The Story Behind the FDA Approval of Pfizer’s Covid Vaccine

On 23^rd August, the United States Food and Drug Administration authorised the first COVID-19 vaccine. The vaccine was previously known as the Pfizer-BioNTech COVID-19 Vaccine. It will now be marketed under the brand name Comirnaty (koe-mir'-na-tee). The vaccine will be used for the prevention of COVID-19 disease in individuals 16 years of age and older.

Today, we'll go over some points which are pertaining with the USFDA's approval of Pfizer's Covid vaccine.

First and foremost, an introduction to the USFDA is required, even if most viewers of this channel are aware of this. The second, and probably more interesting, issue to consider is how long it typically takes for a medicine to be approved by the USFDA. The third and most significant topic to cover is the USFDA's drug development and approval process. Last but not least, does FDA approval guarantee the safety of a drug?

An Introduction to The USFDA:

The USFDA is a government regulatory agency within the U.S. Department of Health and Human Services.  The Center for Drug Evaluation and Research (CDER) is a science-led body under the United States Food and Drug Administration (FDA) which is in charge of reviewing the drug approval process before a drug is marketed. The CDER and FDA conduct a thorough examination of each drug with the help of an independent team of clinicians and scientists who assess the drug's safety, efficacy, and labelling. Following approval, the FDA continues to monitor new pharmaceutical products to ensure they remain safe and effective.

Before making a decision, the FDA does not test the medicine itself. However, as part of the approval procedure, the agency inspects the facility where the medicine would be made. Vaccines and biologics follow the same basic route as that of pharmaceuticals.

 How Long It Typically Takes For A Medicine To Be Approved By The USFDA:

The entire research, development, and approval procedure can take between 12 and 15 years. Only five compounds out of every 5,000 that undergo preclinical testing make it to human testing. Only one of these five compounds that goes through human trials is approved. According to the Tufts Center for the Study of Drug Development, it costs a manufacturer more than $2.6 billion to bring a new drug from the laboratory to the pharmacy shelf.

However, in 1992, the Prescription Drug User Fee Act (PDUFA) was passed in the United States, allowing the FDA to collect payments from corporations in order to speed the drug-approval process. According to the FDA, PDUFA has enabled the Food and Drug Administration to provide access to innovative drugs as quickly as or faster than anyplace else in the world. Since the passage of PDUFA in 1992, more than 1,000 medicines and biologics have entered into the market.

The act (PDUFA) establishes two approval timelines: (1) Standard Review and (2) Priority Review. The purpose of standard review is to complete the approval process for a medicine in 10 months. This type of evaluation is given to a medicine that provides little to no improvement over other therapies already available on the market. Priority review is a for medicines that produce significant advancements in treatment or provide treatment where no one previously existed. The FDA aims to complete the drug approval procedure in six months.

Furthermore, the FDA provides an accelerated approval pathway for selective medications which are used to treat serious and life-threatening conditions for which there is no suitable treatment. One disadvantage of the accelerated approval process is that it allows a New Drug Application to be granted before the drug's effectiveness are fully tested. This step is however normally required.

The Pfizer-BioNTech vaccine may have been licenced through this approach without being tested for efficacy. Virologists are concerned about the vaccine's unknown side effects and the perplexed durability assumption, in which no one can guarantee how long the vaccination will be effective in protecting against Covid-19. 

The USFDA's drug development and approval process.

Drug companies are constantly analysing thousands of chemicals in search of those with medicinal promise. The producer is known as preclinical testing which completes the drug's synthesis and purification and limited animal testing. Preclinical testing takes nearly six to seven years. Out of the 5,000 compounds evaluated, approximately five will appear promising enough. This will prompt the company to submit an Investigational New Drug Application (IND). If the IND is approved by the FDA and by an Institutional Review Board, the manufacturer may begin the first stage of development.

The IND stage comes next. The IND stage is divided into three phases. In phase I, clinical trials are undertaken with healthy people to determine the drug's basic characteristics and safety profile in humans. The medicine often remains in this stage for one to two years. In phase II, efficacy trials begin when the medicine is provided to volunteers from the target population. At the conclusion of phase II, the manufacturer meets with FDA officials to discuss the development process, ongoing human testing, any concerns the FDA may have, and the guidelines for phase III trial, which is often the most comprehensive and expensive stage of drug development. The IND stage lasts around seven years.

When phase III is completed, the manufacturer submits a New Drug Application (NDA). The NDA review process normally takes one to two years. The overall time for drug development and approval is around nine years (including the stages of IND and NDA). During the NDA stage, the FDA consults expert advisory committees to obtain a broader range of advice on drug safety, efficacy, and labelling. When the medicine is approved, it can be marketed with FDA-approved labelling. The FDA also collects safety data as the drug is taken and adverse events are recorded. FDA may seek modifications in labelling or issue statements in media when new contraindications emerge. If adverse effects appear to be systematic and serious, the FDA may withdraw a product from the market.

Here, I'd like to share some fascinating statistics with my readers. In 1980, the typical drug was subjected to thirty clinical trials involving approximately 1500 participants to get FDA’s approval. By the mid-1990s, the typical drug had to go through more than sixty clinical trials involving approximately 5,000 individuals. However, in the case of Pfizer's Covid vaccine, the FDA approved an Emergency Use Authorization (EUA) on December 11, 2020, based on only one clinical trial. To support the FDA's approval decision, the FDA reviewed updated data from the same clinical trial which supported the Emergency Use Authorization in December last year and included a longer duration follow up in a larger clinical trial population. As a result, it cannot be completely ruled out that the FDA's clearance of Pfizer's Covid vaccination was flawed.

Does FDA approval guarantee a drug's safety?

According to the FDA’s website, the Center for Drug Evaluation and Research (CDER) is to ensure that the drugs marketed in the United States of America are safe and effective. But, CDER does not test drugs. The Center’s Office of Testing and Research conducts limited research in the areas of drug quality, safety and effectiveness. It is the responsibility of the company to test a drug and submit evidence that it is safe and effective. Such data provided by the drug manufacturing company along with the proposed labelling are reviewed by a team of CDER physicians, scientists, chemists, pharmacologists and other scientists.

According to an article titled "Misplaced Trust" published in drugwatch, FDA approval does not guarantee safety. Critics say, Bif Pharma funds FDA reviews of new drugs, creating a conflict of interest. The agency is too focused on approving drugs to appease Big Pharma and it lacks the proper authority and funding to protect the public. 

It's now time to wrap up today's discussion. Those who were celebrating the FDA's approval of Pfizer's vaccine as a breakthrough in the fight against Covid-19 must have come to a halt after reading this.

@pradipsinterpretations