Instead of delivering pieces of virus, or proteins made by the virus grown from chicken eggs, RNA vaccines deliver a synthetically manufactured genetic blueprint that allows human cells to manufacture its own, harmless viral protein. The Moderna vaccine was already being administered in Phase 1 clinical trials a mere 10 weeks after the genetic sequence of the virus was released, and the Pfizer vaccine is now the first of its kind to be approved by the FDA. ![]() The greatest reason the first COVID-19 vaccines were developed so quickly is the type of molecule utilized in creating the vaccine: the Moderna and Pfizer SARS-CoV-2 vaccines are mRNA vaccines, vaccines that deliver a small molecule called messenger RNA, which encodes a gene for virus surface protein, to the host’s body cells. The Pfizer-BioNTech and Moderna vaccines. This is the technique used for the seasonal influenza vaccine. There was also evidence that neutralizing antibodies, antibodies that bind to a virus, preventing it from interacting with a host cell, are important to achieving coronavirus immunity.Įven with good prior knowledge of what viral antigens will provoke an immune response, traditional vaccine development takes six months to produce, treat, and purify virus grown inside fertilized chicken eggs. For example, there was abundant prior knowledge about the role of the viral spike protein, a glycoprotein antigen that allows the virus to enter cells, in other coronavirus diseases. What are some of the reasons behind this unusually short vaccine development timeline?īesides the emergency caused by the pandemic crisis, there are several factors that allowed researchers to develop a novel vaccine against Covid-19 much faster than typical. The Pfizer-BioNTech and Moderna vaccines developed for the SARS-CoV-2 virus approved for the treatment of Covid-19 took much less time to get to market (approximately 10 months from vaccine candidate identification to regulatory review and dispersal). After the completion of phase III, the United States Food and Drug Administration (FDA) must approve the vaccine based upon its safety and efficacy data.Įven the most expediently developed vaccines have taken 12-18 months to be created, tested, and approved. Each level of trial incorporates more study participants, as dosages are refined and safety data is collected. there are three phases of clinical (human) trials. Initial exploratory and pre-clinical (animal) studies can take up to eight years to complete. The first stage of vaccine development includes exploratory studies that can identify an antigen that could elicit a desirable immune response. Normal timeline for developing a vaccine to a novel disease. Food and Drug Administration (FDA) reviews the safety and efficacy of the vaccine before it can go to market.įigure 1. When all three phases have been completed, the U.S. In the U.S., there are three phases of human clinical trials: Phase 1.) the vaccine is given to small groups of people to test for safety and dosage Phase 2.) a broader array of the population receives the vaccine (hundreds of people) to further refine dosage, safety, and to test for immunogenicity and Phase 3.) thousands of people receive the vaccine and the vaccine is rigorously tested for efficacy against infection. ![]() These processes of vaccine development include exploratory research, pre-clinical testing, clinical trials, review and approval, manufacturing and quality control. ![]() Normally, the pre-market processes required to produce a vaccine for a novel disease take years to complete (Figure 1). Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.Molecules of Life: The Central Dogma and RNA Vaccinesĭevelopment of the SARS-CoV-2 mRNA vaccine Demographic Subgroup Information – COVID-19 Vaccine, mRNA (SPIKEVAX).For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
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