How can the vaccines be safe and effective if they were developed so quickly?

M essenger RNA technology had been studied, developed and refined for years before it was used in the coronavirus vaccines. To develop the two mRNA vaccines, all scientists essentially needed to do was plug in the molecular code for the coronavirus’s spike protein , said Robert Murphy, executive director of the Institute for Global Health and a professor of medicine and biomedical engineering at Northwestern University. (The vaccines contain molecular instructions — mRNA — that tell your cells to create a harmless protein similar to the spike protein on the surface of the coronavirus. Your immune system will recognize this harmless protein as an interloper, and be primed to eliminate the actual coronavirus if you are exposed to it.) That, along with the urgent need, billions of dollars in funding and a streamlined regulatory pathway, allowed enterprises such as the Pfizer-BioNTech partnership and Moderna to roll out the vaccines in record time. Though the process happened quickly, experts said no corners were cut in bringing the vaccines to market. The mRNA vaccines as well as Johnson & Johnson’s single-shot regimen, which uses the more traditional approach of a harmless cold virus, were studied in tens of thousands of p eople in U.S. clinical trials before receiving emergency use authorization from the Food and Drug Administration. “Even before these vaccines were authorized, we had the same quality and volume of research evidence that we would have for any vaccine,” said Jason L. Schwartz, an assistant professor of health policy at the Yale School of Public Health. One difference that helped speed things along is that the Phase 1, 2 and 3 trials were done in rapid succession, experts said, while there might be months between phases for less-urgent vaccines. Emergency use authorization also helped streamline the approval process by requiring a shorter observation period during the trials than mandated for full approval. But the trials weren’t stopped after authorizations were issued; they are continuing with monitoring of the original participants, just as they would for other vaccines in non-pandemic times. Furthermore, experts emphasized, safety and effectiveness have always been a priority for manufacturers and the federal regulators: Tan noted that the FDA convened multiple meetings with an independent panel of experts to evaluate the vaccines, even though this wasn’t required for emergency authorization. With more than 150 million people at least partially vaccinated in the United States as well as strong and continuing safety surveillance, Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, said study of the coronavirus vaccines “has actually been much more extreme than any amount of scrutiny that has gone into any vaccine in the past.”

Are the vaccines “experimental?”

No. An experimental vaccine is one that has not gone through clinical trials and authorization or approval processes. The available coronavirus vaccines have completed clinical trials and have been authorized for emergency use. Pfizer recently filed for full approval from the FDA. While scientists are conducting research and collecting data on people post-vaccination, that isn’t unusual for medical products, including vaccines, which often continue to be studied well after they’ve been introduced to the public, Schwartz said. “We have now an enormous trove of data that has come from literally the hundreds of millions of vaccines that have been administered in the United States and around the world that have been extensively studied and monitored in real-world use to confirm safety and confirm effectiveness,” he said.

Will the vaccines cause infertility?

The contention that the coronavirus vaccines might cause infertility is an argument that has been raised about other vaccines in the past but is “a complete myth” with no basis in science, said Sean O’Leary, vice chair of the Committee on Infectious Diseases for the American Academy of Pediatrics. “There’s no reason to think that these vaccines are going to affect fertility any more than any other vaccine — and no vaccine in history has ever had any impact on fertility,” O’Leary said. The false claim specific to the coronavirus vaccines contends that mRNA vaccines could cause infertility by priming the immune system to mistakenly attack a protein in the placenta that is believed to be similar in some ways to the coronavirus spike protein. But researchers have compared the two proteins and found the similarities to be too insignificant to be a concern, The Washington Post’s Ariana Eunjung Cha reported . The scientists also studied how reactive various proteins in humans are to the antibodies formed by natural infection with the coronavirus or vaccination. No reactivity was observed for the protein in the placenta.

Will the mRNA vaccines change my DNA?

No, that’s not possible, experts said. The messenger RNA in the Pfizer and Moderna vaccines that helps create the immune response against the coronavirus doesn’t enter the nucleus of the cells where DNA resides. “There literally is no physical connection between the RNA in these vaccines and the DNA in our cellular nuclei,” Schwartz said. “So there’s no possibility for that connection, let alone for effects or adaptations.”

Will the vaccines alter my immune system?

Every vaccine is intended to rev up the immune system to generate antibodies against a target virus. But there is no evidence to support claims by anti-vaccination activists that the coronavirus vaccines, particularly the mRNA shots, can permanently alter the immune system or lead to autoimmune diseases. In fact, federal health authorities have said that the vaccines are safe for people who are immunocompromised . Murphy said that in exceedingly rare circumstances, some of the vaccines have triggered adverse reactions thought to be related to an immune response. One participant in the AstraZeneca clinical trial in Britain developed symptoms consistent with transverse myelitis , a rare neurological disorder characterized by inflammation of the spinal cord, but the diagnosis was not confirmed. And rare blood clots have been observed in people who received the Johnson & Johnson vaccine and Oxford-AstraZeneca vaccine . Murphy said that although any vaccine poses exceedingly rare risks, the complications of covid-19 are much more common and can be fatal, even for young people with healthy immune systems. A study of more than 3,000 patients younger than 35 who developed severe covid-19 found that out of those who were hospitalized, 21 percent required intensive care, 10 percent had to be placed on ventilators and nearly 3 percent died. “You can be the healthiest person on earth and you can die from covid,” Murphy said.

Do the vaccines contain aborted fetal cells?

There are no aborted fetal cells or tissue in any of the coronavirus vaccines. The confusion, experts said, arises largely from the well-established practice of developing and testing medical products, including vaccines, using historical fetal cell lines that were derived decades ago from elective abortions. These cell lines have been used to create vaccines against diseases such as hepatitis A, rubella and rabies. Public health experts said these cell lines were used in the development of both of the mRNA coronavirus vaccines to understand how they worked. They were also used in manufacturing the Johnson & Johnson vaccine, said Barouch, whose lab collaborated with Johnson & Johnson in the development of the vaccine. He and other experts have pointed out that although the Catholic Church is opposed to abortion, the Vatican has issued a statement stating that, in situations when there is no vaccine available that has been developed without fetal cell research, taking one of the authorized vaccines would be morally acceptable. “All the covid vaccines recognized as clinically safe and effective can be used in good conscience,” Bishop Kevin C. Rhoades, chairman of the U.S. Conference of Catholic Bishops’ Committee on Doctrine, said in a recent YouTube video .

Do the vaccines contain microchips?

It appears this myth may have at least partly originated from a comment from Bill Gates that was misconstrued and shared widely across social media. But “it couldn’t be further from the truth,” Murphy said. Gates was asked on Reddit about future business practices in the covid-19 era and mentioned the possibility of eventually having a “digital certificate” to show who has recovered from the virus or been inoculated against it. The business magnate did not, however, suggest this digital health record he was thinking about would come in the form of a microchip injected into individuals’ arms during vaccination. Also, injecting microchips would be physically impossible as they wouldn’t fit through a needle. So rest assured: “We know for certain there are no microchips in any vaccine,” Murphy said.

Wellness

Are they experimental? Can they alter DNA? Experts tackle lingering coronavirus vaccine fears.

By Allyson Chiu

and

Lindsey Bever

May 14, 2021 at 8:00 a.m. EDT

When the coronavirus vaccines first started rolling out in December, LisaRose Blanchette had doubts. To her, it felt like the shots, particularly the messenger RNA vaccines, had been “rushed through production,” and she didn’t trust that they would be safe or effective.

“At the time, I was feeling very insecure about them,” said Blanchette, 56, a teacher in Phoenix. But she started doing her own research and soon realized her initial concerns had been misconceptions.

“I needed to understand the mRNA vaccine. I needed to understand how long scientists had been working on it. I needed to understand that it was divorced from the politics that I had been reading about,” she said. She got vaccinated as soon as she was eligible.

But millions of Americans are still hesitant or altogether unwilling to receive any of the three coronavirus vaccines authorized in the United States. While 11 percent of people who remain unvaccinated say they will definitely get a shot, 34 percent say they definitely will not, according to a recent poll conducted by the Associated Press-NORC Center for Public Affairs Research. This reluctance, experts say, is partly fueled by rampant misinformation promoted by anti-vaccination organizations and individuals, which has undermined trust in science and generated skepticism about the authorized vaccines.

“Even the people who are fence-sitters or are fairly reasonable people are going to say, ’Wait, how come there’s so much controversy?’” said L.J Tan, chief strategy officer with the Immunization Action Coalition. “The problem about that is that the controversy is entirely created by the misinformation.”

Here are some of the questions that remain because of misconceptions and what experts have to say about them.

Are you still deciding whether you'll get a covid-19 vaccine? Share your experience with The Post.