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SALT LAKE CITY — A Utah doctor is pleading with vaccine-hesitant Utahns who were awaiting approval from the Food and Drug Administration to live up to their word and get the shot now that Pfizer's vaccine has been approved.
"For those who are waiting to be vaccinated, now is the time to get it," Dr. Tamara Sheffield, medical director of community health and prevention at Intermountain Healthcare, said in a news conference Monday.
The Pfizer vaccine has been available under an emergency use authorization from the FDA since Dec. 11, 2020, for people ages 16 and above and since May 10 for ages 12 through 15. However, some people across the country have been hesitant to receive the vaccine until it received official approval from the administration.
The FDA gave final approval to Pfizer's COVID-19 vaccine Monday. The U.S. is the first country to give the vaccine, now marketed under the brand name Comirnaty, full approval. Reuters reported that the process required a 360,000-page application and rigorous inspections; the FDA has never before had so much evidence to judge a vaccine's safety.
What has changed in order for the drug to be approved? Essentially nothing, Sheffield said Monday. The data and information are the same as they were before the approval announcement, she explained, it just had to go through an analysis process to show that the drug's effects and side effects have been reviewed and the benefits largely outweigh the known and potential risks.
Reviewers have ensured the drug meets the FDA's rigorous standards for safety, effectiveness and manufacturing quality.
How does a drug product get FDA approval?
After a drug is developed, it is tested on animals. Once that testing demonstrates favorable results, the company has to apply for approval for human testing. That testing takes places in phases, unless it is expedited because of emergency circumstances. Even the accelerated process is highly rigorous.
During phase one, the drug is tested on 20 to 80 healthy human volunteers. Phase two involves hundreds of people of varying health status, half of whom are given a placebo, and reviewers study the short-term side effects closely. Thousands of volunteers are tested in phase three, which looks at how the drug affects different populations and how it might behave when combined with other drugs.
In the case of Pfizer's COVID-19 vaccine, the FDA analyzed effectiveness data from 40,000 people — 20,000 with the vaccine and 20,000 with a placebo. After receiving their second dose, the participants were monitored for side effects and safety outcomes for at least four months, and 12,000 have been followed at least six months.
Once the trials are done, the FDA holds a review meeting with the company, and the company submits an application with all of the data that the administration then reviews. Then the labelling of the drug, including known side effects and warnings, is discussed and reviewers inspect the facility where the drug is manufactured. After all that, the drug is finally approved, and even then, it is closely monitored through MedWatch, a voluntary reporting program for patients.
And while the intended effects of Comirnaty have outlasted all study phases, the vaccine will be labeled with information about rare risks of myocarditis and pericarditis.
What do FDA reviewers look for during the authorization process?
Scientists analyze the condition or illness, in this case COVID-19, and the current available treatments. They take into consideration the severity and spread of the disease and any issues that might arise from incomplete data. During the process the drugmaker must submit data from the phased clinical trials. These results allow the FDA to make decisions about whether or not a drug should be approved for marketing.
The reviewers examine:
- The drug's effectiveness.
- The dosage and frequency of doses in the trials.
- Any side effects and how they can be managed.
- How it is broken down in the body and how long it stays.
- Which food, drinks or other drugs are compatible or incompatible with the drug.
The clinical trial showed Pfizer's vaccine was 91% effective in preventing COVID-19 disease.
What is the difference between emergency use authorization and this full approval?
The FDA can issue emergency use authorizations to have unapproved medical products more readily available to treat or prevent serious illness in public emergency situations. However, just because something is not yet approved in these situations does not mean that it is unsafe. It may be, as in the case with COVID-19 vaccines, that there just hasn't been enough time to fully evaluate the data as closely as the government would like to. Emergency use authorizations still require strict criteria to be met, including that there are "no other adequate and/or approved alternatives available," according to the FDA website.
Clinical trials were used to evaluate investigational COVID-19 vaccines in tens of thousands of study participants, to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are conducted according to the rigorous standards set forth by the FDA.
"The vaccine has been proven to be safe and highly effective since it first became available under emergency use last December. Full FDA approval is the final step in a rigorous approval process to confirm the vaccine's safety and effectiveness," the Utah Department of Health said in a statement Monday, adding that it "should provide confidence to anyone who may have hesitated to get the vaccine while it was under emergency use."
"We strongly encourage you to get vaccinated and help end the pandemic. We also strongly encourage health care providers who haven't offered COVID-19 vaccines at their practice before now, to take the necessary steps to enroll as vaccine providers as soon as possible," the statement continued.
"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said acting FDA Commissioner Dr. Janet Woodcock. "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."
"While millions of people have already safely received COVID-19 vaccines, we recognize that, for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," she said. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."
Who are the scientists reviewing the data?
According to the FDA, "career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases" have reviewed Pfizer's data. They are human beings with lives and loved ones of their own.
"FDA staff are like your family — they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States," the FDA reports.
What are the side effects, according to the data?
"The most commonly reported side effects by clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death," the FDA said in a statement about Monday's approval of the Pfizer-BioNTech vaccine.
"Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age, compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes."
What does this mean for Utah?
"As of today, more than 200 million Americans have received a dose of a COVID-19 vaccine. That includes nearly 1.8 million Utahns," the Utah Department of Health said on Monday.
Although the health department has not tracked if there has been an uptick in vaccinations following Monday's announcement, Sheffield said there probably would be and that there is "plenty of supply set aside" for anyone who wants to be vaccinated — now that the drug is officially approved. Health care organizations throughout Utah will continue to give all three vaccines.
Intermountain Healthcare will not yet be requiring vaccination for its employees, Sheffield said, saying that it would need community and legislative support to make a mandate.
"For us, it's really looking at all the considerations. We are making sure that the community is supportive of that and that we have legislative support," she said. "We want to make sure that our employees are given every opportunity to make these decisions in a considered manner."
But mostly, she hopes Utahns are recognizing the urgency and that this approval will boost their confidence in the evidence that the vaccine works and is safe.
"It's a plea we're putting out to individuals to do everything you can to mitigate the spread. We need your help to help you," Sheffield said.