After a year of more than 1.7 million deaths and multiple blockages, many people welcome the news that COVID-19 vaccines are starting to be released to the public. Large-scale vaccination may mean that life can return to pre-pandemic normalcy, however, this scenario depends on people’s willingness to get a job.
Some people are concerned about the safety of vaccines in general, while others are suspicious about the novelty and speed of the rapid return of COVID vaccines in particular. We asked 14 experts in immunology, biostatistics and vaccinology if COVID-19 vaccines are safe.
What COVID-19 vaccines have been approved and what does that mean?
Vaccines, along with all other medicines, cannot be used until a country approves them. This approval process is carried out in each country or group of countries by an independent agency.
In the US this is done by the FDA (Food and Drug Administration), in the UK by the MHRA (Medicines and Healthcare products Regulatory Agency) and in the European Union EMA (European Medicines Agency).
For anything to be approved by these agencies, it must show that it is 1) safe and 2) does what it is meant to do.
There are numerous COVID-19 vaccines under research and development. Although some of them are already used in Russia and China, only two vaccines are currently approved in the US and Canada.
One is a joint effort of Pfizer and BioNTech called “BNT162b2” and one is manufactured by Moderna and called “mRNA-1273”. BNT162b2 has been approved in 9 countries around the world, including the UK and is also licensed by the EMA.
How is a vaccine approved?
In order for Pfizer and Moderna vaccines to be approved by the above-mentioned agencies, they must have been shown to be safe. The safety data that are examined during the approval process cover each stage of the vaccine journey, from the initial laboratory experiments to the manufacturing process.
An important part of these data is clinical trials. All medicines, including vaccines, go through three stages of clinical trials:
- Step I ~ test the vaccine on a small group of volunteers (20-80) to check its safety and find the right dose
- Stage II ~ find out if the vaccine actually works by dividing 100-300 volunteers into two groups and giving one group the vaccine and the other group a placebo.
- Stage III ~ randomly divides thousands of volunteers into a vaccine group and a placebo group. Do not tell volunteers or doctors who is in which group (this is called a “double-blind” process) and check if the vaccine works and if there are any side effects.
If a study is not successful, for example, the results show that the vaccine does not effectively prevent the disease or cause side effects, the process is stopped and the vaccine is not approved.
Even after the vaccine has been approved, it then enters Phase IV, where it continues to be monitored and information on side effects is collected. This is important to determine if there are very rare effects, for example, at a chance of 1 in 100,000,000.
For example, two people in the UK had an allergic reaction to the Pfizer vaccine after receiving thousands. This sometimes happens in response to flu vaccines, and health care workers are ready to deal with such reactions when they set foot.
Both people have fully recovered, but gathering information on this is useful, for example, the UK has now issued precautionary advice to people with severe allergies.
Dr. Olivera Finn of the University of Pittsburgh explains that “all new vaccines continue to be monitored once they begin to be widely distributed. We are now well connected with the whole world, so a single vaccine problem anywhere in the world will cause rapid examination and changes if warranted. “
What safety data is there?
Both Pfizer and Moderna vaccines underwent all three clinical trials and found no serious side effects from their vaccines.
For the Pfizer vaccine, 195 people were recruited in the Phase I study in the US and 456 were included in the Phase II study in Germany. In both studies, no one who received the vaccine had any serious side effects. Pfizer’s Phase III process was published in a peer-reviewed journal and included more than 40,000 volunteers at 152 sites around the world.
In this process, the volunteers were divided into two groups. One group was given two placebo shots 21 days apart, and one group was given the real vaccines. This means that, in the end, 18,566 people received the 2 complete doses of vaccine.
For 14 weeks after the second jab, all 18,366 volunteers were evaluated for side effects, both by surveys and by taking blood samples. After the second jab, only 0.8 percent of them had a fever. More common symptoms were pain at the injection site and sometimes muscle and headache.
Professor Rick Kennedy of the Mayo Clinic explains that “the vast majority of observed side effects were expected and are a direct result of the immune response to the vaccine. The side effects are similar to those seen in most other authorized vaccines and ores that occur. at similar rates and with similar severity levels (mostly mild and moderate). “No one in the study had a severe reaction to the vaccine.
An important factor is that this phase III study included people from diverse backgrounds: 49% were women and 37% were black, African American or Hispanic. In addition, the study included people who might be at a higher level of risk: 35% of participants were obese, 21% had at least one coexisting condition, and the average age of the volunteers was 52 years.
The Moderna vaccine similarly included 120 people in their phase I study and 600 people in their phase II study. Although not all Phase III data is still available to the public (approving agencies have access), it included 30,000 people with a demographic diversity and saw no severe side effects.
All of the above information is available free of charge for anyone to read. In addition, the regulatory agencies that approved these two vaccines had access to more data covering not only clinical trials but also laboratory and animal studies. This information often has more than 10,000 pages and is carefully examined by the FDA, MHRA and EMA.
What is in COVID vaccines?
Moderna and Pfizer vaccines are RNA vaccines. RNA is the information in the SARS-CoV-2 virus that encodes all machines in the virus.
Traditional vaccines use a dead or modified version of the virus to cause the body to create an immune response, so it learns to recognize this virus and therefore becomes immune to it. RNA vaccines use a modified version of SARS-CoV-2 virus RNA.
When RNA enters your cells, the cells produce your own fragments of the virus, which then teaches your body to become immune like any other vaccine. RNA itself is not harmful, in fact your cells produce and use RNA all the time.
As Professor Crotty of the La Jolle Institute of Immunology explains, “At any given time a human cell has over 5,000 different RNA messages and they are all temporary messages, such as post-it notes that are broken by cells within minutes or hours. what was read. “
The vaccine RNA is broken down within one day of injection. Importantly, vaccines contain only a small section of RNA, “the message of RNA is for a single coronavirus protein. It takes 25 different coronavirus proteins to make a coronavirus, so there is no concern that RNA produces a virus.
RNA is packaged in small fat balls called lipid nanoparticles. These lipids are broken down and eliminated by your cells. The other ingredients are water and some salts and sugars to keep these particles stable.
This technology of releasing RNA by lipid nanoparticles has not been used so far for vaccines. However, drugs using lipid nanoparticles (called “nanomedicines”) have been used since the 1990s, and to date more than 20 different drugs have been approved by the FDA or EMA. Some of these drugs are based on RNA, similar to RNA vaccines. They are usually used for cancer and gene therapies.
How come the vaccines were made so quickly?
Vaccines usually take years to develop and produce. COVID-19 vaccines have lasted less than a year. This is due to a number of reasons, three of which are explained by Dr. Robert Carnahan of Vanderbilt University Medical Center:
“One, all vaccines … were manufactured ‘at risk.’ This means that they were produced before the completion of the clinical trials. This would never happen in a normal situation. Many of these costs have been borne by various government organizations around. Therefore, once emergency approval has been secured, distribution could begin.
Second, vaccine developers quickly analyzed the data as it came out and communicated this in real time to the various regulatory agencies. There are often gaps between months and years between different phases of clinical trials due only to these activities.
Third, recruitment to clinical trials is often a slow and laborious process. There must be people at “risk” for the disease in many different demographic and health categories. Due to the huge purpose of the pandemic, finding enough and appropriate volunteers was quick. “
Importantly, the speed did not affect the clinical trials and safety aspects of the trial: “The size, soundness and complexity of the clinical trials performed for current COVID-19 vaccines were no different from traditional clinical trials. They are as safe as vaccines and interventions have developed much slower. “- says Dr. Carnahan.
A balance of risk
Nothing in medicine is 100% safe – do not take medicine for a disease you do not have or a vaccine against a disease that does not exist.
Dr. William Hausdorff of PATH, a global nonprofit public health organization, explains that “all discussions about the“ safety ”of vaccines (or drugs in general) should start with discussions about how serious and common the condition you are trying is. to prevent or treat it If the condition is very minor, then even trivial side effects may not be worth it. If the condition is very serious, then people will accept much greater potential side effects. “
Every medical intervention is a risk-benefit balance. Both Pfizer and Moderna vaccines have shown> 90% efficacy in protecting individuals from COVID-19 in their Phase III clinical trials. This protection against a virus that has so far caused more than 1.7 million deaths globally is also an important issue when we think about vaccine safety.
Takeaway
All 14 experts agreed with the scientific consensus that COVID vaccines that have been approved by appropriate regulatory agencies, such as the FDA, are as safe as any other vaccine or drug.
Nothing in medicine is risky, and the decision to get a vaccine is personal and depends on a person’s individual circumstances.
Article based on 14 expert answers to this question: Are COVID-19 vaccines safe?
This expert response was published in partnership with the independent fact-finding platform Metafact.io. Subscribe here to the weekly newsletter.