For those who have doubts: 6 facts about a coronavirus vaccine

Federal officials hope to have 20 million vaccinated by the end of this year. Americans and the vaccination of young and healthy people could already begin in April.

Polls show that four in ten Americans do not plan to get vaccinated against the coronavirus. True, some of them said that they might change their minds if more people were already vaccinated and more information about vaccines was obtained.

When it comes to the safety of these vaccines, there are already several good reasons to doubt it. So here’s what to say to your friend or family member who is still skeptical about coronavirus vaccines.

1. The fact that a vaccine has been approved by the FDA means that experts agree that the benefits of such a vaccine outweigh the risks for many Americans.

The FDA’s decision was based on the recommendation of an independent panel of scientists and experts. These researchers analyzed data from the last stage of clinical trials collected over a period of months. And that’s the standard process for any vaccine, including the flu shots that Americans receive each year.

During a vote on the Pfizer and BioNTech vaccine, 17 of the 22 members of the group agreed that “the benefits of this vaccine outweigh the risks for people over 16 years old.” Four experts voted against and one abstained.

Disagreeing members of the group generally wanted more safety data on the use of the vaccine in people 16 to 17 years old. One member insisted on data from at least another two months, which would include a greater number of studies involving vulnerable groups.

However, none of the team members raised concerns about the safety of the vaccine.

2. Coronavirus vaccines have already been tested on tens of thousands of volunteers, so scientists have a good understanding of how people respond to them.

The volunteers who participated in the trials received the Moderna vaccine since March and the Pfizer vaccine since April. In both cases, these are randomized controlled trials, which means choosing randomly and blindly which study participants will receive the real vaccine and which will receive the placebo.

The volumes of these two clinical trials were equal to or greater than average. Analysis conducted in 2012 revealed that the average volume of phase III clinical trials is approximately … 30,000. people.

More than 43,000 people participated in Pfizer’s late stage trials. volunteers in six countries and sixteen US states.Only eight cases of COVID-19 were reported in the vaccine group compared to 162 in the placebo group. This means that this vaccine is 95% of the cases prevent the disease.

More than 30,000 people participated in Moderna’s trials in thirty US states. The researchers found 90 cases of COVID-19 in the placebo group and five among people who were vaccinated against the coronavirus, meaning the vaccine is 94.5% effective.

By comparison, the most effective measles vaccine ever is 97 percent effective.

3. Moderna and BioNTech announced the development of their vaccines a few days apart, but that doesn’t mean the process was too fast.

Until then, the vaccine most likely to develop was considered a mumps vaccine that took more than four years to develop. Unlike traditional vaccines, vaccines that use RNA (a genetic material that tells cells to make proteins) can only be developed using the genetic code of the virus. And Chinese scientists sequenced the coronavirus genome and released the information in January.

“It just came to our knowledge then. We just have better technology,” said Albert Rizzo, medical director of the American Lung Association. – Why was it difficult to cross the Atlantic for two weeks in the early 19th century? Because people sailed by boat And now it takes a few hours to redistribute the ocean. “

One of BioNTech’s founders, Ugur Sahin, created a “draft” of the company’s vaccine one weekend in mid-January, a company spokesman said. And Moderna developed her vaccine in just two days.

Subsequently, a public-private partnership (Operation Warp Speed) initiated by the US government to develop a coronavirus vaccine accelerated the development of the Moderna vaccine, as the company received $ 483 million from the US government. $ 472 million in financial injections to develop the vaccine and another $ 472 million. The US dollar was used to speed up clinical trials. Finally, the government provided the company with 1.5 billion. A purchase order of 100 million dollars. vaccine dose.

Pfizer, for its part, has invested $ 2 billion in a vaccine development project. Dollars of equity, reports The Wall Street Journal.

Pfizer tested several potential vaccines at the same time to avoid having to go back to baseline each time we failed. In addition, the company shortened the time to develop the vaccine by months because it used disposable bags instead of steel containers.

Like Moderna, Pfizer produced several doses of the vaccine before clinical trials were completed. Additionally, the company decided to produce vials containing various doses of the vaccine and administer the vaccine at extremely low temperatures, thus ensuring its effectiveness, rather than trying to test whether the vaccine will still be effective at higher temperatures.

4. Vaccines developed using mRNA technology are relatively new, but scientists have been working in this field for decades.

It was discovered by mRNA scientists in 1961. Some thirty years later, researchers at the University of Wisconsin and the biotechnology company Vical Incorporated discovered how to make mRNA to direct cells to make specific proteins.

And in 2005, biochemist Katalin Kariko, who now serves as BioNTech’s senior vice president, discovered a way to configure mRNA to bypass the natural defenses of the human body and prevent a dangerous immune response.

The researcher’s work inspired the founding of Moderna, which currently focuses on mRNA-based therapies. Before the pandemic, Moderna had launched clinical trials of eight mRNA vaccines, including a flu vaccine.

In 2017, Kariko, along with several other researchers from BioNTech and the University of Pennsylvania, found that the mRNA vaccine protects mice and monkeys from the Zika virus. Therefore, the researcher was not much surprised when two vaccines based on mRNA technology protect against COVID-19.

5. Long-term side effects are unlikely. While the short-term effects are what scientists often expect and observe, they are usually mild and transient.

Both Moderna and Pfizer researchers followed their volunteers for at least two months after receiving the second dose of the vaccine (in both cases, two doses of the vaccine must be administered). And there were no security issues.

“The side effects seen with the vaccine generally occur within hours, sometimes days, or very rarely weeks,” Megan Ranney, director of the Brown University Center for Digital Health, said on Twitter.

In the case of vaccines based on mRNA technology in particular, the human body destroys the molecule very quickly, which means that it does not stay in the body for long.

Most people in the Pfizer vaccine trials reported short-term side effects after vaccination, such as fatigue, headache, and injection site pain.
Overall, there were more side effects in people under 55 years old. In the age group 18 to 88 years, 4.6 percent. people said they felt very tired after the second dose of the vaccine, and 3.2 percent. indicated that they had severe headaches.

In Moderna’s trials, some of the 10 participants experienced some side effects, but they were mostly mild to moderate. About 17 percent. participants reported slightly more serious side effects, such as pain or swelling at the injection site, fever, headache, tiredness, nausea, and vomiting.

Side effects were generally felt within one to three days, according to documents published by the FDA.

In both trials, these effects were seen among different genders, different age groups, ethnic and racial groups, and among people with comorbid health problems.

“Past experience has shown that FDA-approved vaccines rarely show serious new and unexpected side effects,” said Noam Tau, a physician at Sheba Medical Center.

6. Researchers agree that vaccination with an FDA-approved vaccine is much safer than COVID-19, which can have known long-term consequences.

Many people with coronavirus experience long-term complications, although researchers don’t yet know exactly how many people have them.

A report published by the US Centers for Disease Control and Prevention in July found that about a third of surveyed coronavirus-infected patients had not recovered after two to three weeks. And findings from a study published in August indicate that one in ten patients had a long-term form of the disease.

Many patients experienced fatigue, muscle pain, shortness of breath, palpitations, or difficulty sleeping for several months. Some have also experienced neurological problems such as dizziness, confusion, or even delusions. Some people have reported strange symptoms like hair loss or a red, scaly rash.

Some COVID-19 patients have reported long-term symptoms such as weakness or “head fog” after excessive physical activity, which is considered the main symptom of chronic fatigue syndrome. This disease can last several years or more.

It’s worth noting that a survey of SARS patients in Hong Kong revealed that 27% met clinical criteria for chronic fatigue syndrome four years after the onset of the disease. (The genetic codes for SARS and the new coronavirus overlap by about 80 percent.)

“There is a growing debate in the medical community about an illness similar to chronic fatigue syndrome that can develop after a coronavirus,” said Nate Favini, PhD. “Unfortunately, the disease can affect a small number of people, and these symptoms really do become chronic and must be treated for years.”