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How vaccines get made and approved in the US

  • Vaccines and Related Biological Products Advisory Committee

    The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) sets the regulatory pathway to permit wide-scale use of a vaccine and can slow down the process when it feels necessary. At the end of October, the VRBPAC held a nine-hour virtual meeting to discuss the regulatory pathway, at the end of which it told the FDA to slow down the process of trying to get a COVID-19 vaccine out so rapidly.

  • Manufacturing investigation

    Before a vaccine can be used in the United States, the FDA must conduct a manufacturing investigation, where scientists and medical professionals investigate how the vaccine is manufactured in order to make sure it can be made consistently in a safe, pure, and potent manner. This includes inspecting manufacturing sites to ensure that they comply with regulations.

  • FDA approval

    It is after all the aforementioned steps are carried out that a vaccine can gain FDA approval. This process can easily take a year, and in the case of quick-moving and especially destructive diseases, such as COVID-19, some may feel that it does not move quickly enough. In that case, there is the possibility to make a vaccine available more quickly, through FDA Emergency Use Authorization.

  • FDA Emergency Use Authorization

    Emergency Use Authorization (EUA) allows the FDA to make unapproved products, such as drug treatments or vaccines, available for use during public health emergencies. However, an EUA has never been used to administer a vaccine to civilians. This is because while drug treatments are generally given to people who are already ill, vaccines are given to people who are still healthy, so the bar for using them is much higher. In the case of COVID-19, the FDA has been considering criteria for deploying a vaccine initially under the EUA.

  • Vaccine supply chain

    While the vaccines themselves are vital, they are only useful when they can get to the people who need them. That is where the vaccine supply chain comes in. Getting vaccines to millions of people requires effective vaccine handling, storage, and stock management, as well as rigorous temperature control and well-kept information systems.

     

  • Vaccine distribution

    In the case of COVID-19, the severity of the virus makes it especially important to get the vaccine out to as many people as quickly as possible. In the United States, states are already developing vaccine distribution plans, which deal with questions of vaccine storage, data tracking, and looking at who will pay for the vaccine to be deployed and how to make sure it is done in an equitable way.

  • Vaccine marketing

    Along with the challenges of making and distributing a vaccine, it can also be a challenge to convince people that the vaccine is safe and effective so that they will agree to get it. Before COVID-19, there was already a strong anti-vaccine movement in the United States, and science skepticism and misinformation are causing people to be wary of forthcoming COVID-19 vaccines.

  • Post-marketing surveillance

    Also known as a phase 4 trial, post-marketing surveillance is done once the drug is already marketed and available to the general public. This phase checks the vaccine’s performance in real life scenarios, studies the long-term risks and benefits, and potentially uncovers rare side effects.

  • Adverse events

    In the event of an adverse reaction to a vaccine, the CDC and FDA co-manage the Vaccine Adverse Event Reporting System (VAERS). This national early warning system accepts and analyzes reports of possible negative side effects after a person has received a vaccine. Anyone can report to VAERS.

  • Herd immunity

    Herd immunity happens when a virus stops spreading because it continuously encounters people who are protected against infection. This is the ultimate aim of wide-scale vaccination programs. In this case, the vaccine protects those who are vaccinated, and herd immunity protects those who are unable to be vaccinated, for example those with compromised immune systems. The unvaccinated people become less vulnerable, because the odds that they will come into contact with an infected person decrease dramatically.

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