The medical research instituitions and pharmaceutical industry have shown an outstanding performance by coming up with a COVID-19 vaccine within a year of the virus’s outbreak. This process, which usually takes approximately around 10 years, was completed even before the first anniversary of this pandemic. The first COVID-19 vaccine, which was developed by Russia, was launched in August last year. Russina President Vladimir Putin promoted the vaccine extensively by showcasing that his daughter was one of the first recepients of the vaccine. This fast-track approach to vaccine generation does cause a lot of questions in everyone’s mind. Can the thorough process of vaccine generation can or should be cut short? Is the vaccine safe? What about the potential long term side-effects of an accelerated process? To understand if the vaccine is safe or not we have to first understand the vaccine approval process.
Every vaccine has to go through a three-phase clinical trial before hitting the markets. This process ensures the safety and effectiveness of vaccines. All vaccines have to pass a number of tests before entering the human body. This includes numerous lab testing instances and animal trials. Only vaccines that look promising and safe in preventing the infection are sent forward for human trials. The first phase of clinical trials includes a very limited group of volunteers. Only willing people who pass an extreme health test involving physical exams and blood tests are chosen as volunteers. These volunteers are informed about the vaccine and its related risks. The ones who sign the information consent after getting all their doubts resolved by the researchers are given the first-ever vaccine shots. All these volunteers are kept under the supervision of a specialized medical team and are evaluated for health on a regular basis.
The researchers also have to inform the volunteers of any new information or update regarding their health or vaccine. A method used in the phase one trial is called the randomized, double blinded trial where a computer divides a group of volunteers into two groups. One group is given the vaccine while the other group is given placebo which is essentially just saltwater. This method helps to distinguish the side effects of the vaccine from the effects that are just happening to the people at the same time such as cold symptoms or headaches. The term double blind means that neither the researchers nor the study staff knows about the group getting the vaccine. This is necessary to prevent under and over reporting of symptoms by both the staff and patients. Phase one of the clinical trials of any vaccine can last as long as two years. Safety and tolerability of the vaccine are some key findings of this phase. The immune reaction of the human body is also reviewed this helps us to see if the vaccine has a promising approach for facing the specific virus. This phase does not conclude with the effectiveness of the vaccine towards our end goal which is building immunity against the virus.
Moving on to phase two of the clinical trials, this phase can last longer than two years and is basically to confirm the safety of the vaccine on a larger group of volunteers. It also helps the researchers understand the right timing and the best dose of vaccine to have optimal effects. Vaccines that are safe and produce a strong immune response move onto the third and final phase of clinical trials. This phase is to find out the rate of infection in both the placebo and vaccine groups. It also helps to identify any possible subgroups to which the vaccine might be limited to like young volunteers or female volunteers. This efficacy data collected in phase three of the clinical trial is essential for the vaccine to get FDA approval. The FDA and subcommittee of the centers for disease control and prevention also known as the ACIP (Advisory committee on immunization practice) are some of the approving bodies which the vaccine has to impress before stepping into the market. These approving bodies look at the results of the clinical trials to determine whether the vaccine should move forward or not. And if it should move forward then is it safe for the general population or just a part of it? Even after hitting the market, the vaccine is monitored for any side effects that might have been missed in all three phases of clinical trials. So, summing it all together even in the best case scenario it can take up to six to ten years for a vaccine to move from phase one testing to real world distribution.
Well, then does it mean the handful of vaccines that have gotten the approval and are being rolled out not safe for the public? Absolutely not! Since for COVID-19, we don’t have the luxury of waiting around for years for vaccines to be developed so what has happened is that many of these trials are running concurrently. In a general scenario a phase two of the clinical trial won’t start before phase one is completed, well analyzed, and recorded. Similarly, phase three won’t start before thoroughly studying the results of phase two. Apart from this, no pharmaceutical company would start the manufacturing process of vaccines at a large scale before getting all the approvals, but in this case of emergency, the vaccines are being made as the government reviews them. It is an essential risk that the government is willing to take to speed up the vaccine development process, and any vaccine that doesn’t get approval will be destroyed. People shouldn’t worry about the vaccine because of the speed with which they have been made. The SARS-CoV-2 virus that causes COVID-19 is a type of coronavirus. And because we knew a lot about coronaviruses beforehand we didn’t had to start from scratch while making vaccines and this saved us a lot of time. The main aim was to get a product available in the market as soon as possible even if we have to break some protocols. This product obviously should exceed in benefits than the potential risks and it should have a non-negligible minimum and essential safety requirements. For sure as time passes by we will be seeing a lot of new and hopefully strong vaccine candidates in the market. It obviously isn’t like anything is better than nothing. All these vaccines have undergone thorough examination and are our best shot as of now for fighting the virus.
Another important thing to note here is that more time, funding, knowledge, and people were made available to win over this virus as soon as possible. In a general case scenario, a vaccine is reviewed for the approval process only when all the trials are finished, but because of the shortage of time and urgency of vaccine, this process was running along by the approving bodies as soon as any new information was available. No new organizations or structures were formed for the approval process but the same committees were working together more closely to boost up the process. Same science same methods and the same committee just working in a more coordinated manner have saved us about tens of years. The classical process of making a vaccine has a snail’s pace but with proper management and multitasking like in the case of trials and approvals, one can cut short the time exponentially. Also, a lot of time is wasted in the volunteer selection process but surprisingly thousands of volunteers came forward to help us and take part in the COVID-19 vaccine studies and saved a lot of time, which in a case like this is equivalent to lives. With all these resources, selfless volunteers, researchers, and medical teams no vaccine is far away from us.
This explains how a near impossible task has been accomplished by researchers, pharmaceutical companies, medical teams, governments and international health organizations working in parallel to develop the COVID-19 vaccines within such a short span of time and under huge pressure. From all of this, we most definitely can be confident enough that any vaccine that hits the market has been reviewed extremely and if there were any safety concerns the vaccines would not have been released. Spreading rumors about the vaccine and talking negatively is the worst we can do at this crucial time. We should be thankful for all those who have done this impossible and should hope for the best.
-Priyanshi Mishra (Freelancer)
Picture Credits: sciencemag.org / BIONTECH