- Executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer told Congress the FDA hasn't eased its usual requirements for proving their vaccines are safe and effective.
- They said they should be able to produce a safe and effective vaccine by early 2021.
Drug company executives insisted Tuesday they aren't cutting corners in fast-tracking development of potential vaccines to prevent infection of the coronavirus.
Executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer told Congress the Food and Drug Administration hasn't eased its requirements for proving their vaccines are safe and effective. They also said they should be able to produce a safe and effective vaccine by the end of the year or early 2021.
"I think the guidelines the FDA have issued are absolutely to the normal standards and I think that if we are able to meet them, we will have a safe and efficacious vaccine," Dr. Mene Pangalos, AstraZeneca executive vice president for biopharmaceuticals research and development, said during a hearing with the House Energy and Commerce Committee on efforts to create a vaccine. "There's nothing that gives me pause that they're lowering their standards in any way."
Public health officials say there is no returning to "normal" until there is a vaccine.
There are no FDA-approved drugs or vaccines for the coronavirus, which has infected more than 14.7 million people worldwide and killed at least 610,560 as of Tuesday, according to data compiled by Johns Hopkins University. More than 100 potential vaccines are being developed worldwide, according to the World Health Organization, with at least 23 already in human trials.
It's a record-breaking time frame for a process that normally takes about a decade to develop an effective and safe vaccine. The fastest-ever vaccine development, mumps, took more than four years and was licensed in 1967.
But according to a poll from the Associated Press-NORC Center for Public Affairs Research, only about half of Americans say they would get a coronavirus vaccine if scientists succeed in making one that works. Among Americans who say they wouldn't get vaccinated, 7 in 10 worry about safety, according to the poll.
Dr. Julie Gerberding, executive vice president and chief patient officer at Merck, emphasized that there are still some safety concerns that scientists have to watch out for, including "enhancement of the respiratory disease under this kind of immunologic pressure."
"I think while we are fully prepared to move as quickly as we can through the things we can do in parallel, and gearing up for manufacturing now at risk, we do not expect to be able to accelerate the safety assessment and in fact we're quite relieved that the FDA insisted upon applying the same high standards of safety and efficacy even under these emergency conditions and that they would apply to any of the vaccines that we've" produced in the past, Gerberding said.
Health regulators have fast-tracked approvals for coronavirus research and development, allowing scientists to skip through months of red tape and to ramp up manufacturing before receiving regulatory approval. Because of the pandemic, health officials, drug companies and researchers have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.
While the vaccine may be safe, the executives told Congress that it is "understandable" that the public would be concerned, adding they will need to work to gain that trust.
"Vaccine hesitancy is probably one of the greatest challenges for public health that America faces," said John Young, the chief business officer at Pfizer. "All of us need to play a role, should we be successful in this mission, that there's confidence in the safety and effectiveness of our vaccines based on data, based on confidence the FDA will only approve a vaccine if it's safe and effective."
In the U.S., Black people continue to make up a disproportionate share of Covid-19 fatalities, according to U.S. data.
Conditions such as diabetes, hypertension and asthma that tend to plague African Americans more than other racial groups could be contributing to more Covid-19 deaths. Income inequalities and disparities in access to health care, which generally lead to poorer diets and overall health, tend to hurt minority and lower-income populations more than others.
The executives said it will be critical to work with the U.S. Department of Health and Human Services to get the vaccine to people who are most at risk.
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