In November 2019, the first case of coronavirus infection occurred in China. Later the COVID-19 turned into a worldwide pandemic situation affecting everything or everyone in one way or another. To control the situation, scientists and researchers work with different research institutions, biotechnological, and pharmaceutical companies to formulate a cure.
Formulation of four vaccines across the globe occurred, yet these vaccines are under the process of clinical trials. Once they pass all phases of clinical trials with a positive response, the companies will apply for allowing their emergency usage to the FDA. The Food and Drug Administration will determine whether the coronavirus vaccine is suitable or not by analyzing the safety and efficacy profiles.
COVID-19 Vaccine By Moderna and Pfizer
Coronavirus vaccine is the one that will provide immunity against coronavirus to its users. Pfizer is an American multinational pharmaceutical corporation. It is one of the largest pharmaceutical companies. Pfizer is working with BioNTech to formulate a vaccine for coronavirus.
The vaccine formulated by Pfizer and BioNTech is 90% effective as per the data of the clinical phase 3 investigations. Albert Bourla is the CEO of Pfizer, and according to him, the company is collecting sufficient information on their coronavirus vaccine so that they can submit an application and get approval from the U.S. Food and Drug Administration for emergency use authorization.
Moderna is an American biotechnology company based in Cambridge, Massachusetts. Moderna also formulates a COVID-19 vaccine that is 94.5% effective according to its phase 3 clinical trials. The modern vaccine for coronavirus is easy to transport as it does not require ultra-cold storage conditions. Additionally, Moderna will soon apply for an emergency approval from the FDA after gathering more information this month.
According to Dr. Anthony Fauci, Americans will start getting vaccinated by the end of December. Moreover, the FDA is organizing meetings of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for 8th, 9th, and 10th December. By the end of these meetings, the member will make a final decision about approving the COVID-19 vaccine for emergency usage.
FDA AND CDC Parts In Vaccine Formulation And Usage
The FDA stands for the Food and Drug Administration. It is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs. Similarly, it is responsible for the safety, efficacy, and security of biological products, vaccines, and other food items. When the formation of a new drug occurs, the formulator receives approval from the FDA after every step. For example, a drug or vaccine formulator has to apply to investigating a new drug before beginning the process of formulation.
After gathering enough information about the physical characteristics of excipients and active ingredient application for approval of animal experimentation is gathered from FDA. Similarly, after every clinical trial, the information collected by investigations is submitted to move forward into the next step.
Currently, the FDA is working with U.S. government partners, including the CDC, and international partners, to control the COVID-19 pandemics. Once the FDA approves the coronavirus vaccine, the Centers for Disease Control’s Advisory Committee on Immunization Practices, consisting of an independent panel of experts, will meet within 24 to 48 hours. The CDC will review the data and determine who shall receive the vaccine first or who shall avoid vaccination.
The formulators of coronavirus-vaccine have made 40 million vaccine-doses. These doses can vaccinate 20 million individuals, as two doses are utilized by one person, with a few weeks gap. After ACIP issues a recommendation to use the vaccine, the companies will distribute the vaccine doses as per the instruction of authorities. However, the first to receive the vaccine is likely to be health care workers. Later, others, including police officers and those with underlying medical conditions, will receive the vaccination.