Clinical

How far is too far when urgently developing a vaccine.

Hundreds and thousands of researchers are desperately trying to find a vaccine to Covid-19 and currently only 37 are in the testing stage. While 91 are in the preclinical phase. The question is how far and how should we balance safety and urgency of this vaccine. Even with working vaccines we would need at least a 50% success rate for the CDC to pass it to mass distribution. Rushing a vaccine is known to be dangerous and vaccines normally take several years to develop.

Russia is the first country to approve of their covid-19 vaccine but skipped a phase 3 trial. Phase 3 trials are important since they test the success rate with a bigger population. Although Russia offered their vaccines to be distributed internationally, due to the 3rd phase being skipped Russia received mass disapproval. Even with that in mind Russia began distributing their vaccines.

Although Russia is attempting to give everyone immunity by distributing these vaccines, there are a lot of harms that come with it. Unfinished vaccines that lack testing can be deadly and in some cases a waste of money. With better research, we can all benefit from this vaccine.

According to nytimes.com, Mr. Zimmer and Thomas explain the important of phase 3 trials.

“In such a trial, volunteers are randomly assigned to receive either the vaccine or the placebo. They don’t know which one they are given, nor do their doctors. By “blinding” the trial, researchers ensure that no bias creeps into the study.

A Phase 3 trial collects data about the symptoms volunteers experience after their injection, and whether they become infected with the coronavirus. After “unblinding” the data, researchers compare the rates of infection and adverse side effects between people who receive the vaccine and those who receive the placebo.

If significantly more people get Covid-19 on the placebo than the vaccine, that is evidence that the vaccine is effective. The F.D.A. has indicated that vaccine makers should aim for 50 percent protection in order to be considered effective.

If significantly more people who receive the vaccine suffer serious side effects, that may indicate that the vaccine isn’t safe — or may be safe only for certain groups, like people under the age of 65.”

With this information I believe that it is safe to say that phase 3 trials are important for the future of the human race. With better understanding of these tests and development of the vaccine everyone should keep masks on and stay 6 feet apart to prevent further spread.

Sources:

CNN – https://www.cnn.com/videos/world/2020/09/10/russia-coronavirus-covid-19-vaccine-sputnik-v-phase-three-exclusive-chance-pkg-intl-hnk-vpx.cnn

BBC- https://www.bbc.com/news/world-europe-54036221

NYT- https://www.nytimes.com/2020/09/09/learning/how-should-we-balance-safety-and-urgency-in-developing-a-covid-19-vaccine.html

Categories: Clinical