(Reuters) – The COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE became the first to secure full approval from the U.S Food and Drug Administration on Monday, a move that is expected to help health authorities struggling to win over vaccine skeptics.
Following are a few comments from the President of the United States and public health experts:
U.S. PRESIDENT JOE BIDEN (on Twitter)
“The FDA has officially approved the Pfizer COVID-19 vaccine. While all three COVID vaccines have met FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective.”
“If you’re not vaccinated yet, now is the time.”
BARBARA ALEXANDER, PRESIDENT, INFECTIOUS DISEASES SOCIETY OF AMERICA
“Full FDA approval strengthens the case for vaccination requirements as an important strategy to curb infection and prevent hospitalizations and deaths due to COVID-19. The most important takeaway from today’s announcement is to get vaccinated.”
JESSE GOODMAN, INFECTIOUS DISEASE EXPERT AT GEORGETOWN UNIVERSITY & FORMER CHIEF SCIENTIST AT FDA
“I know some people are concerned that vaccines, including this one, can have adverse effects. What FDA is really saying is that the benefits far outweigh any risks.”
“The approval also allows doctors to legally prescribe additional doses of the vaccine to their patients, which some doctors have already been doing.”
“Some of these prescribing decisions may be appropriate, but I think it is really incumbent upon the FDA and the CDC and the CDC’s Advisory Committee on Immunization Practices to provide really good and strong guidelines while we’re still learning more about things like combinations of different vaccines.”
ERIC TOPOL, PROFESSOR OF MOLECULAR MEDICINE AND DIRECTOR OF THE SCRIPPS RESEARCH TRANSLATIONAL INSTITUTE
“Some companies, the military and some health systems did go ahead with mandates, but not nearly as many as will go forward now. Many large employers will go ahead and require vaccination because they were waiting for the magic word of full approval instead of emergency use authorization.”
“It will help many who are hesitant. Obviously, there was a large proportion of Americans who were concerned when it was viewed as an emergency, rather than a fully blessed, sanctioned, approved vaccine. I think that at both levels, there will be a surge of vaccinations in the weeks ahead.”
AMERICAN ACADEMY OF PEDIATRICS
“While this (the approval for use in people aged 16 and above) means it is legally permissible for physicians to administer the vaccine off-label for children aged 11 and younger, who currently have no available vaccine, the American Academy of Pediatrics strongly discourages that practice.”
“The clinical trials for the COVID-19 vaccine in children aged 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children”
AMERICAN MEDICAL ASSOCIATION
“Today’s news marks a critical moment for people who were concerned about getting vaccinated due to the vaccines being authorized for emergency use. FDA approval also should further reinforce efforts in the health care field to urge vaccination, and to deploy all reasonable tools to achieve high levels of vaccination, including mandatory vaccination policies”
PAUL OFFIT, UNIVERSITY OF PENNSYLVANIA, MEMBER OF FDA’S VACCINE ADVISORY PANEL
“What the FDA has now said is that the vaccine that they have basically licensed not just the product, but also the manufacturing site and the process by which the product is made.”
DOCTORS WITHOUT BORDERS/MÉDECINS SANS FRONTIÈRES (MSF)
“Following today’s approval, MSF is calling on Pfizer and BioNTech to share the vaccine technology and knowledge with manufacturers on the African continent that could help boost the global supply.
(Reporting by Mrinalika Roy in Bengaluru and Julie Steenhuysen in Chicago; Editing by Shinjini Ganguli)
