Vaccine Release and Plans
As cases surge amid states’ phased reopening, fear of never being able to return to normal has perhaps never been more prevalent or relevant. Despite having flattened the curve before America’s rash phased reopening, with the use of things like N95 respirators , we’ve only slowed the virus. Experts have confirmed that stopping it will certainly require herd immunity, for which a vaccine may well be our only hope. Reopening may not be the only thing happening in phases, though -- experts working on developing a vaccine immunization for the novel coronavirus SARS-CoV-2 say that the urgent need for a vaccine, coupled with the intense and rigorous hoops to jump through for testing and development of the drug may necessitate phased releases of a vaccine.
The development for a coronavirus vaccine is on an accelerated path for approval, and under significant pressure to deliver a viable immunization by January of the year 2021. At present time, immunologists are unsure of whether that will in fact be even possible. While they rush to develop the vaccine on an expedited schedule, though, they may be forced to release the vaccine in phases, as different versions of it complete the phased testing and development required by the Food and Drug Administration (FDA).
What would this look like? Well, vaccines can be developed using several different methods, all of which require nearly 2 years of development, testing, lab work, and distribution to become fully available on the market as a fully FDA approved new drug. As the development for a coronavirus vaccine is under significant time restraints due to the urgency of the present, unprecedented times, researchers may not be able to fully flesh out and explore which of the possible methods yields the most safe and effective vaccine. Therefore, we may see different versions of coronavirus vaccines developed and released as they clear tests and restrictions. THis would mean the release of a first version, that is the first developed and cleared for administration, which would be good enough to be FDA approved and better than nothing. This initial version would be made available the quickest. As scientists continues to explore other methods and develop other options and versions of the coronavirus vaccine that worked better, had fewer side effects, were cheaper to manufacture, etc., we would see subsequent versions released.
While all this may seem disconcerting, Paula Cannon, Distinguished Professor of Molecular Microbiology and Immunology at the Keck School of Medicine of USC, upholds the importance of the vaccine in the current crisis, saying, “The early vaccines may have some limitations, but they will provide much more protection than we have now and it will be full steam ahead to distribute it far and wide. We shouldn’t allow the perfect to be the enemy of the good.”
So how close are we to a Version 1 vaccine meeting approval? Well, vaccine development runs its own course, but the testing comes in 5 distinct phases.
First is the preclinical phase, which entails the research and development of possible vaccines that are then tested on animals or in labs. Currently, there are upwards of 145 possible vaccines in the preclinical stage around the world.
Next is Phase 1, which approves vaccine testing for safety and possible dosage in humans. It’s administered to a very small number of test subjects, and monitored to see the effects in immune system stimulation. Currently, there are 15 possible vaccines in Phase 1.
Then there is Phase 2, which expands vaccine use in safety trials. Phase 2 aims to further confirm a vaccine’s aptitude for immune system stimulation, and is administered to hundreds of people split into groups, often along age lines such as children and the elderly. There are 10 developing vaccines currently in Phase 2 trials. Due to the urgent need for the vaccine, some developers have combined Phases 1 and 2, testing the vaccine for the first time on hundreds of subjects.
Our last stop is Phase 3, which is the lengthiest part of the process and the one researchers have said they are absolutely unwilling to rush or compromise on in the race to develop a vaccine for the novel coronavirus SARS-CoV-2. Phase 3 entails large-scale efficacy tests, which involve injecting large numbers of subjects with the vaccine, and another large number with a placebo, and then seeing what could possibly go wrong. For Phase 3 trials in the United States, the trial will involve 30,000 people, with half getting the vaccine and the other half receiving the placebo. Then, researchers will wait and see how many people get sick after inoculation with the vaccine and how many with the placebo. Meanwhile, researchers also monitor possible side effects, while also comparing numbers between those infected in the vaccine arm and those infected in the placebo arm. 4 vaccines are currently in Phase 3 of development.
The last step is approval. During this phase, regulators review the vaccine and its trial results, and decide whether or not to approve its safety in their country. Different countries have different drug regulations. This process may be warped during a pandemic, allowing for emergency use authorization before the vaccine is formally approved. As of right now, only one vaccine has limited approval -- a Chinese-developed vaccine based on an adenovirus. Phase 1 yielded positive results for the vaccine, and unpublished results from Phase 2 testing upheld the vaccine’s ability to significantly stimulate the immune system. The Chinese military therefore approved the vaccine for a year on June 25 as a “specialty needed drug.”
Not bypassing phases, vaccine development and administration by January of 2021 will be a marvel of modern science. Even if accomplished, to administer billions of the vaccine swiftly may be yet impossible. Companies are continuing toward not only development, but manufacture of possible drugs, so that as soon as approval hits, millions of injections can be distributed and administered as swiftly as possible. Even in the best scenario, a few million doses will be available by the end of 2020 at very soonest, and will then beprioritized and given
to the people who need it most. The rest of us will wait with baited breath behind masks for a safe and effective vaccine in 2021.