PHILADELPHIA (KYW Newsradio) — COVID-19 vaccines have been in various states of approval for nearly a full year, and headlines about vaccines and boosters and other treatments seem to come weekly.
"CDC approves COVID-19 shots for kids 5-11; doses fast-tracked for release"
"FDA panel endorses Moderna booster, but not full shot"
"NJ-based Merck asks FDA to authorize use of its antiviral pill against COVID-19"
According to the CDC, Americans have received more than 423 million doses of some variety of COVID-19 vaccine. That's more than 191 million people inoculated against the virus.
So ... are the vaccines approved or not? What's the difference between CDC recommendation and FDA approval? And wait a second: Merck has a pill? And now Pfizer does, too?
Let's break it down.
Generally speaking, three COVID-19 vaccines — from Pfizer/BioNTech, Moderna and Johnson & Johnson — are authorized by the Food and Drug Administration for emergency use in the United States for people aged 12 and older.
As of Nov. 2, the Pfizer vaccine has full approval by the FDA for use on Americans age 5 and up.
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There are three phases for every vaccine developed in the United States.
1. FDA authorization
Vaccine development requires a long, complex process that can last as long as 10 or 15 years. Before full approval, some vaccines may be granted an emergency use authorization, or EUA, if the Secretary of Health and Human Services deems it appropriate and the shot has met rigorous, science-based standards.
This means, after the FDA reviews clinical data from pharmaceutical companies to evaluate safety and efficacy, the agency can authorize the use of unapproved medical products or procedures to protect the population in an emergency — as long as there is no adequate alternative already available.
How did it happen so fast? Research on coronaviruses — such as MERS, SARS and the common cold — was happening years before COVID-19 struck. Scientists were able to develop vaccines for the new coronavirus relatively quickly because of that foundational work.
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In 2020, it was clear that COVID-19 was a rapidly growing global threat, so the FDA fast-tracked work with drugmakers, labs and universities and nonprofits on analyzing huge amounts of data about potential vaccines.
That data showed certain vaccines to be effective with very low risk of serious side effects. The EUA allowed people to be protected against grave illness and death early, while the approval process continued.
2. CDC Recommendation
After the EUA is issued, the independent Advisory Committee on Immunization Practices (ACIP) reviews the data and votes whether to give their thumbs-up to the vaccine. If all goes well, their recommendation and guidance moves on to the director of the Centers for Disease Control and Prevention (CDC) for review.
3. FDA Approval
When the FDA approves a vaccine, it must undergo the agency's standard approval process for reviewing its safety and effectiveness. Full approval is granted when, over time, the FDA has collected even more evidence to support use of a vaccine.
The FDA reviews the manufacturing process to ensure that it can be produced reliably and with consistent quality. And the agency's Center for Drug Evaluation and Research analyses the risks and benefits to the people who have gotten the shot already.
After nearly 200 million people have received a COVID-19 vaccine, the FDA has a lot of information to go on.
After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
Before FDA approval
The development cycle of a vaccine goes like this:
Exploratory stage: basic lab research, lasting as long as two to four years.
Pre-clinical studies: a year or two of private industry research using tissue cultures and animal testing to assess the safety of a vaccine and get a sense of the potential response in humans. Many vaccines fail to progress beyond this stage.
Phase I clinical trials: a first attempt at assessing the vaccine in humans using a small (20-80) group of adults. If the vaccine will be used for children, researchers will first test it in adults, and then gradually step down the age of the test subjects.
This is why we have seen the approval of COVID-19 vaccines for various age groups happen separately. Also, early on, the most urgent need was for older adults and those with certain pre-existing conditions. Children were much less likely than adults to be harmed by the disease.
Phase II clinical trials: using a larger group of several hundred participants, including people in groups at higher risk of getting sick.
Phase III clinical trials: randomized and double blind testing of a vaccine on thousands to tens of thousands of people against a placebo. Certain rare side effects are more likely to come to light in this phase.
Many vaccines undergo ongoing Phase IV clinical studies after the vaccine is approved and licensed.
Timeline of COVID-19 vaccine distribution in the U.S.
Dec. 11, 2020: FDA issues the first EUA for the Pfizer vaccine in people 16 and older.
Dec. 14, 2020: The first deliveries of the Pfizer vaccines begin.
Dec. 18, 2020: FDA issues the second EUA for the Moderna vaccine in people 18 and older.
Feb. 27, 2021: FDA issues the third EUA for the Johnson & Johnson vaccine in people 18 and older.
May 10, 2021: FDA amends the EUA for the Pfizer vaccine to include kids 12-15.
Aug. 13, 2021: The CDC's Advisory Committee on Immunization Practices votes unanimously to recommend a third dose of the Pfizer or Moderna vaccines for a select group of immunocompromised people.
Aug. 23, 2021: FDA gives first full approval to the Pfizer vaccine in people 16 and older. The vaccine continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age.
Sept. 17, 2021: FDA advisory committee votes against recommending a widespread booster shot for the Pfizer vaccine, but the agency give the green light to use it for groups of at-risk people, including the elderly, people with compromised immune systems, and health care workers.
Sept. 23, 2021: The CDC advisory panel backs Pfizer's booster shot for older and high-risk Americans.
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Oct. 11, 2021: Merck submits an application to the FDA for an EUA for its first-of-its-kind antiviral pill to treat cases of COVID-19.
Oct. 14, 2021: The FDA's advisory committee endorses Moderna's booster shot for seniors and at-risk adults.
Oct. 20, 2021: The FDA authorizes an approach that will allow vaccinated people in certain categories to get booster shots from Moderna, Pfizer or Johnson & Johnson at least six months after completing the primary vaccination.
Oct. 29, 2021: The FDA authorizes emergency use of the Pfizer vaccine for kids 5 to 11 years old. The CDC issues its recommendations for distribution on Nov 2.
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Why so many layers of debate and approval? Let's look at history
By the end of the 19th century, vaccines for smallpox, rabies, cholera and typhoid had been developed, but there were no standards for vaccine production.
An outbreak of tetanus in 1901 from a contaminated smallpox vaccine in Camden -- as well as contaminated batches of a diphtheria antitoxin in St. Louis -- did a lot to pique public concern about pharmaceutical safety.
On July 1, 1902, Congress passed what became known as the Biologics Control Act "to regulate the sale of viruses, serums, toxins, and analogous products." It established the U.S. government's right and responsibility to control who made vaccines and how they made them.
To oversee drugmaking, the Act created the Hygienic Laboratory of the U.S. Public Health Service -- which eventually became the National Institutes of Health.
The United States Public Service Act of 1944 made it a requirement for drugmakers to seek and obtain licenses for products such as vaccines from the federal government. The Division of Biologics Standards -- now know as the Center for Biologics Evaluation and Research, and part of the FDA -- was created to address safety concerns.
The current system for creating, testing and regulating vaccines continued to develop over the course of the 20th century as the government agencies involved began to standardize their procedures.