The Latest News on the Search for a COVID-19 Vaccine
by Kroger Health Staff
Last Updated: April 12, 2020
Researchers across the United States and the world are racing to find a vaccine for COVID-19, a novel coronavirus that started spreading in late 2019. While containment strategies have helped slow the spread of COVID-19, a vaccine enables people to develop immunity without becoming sick.
What is the process to develop this vaccine?
Around January 10, Chinese scientists sequenced and shared the full genetic code of SARS-Cov2, commonly called COVID-19. Researchers around the world are using this genetic code to produce elements of the virus, which form the basis for a vaccine. You may already know that a vaccine works by sparking an immune response to fight off infection. When creating a brand new vaccine, there are several steps that researchers undergo to ensure that the vaccine works effectively and safely. The first is to determine if the vaccine formulation can cause an immune response. Next, tests are conducted to ensure the ingredients are safe and will not cause harm to humans. Once researchers are confident that the vaccine is safe for use and able to generate an immune response, it undergoes testing for overall effectiveness against the disease it is intended to prevent.
When will a vaccine be available?
Vaccine development requires a multi-stage process to test safety and effectiveness, gain FDA approval, and become available to the public. This process typically takes about ten years, but governments and regulatory bodies globally are expediting this process while maintaining safety standards, in light of the current pandemic. Current estimates place vaccine availability 12-18 months from now, though this timeframe may evolve.
What is the current status?
Currently, there are dozens of vaccine candidates globally being investigated for potential use. Only a small handful of these have reached clinical trials so far. Although COVID-19 was sequenced in January 2020, the speed of modern technology and expedited regulatory processes has enabled companies to enter clinical trials in a matter of months instead of years.
How long do clinical trials take?
Clinical trials for vaccines start with a small study in Phase 1. Although typically lasting one to two years, this is expected to take three months to complete for COVID-19. Phases 2 and 3 can be run simultaneously for COVID-19, testing larger sample sizes (thousands of participants) to determine optimal dosage, effective schedule, safety, and effectiveness. These phases are expected to take eight months, instead of the typical two to four years. Following Phase 3, there is a federal regulatory review that combs through all the clinical trial data and decides whether to approve the vaccine. Normally lasting one to two years, this is expected to be completed in a few months for COVID-19. Finally, Phase 4 involves post-approval studies that monitor effectiveness as the vaccine is deployed to the public. It is too early to tell if any of the current vaccine candidates will be approved and the exact time frame involved.
What happens after a vaccine is approved?
After approval, there is a final step involving the scaling of vaccine production. Although vaccines can be mass-produced before FDA approval, the manufacturer takes a risk that approval will not come or the vaccine is no longer needed. To fund the potentially large number of vaccines required and encourage manufacturing, companies, governments, and international organizations are working together to pool resources and mitigate risk. This ensures vaccines are available in sufficient quantities to address the global need.
Disclaimer: The information in this story is accurate as of its publication. However, the situation surrounding COVID-19 is ever-evolving. We are working to keep our stories up-to-date as changes occur, but we also encourage everyone to check news and recommendations from the CDC, WHO, and their local authorities.