commissioned Corps, he commanded a uniformed service of 6,600 public health officers globally.
Dr. Marcella Nunez-Smith
Nunez-Smith is an associate professor of internal medicine, public health, and management at Yale University and the associate dean for health equity research at the Yale School of Medicine. Her research focuses on promoting health and health care equity for structurally marginalized populations.
MEMBERS
Dr. Luciana Borio
Borio is vice president, technical staff at In-Q-Tel.
Rick Bright
Bright is an American immunologist, virologist and former public health official. He was the director of the Biomedical Advanced Research and Development Authority from 2016 to 2020 and the deputy assistant secretary for preparedness and response at the Department of Health and Human Services.
Dr. Ezekiel Emanuel
Emanuel is an oncologist and vice provost for global initiatives and chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.
Dr. Atul Gawande
Gawande is the Cyndy and John Fish Distinguished Professor of Surgery at Brigham and Women”™s Hospital, Samuel O. Thier Professor of Surgery at Harvard Medical School, and professor of health policy and management at Harvard T.H. Chan School of Public Health.
Dr. Celine Gounder
Gounder is a clinical assistant professor at the NYU Grossman School of Medicine and cares for patients at Bellevue Hospital Center.
Dr. Julie Morita
Morita is executive vice president of the Robert Wood Johnson Foundation.
Michael Osterholm
Osterholm is regents professor, McKnight Presidential Endowed Chair in Public Health and the director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Loyce Pace
Pace is the executive director and president of Global Health Council.
Dr. Robert Rodriguez
Rodriguez graduated from Harvard Medical School and currently serves as a professor of emergency medicine at the UCSF School of Medicine, where he works on the frontline in the emergency department and ICU of two major trauma centers.
Dr. Eric Goosby
Goosby is an internationally recognized expert on infectious diseases and Professor of Medicine at the UCSF School of Medicine. During the Clinton administration, Goosby was the founding director of the Ryan White CARE Act, the largest federally funded HIV/AIDS program.
