Pfizer vaccine gets full FDA OK
Approval sets stage for more Md. workplace and school mandates
With the U.S. Food and Drug Administration’s full approval of the first COVID19 vaccine Monday, the federal regulatory agency has set the stage for more immunization mandates in Maryland school systems, workplaces and businesses.
The long-anticipated decision, about eight months after the Pfizer/BioNTech messenger RNA vaccine received emergency use authorization by the FDA, approves the use of the vaccine in people age 16 and over. Kids 12 to 15 can still receive it under the agency’s emergency authorization provision, and younger children remain ineligible to receive any of the three vaccines available in the United States.
In Maryland, where the majority of the population already has received a vaccine, it’s not clear what effect full federal approval will have on persuading those who remain unvaccinated to roll up their sleeves. But approval, the final step in the FDA’s regulatory process, may convince more employers and private establishments to impose vaccine requirements, public health experts and business leaders said.
“Organizations and companies will feel comfortable mandating the vaccine now,” said Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security. “There are going to be certain people who
say this isn’t enough. But many also realize the value of the vaccine for workplace safety and resiliency.”
Maryland Gov. Larry Hogan suggested it may help overcome vaccine hesitancy as well.
“For people who are still hesitant about getting the vaccine, this is an assurance that it has met the most rigorous standards for
safety and effectiveness,” Hogan, a Republican, said in a statement.
Vaccine mandates already exist in Maryland hospitals, in skilled nursing facilities and for state employees. But elsewhere, the requirements have been set in piecemeal fashion, with some companies and businesses imposing mandates and many others not.
Several large organizations such as CareFirst BlueCross BlueShield, Catholic Charities and Miles & Stockbridge also have required vaccinations, recognizing the importance of client and customer safety, said Donald C. Fry, president and CEO of the Greater Baltimore Committee.
He said full approval comes at the right time, during a surge of sickness and death
overwhelmingly among those who are not vaccinated.
As of Monday, more than 3.6 million Marylanders had been fully vaccinated, including more than 80% of adults over 18. Nationally, about 73% of adults have received at least one dose of vaccine,
putting Maryland’s population well above average in its vaccine coverage.
But the state has not been immune from the summer surge of the virus. Infections, hospitalizations and the testing positivity rate, which fell to record lows in June and July, have since surged, fueled by the more contagious delta variant that the U.S. Centers for Disease Control and Prevention considers more adept at penetrating the vaccines’ protective shield. The CDC’s latest genomic surveillance data shows that nearly all U.S. COVID-19 cases are linked to delta now.
On Monday, Maryland health officials reported 925 new infections and that close to 700 people were being treated in hospitals across the state. The state’s positivity rate stood at just under 5%, the benchmark cited by the World Health Organization and others as indicating widespread transmission.
National public health professionals, including Dr. Anthony S. Fauci, the nation’s top infectious disease expert, initially called for as much as 80% to 85% of the population to get vaccinated to achieve herd immunity, or the threshold where the coronavirus runs out of viable hosts and stops spreading. But so long as pockets of Maryland and the country remain unvaccinated, the virus can continue to mutate into more contagious and deadlier strains.
“The more people who are vaccinated, the safer that Baltimore and every other community will be,” said Dr. Joshua M. Sharfstein, a former city health commissioner and state health secretary. “Outreach efforts remain incredibly important, and people should still have opportunities for their questions to be answered.”
National polling from the Kaiser Family Foundation in June shows that a significant level of confusion about the vaccines remains, especially among those who have not been inoculated already.
About one-third of all adults — and about half of those who said they will “wait and see” before getting vaccinated — said they would be more likely to get immunized if one of the vaccines then authorized for emergency use were to receive full approval from the FDA.
But polling also found that two-thirds of adults, including a large majority of unvaccinated adults, either believe the vaccines currently available in the U.S. already have full FDA approval or are unsure whether they have full approval or are authorized for emergency use.
Maryland State Del. Lauren Arikan, a Republican who represents parts of Baltimore and Harford counties, said full approval may not sway many of her constituents who already viewed the vaccines as rushed through the regulatory process.
“I’m not sure that having a fast-tracked approval is going to change what their concerns are, which is the lack of long-term safety data,” Arikan said. “They are questioning the entire program because they feel like there is clearly political involvement and control of science, and that is scary to them.”
The FDA continues to review and monitor vaccine data, particularly to further assess the potential effects of the vaccine during pregnancy and in infants, and how often it causes myocarditis and pericarditis, two rare heart conditions found in small numbers of vaccinated young adults.
Dr. Janet Woodcock, acting FDA commissioner, said full approval and the sheer volume of people who already have been immunized safely in clinical trials and in real-world settings are proof that the vaccines are safe.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Woodcock said in a statement.
More than half of the state and much of the country has received Pfizer’s two-dose vaccine series, including more than half of all vaccinated Marylanders. As of Monday, approximately 2,093,466 individuals have received a first dose of the Pfizer vaccine, according to the state health department.