In developing new medicines, pharmaceutical companies have to undergo a long process with the use of advanced technology. The goal is to produce medicine that has the desired efficacy with the least side effects, if any. This is not just to pass the standards and gain the approval of the U.S. Food and Drug Administration (FDA).
Pharmaceutical companies need to ensure that their products are just as effective, if not more effective, than those of their competitors. They must also ensure that there will be no complaints or product recalls that will affect their brand’s reputation and, therefore, all their other products.
The Development Process for Medicines
According to the April 2021 Research and Development in the Pharmaceutical Industry report of the Congressional Budget Office, pharmaceutical companies spend on research and development for medicines based on three factors. One is the expected long-term global profits from the medicine. Next is the estimated cost of development for the medicine. The third is the existence of programs and policies that will affect the medicine’s supply and demand.
Pharmaceutical industries are focused on profit because they also have high risks in developing new medicines. Research and development for a new medicine can take decades, during which the company does not earn from it. They can spend from one to two billion dollars for every medication. This includes laboratory research and the need for several large clinical trials. Many of these medicines do not reach the market for several reasons. Some do not pass muster after laboratory tests. Some fail in the clinical trials. Among those that pass clinical trials, only about 12 percent gain FDA approval.
Pharmaceutical research and development have several areas. There is the research and discovery of new medicine. There is also the development process in the laboratory which includes testing the effective dosage of the active ingredient and designing the most appropriate delivery forms. United States Pharmacopeia or USP dissolution testing equipment is used to test the release of the medicine’s active ingredient and its bioavailability in the body. Several clinical tests are then conducted. These trials do not just test the medicine’s efficacy, but also compare it with competitors’ medicines. Side effects are also closely monitored.
Once the medicine passes the clinical trials, its production process is designed. This can have several processes if the medicine will come in different forms such as capsules and injectables. Only then are applications for approval submitted to the FDA.
Emergency Use Authorization
During the pandemic, the FDA gave emergency use authorization (EUA) to three COVID-19 vaccines. The Pfizer BioNTech vaccine was given its EUA on December 11, 2020. The Moderna vaccine received its EUA on December 18. The EUA for the Johnson & Johnson Covid 19 vaccine was given on February 26, 2021.
The EUA is given to enable the distribution of certain medicines or vaccines for the diagnosis, treatment, or prevention of life-threatening illnesses in public health emergencies like a pandemic. This is for products that have not yet received full approval. Among the criteria for issuing EUAs is the lack of fully approved alternatives.
The development of the COVID-19 vaccines was fast-tracked and rapid compared to the many years it usually takes to develop a new vaccine. The FDA explained that in the face of the pandemic, the government used its powers to bring together pharmaceutical companies, academe, nonprofit organizations, international agencies, and U.S. government agencies to speed up the development of vaccines to prevent the spread of COVID-19.
The U.S. government also made financial investments in the manufacturing setups for the vaccines to enable immediate mass production. All of these were done while ensuring that scientific standards were complied with for safety.
To receive the EUA, a COVID-19 vaccine manufacturer must submit the results of three phases of clinical trials. The third phase must include more than 3,000 recipients of the vaccine and they must have been monitored for adverse effects for a minimum of one month after being fully vaccinated. The FDA analyzes whether the benefits of the vaccine outweigh any potential risks. The FDA also checks on the manufacturing process to ensure consistently high quality.
The Final Approval Process
On August 23, 2021, the FDA fully approved the Pfizer-BioNTech COVID-19 Vaccine for use by people aged 16 and older. The product will be known in the market as Comirnaty.
Earning full approval means that the manufacturer’s submitted biologics license application (BLA) has passed the FDA’s analysis. The BLA provides more extensive data that supports and expands on previous submissions in the EUA application. Even after full approval, the FDA requires the manufacturer to continue clinical trials and market monitoring for any side effects of the vaccine.