The COVID-19 vaccine can cause side effects.This is why you shouldn’t stop getting shots

A friend of Paul Offit volunteered for one of the COVID-19 vaccine trials, but like everyone who participated, he was not informed whether he was injected with a placebo or the real thing.

The morning after taking the second dose, a North Carolina man woke up with a headache and general malaise and immediately called Ofit. He was overjoyed.

“He said,’Yes, I got the vaccine!'” Recalled Ofit, a prominent infectious disease specialist at the Philadelphia Children’s Hospital.

Men’s unpleasant symptoms are a sign that the vaccine is working, Offit said Wednesday in a webcast run by the Journal of the American Medical Association (JAMA). When his friend receives an injection, cells of his immune system react by sending an inflammatory warning signal, which the antibody and others remain in his system the next time he encounters the actual virus. Caused the formation of a customized defense of.

However, like other vaccines, these inflammatory chemicals can also cause side effects. And there are public health messaging challenges in the coming months.

Some people will experience side effects and will conclude that the vaccine gave them COVID-19 — this is wrong. The three vaccines with known results (Pfizer, Moderna, and AstraZeneca) are biologically impossible for the reasons described below.

Others may be worried that the process is in a hurry, or two of them are made up of genetic molecules called messenger RNA-the first one approved for general use. Vaccines like. These are fair questions. However, according to infectious disease experts, record speed in the development of this drug has been made possible by the huge investment of the government and the technological advances that have been undertaken over the years.

Yes, some people develop side effects. Most are mild or moderate and disappear within a day or two. There are no signs of long-term complications. Given the alternative (the risk of a “kneeling” virus infection, as Ofit said), doctors say the vaccine is worth a bit of ancillary discomfort.

This is what you expect.

Complete safety data have not yet been disclosed, but preliminary results are promising.

The vaccine produced by Moderna, based in Cambridge, Massachusetts, did not identify any significant safety concerns in the first 15,000 people who received the injection. Most of the reported adverse reactions occurred after the second dose: malaise (9.7% of recipients), myalgia (8.9%), arthralgia (5.2%), headache (4.1%), injection site Redness (2%). Less than 2 percent report high fever.

Of those who received the Pfizer vaccine in collaboration with the German company BioNTech SE, 3.8% reported malaise and 2% suffered from headaches. Details will be announced on Tuesday, two days before the data are reviewed by the US Food and Drug Administration Advisory Board (Offit is a member).

Seth Wells, a professor of epidemiology at Drexel University’s Dornife School of Public Health, said some volunteers are likely to have experienced multiple of these side effects. In other words, all these percentages should not be summed to determine the potential for side effects. There are some overlaps.

Still, let’s say that a total of 15% of recipients feel pretty terrible a day or two after the second dose. It will be millions of people. Employers with essential workers should be careful not to vaccinate all at once in case some need to stay home for the day.

However, Neil O. Fishman, an infectious disease specialist and chief medical officer at the University Hospital of Pennsylvania, said holiday work was worth the trade-off. Preliminary study results suggest that the Moderna and Pfizer vaccines prevent 95% of COVID-19 cases.

“We’ve seen what a vaccine-free world looks like,” Fishman said. “I’ve seen death, I’ve seen economic sacrifices. I’ve seen the impact on doctors, nurses, their families, and the education system and children. Looking at the data we have, it is very clear to me that the benefits of these vaccines far outweigh the risks. “

The side effects of the vaccine tend to appear after a few weeks at the most, within a day or two. Wells, an epidemiologist at Drexel, said that if tens of thousands of volunteers had a really serious impact in various clinical trials, it would have been detected so far.

He said that if more people were vaccinated, for example at 1 in 200,000 or 1 in 1 million, some rare side effects could occur. But even in peacetime, vaccine testing is being conducted with far less than 100,000 volunteers, similar to what was done this year.

And if you get sick after vaccination, it’s not evidence that the injection was the cause, Wells said. Establishing causes and consequences is a math problem — do obvious side effects occur more often than unvaccinated people? — And biological validity.

An example of a textbook is Guillain-Barré Syndrome, a neuropathy that occurred in hundreds of people vaccinated against swine flu in 1976 and 1977. This is a vaccine developed in response to the outbreak of swine flu in Fort Dix, New Jersey.

Guillain-Barré syndrome occurs when the immune system attacks the “peripheral” nervous system (nerve cells outside the brain and spinal cord), causing weakness and paralysis.

Epidemiologists have determined that for every 100,000 vaccinated people, one case of Guillain-Barré syndrome occurred above the normal rate of this rare condition. And the link between cause (increased immune response) and outcome was medically plausible.

However, most medical conditions have nothing to do with vaccines. Robert Wachter, director of medicine at the University of California, San Francisco, is worried that people may blame the COVID-19 vaccine for completely unrelated illnesses such as cancer, heart attacks, and strokes. In a long Twitter thread, he warned:

“The vaccine has nothing to do with any of them.”

Vaccine testing generally lasts for years. Scientists also pay attention to side effects, mainly to see how well the recipient is and how long he is protected from the disease.

Participants in the COVID-19 vaccine trial will also be followed for years. So how can scientists already say that the injection worked?

Call it a pandemic silver lining.

Statisticians can determine if a vaccinated person is less likely to get the disease than a placebo, as it usually takes months for a sufficient number of illnesses to occur. However, due to the surge in the number of COVID-19 cases this fall, the response was much faster.

For example, in the case of Moderna, 95 of the 30,000 study participants were identified in mid-November. In 90 cases, the person got a placebo — dramatic enough for researchers to conclude that the vaccine prevented most cases of illness.

The extraordinary rate at which these vaccines were developed has been made possible for other reasons as well. Pharmaceutical companies typically wait months, or even years, between various regulatory hurdles before deciding to invest in the production of vaccines.

However, multiple government investments, such as the Trump administration’s Operation Warp Speed, have removed much of the business risk from the equation. Pharmaceutical companies began preparing a few months ago to make a vaccine in case they worked.

Finally, technology has speeded up the process. The first two companies to report the results, Pfizer and Moderna, used a molecule called messenger RNA to make the vaccine. They contain genetic instructions for human cells to make “spike” proteins. This is a small protrusion that forms the corona from which the name was derived around each coronavirus particle.

Traditional vaccines are made up of a whole weakened or inactivated virus that encourages the immune system to provide other defenses called antibodies and T cells. However, Pfizer and Moderna results show that spike proteins alone are sufficient to drive this protective response.

And by itself, proteins cannot cause infections. Fishman, Penn’s doctor, said it was “impossible” for these vaccines to cause COVID-19.

Vaccines produced by AstraZeneca, the third company to report results, provide spike instructions in another way: they are carried by another virus called adenovirus. These viruses also cannot cause illness in humans, and COVID-19 itself is much less common.

If approved, Pfizer and Moderna products will be the first RNA vaccines given to the general public. However, the underlying science behind it has been going on for years, including a major hurdle cleared in 2005 by immunologist Drew Weissman, a colleague at the University of Pennsylvania in Fishman, and Catalin Calico, now at BioNTech. I am.

Molecules are well tolerated by the human body. And in any case, they don’t stick. When used in the production of proteins, RNA is rapidly degraded. And it can’t be part of your DNA.

Fishman is confident that this approach is solid.

“For me, the most important measure of a vaccine is whether to give it to my family,” he said. “I will give this vaccine to my wife and children, and to me as soon as it becomes available.”