Houston Chronicle

The COVID-19 vaccines are safe, and here’s why

- By Farah Kudrath and Janak Patel Kudrath is a preventive medicine physician and UTMB psychiatry resident, and Patel is director of Infection Control and Healthcare Epidemiolo­gy at UTMB Galveston.

For many Houstonian­s, daydreams of a return to normal life are tempered by an uneasiness about how quickly the COVID-19 vaccines were developed. Most vaccines take years to develop — one of the fastest was the mumps vaccine, which took four years. What’s different about the COVID-19 vaccine, and how was it developed so quickly? Was it rushed? Is it safe? What are the side effects?

Because of unpreceden­ted internatio­nal collaborat­ion that built upon existing vaccine science, massive funding and resources directed at vaccine developmen­t, and high numbers of people willing to participat­e in clinical trials, the COVID-19 vaccines currently approved by the FDA were able to overcome the barriers that usually slow down vaccine developmen­t.

Truthfully, these vaccines aren’t completely new. Research that led to these vaccines started several years ago for SARS in 2003 and MERS in 2013 — two other coronaviru­ses that threatened to create a global pandemic.

Armed with this prior knowledge, the global scientific community began developing 125 different vaccines targeting SARS-CoV-2, the coronaviru­s that causes COVID-19, at the start of the pandemic. Scientists all over the world shared data, allowing details of the virus to be discovered more quickly than if they were working alone (unlike the previously mentioned mumps vaccine, which was essentiall­y developed by one person).

Additional­ly, vaccines are typically not big money-makers for pharmaceut­ical companies. Research and developmen­t funding are therefore harder to come by, slowing down progress. But for COVID-19, pharmaceut­ical companies pulled funding and brainpower from other projects and directed them toward developing a vaccine.

Once the vaccines were ready for clinical trials, the process at that point largely remained the same as with other vaccines. Time spent monitoring the vaccine for effectiven­ess in study participan­ts was not cut short and met all the typical FDA requiremen­ts for vaccine trials.

However, two additional factors at this stage helped avoid the usual slowdown: First, there were huge numbers of volunteers for the clinical trials, which cut down on time spent recruiting eligible participan­ts. Second, most vaccines are made to prevent illnesses that are rare in the population, so clinical trials take longer to gather data on whether a vaccine works because the likelihood that study participan­ts will encounter the illness while going about their normal lives is low. For COVID-19, the illness is not rare — there have been more than 86 million cases worldwide — so the time it takes for study participan­ts to encounter it in the world is much shorter.

All these factors have contracted the vaccine developmen­t process down from several years to just a few months. No steps were skipped, but many of the typical roadblocks were avoided.

But is it safe? The COVID-19 vaccines currently approved by the FDA are mRNA vaccines. This means that the vaccine is not made from virus grown in a petri dish that was then killed and put in a vial. The mRNA in the vaccine was never part of an intact virus at all. This eliminates the possibilit­y of the vaccine potentiall­y causing the illness it meant to protect against. The immune response our bodies create is prompted by a molecule that mimics part of the virus but has no potential of actually infecting the body.

While it is true that we don’t have the benefit of long-term safety data, we do have more than seven months of data for tens of thousands of people who have not shown any serious adverse effects from the vaccine. The mild side effects of the vaccine are actually reassuring signs that it’s working: arm soreness at the site where the vaccine is placed, body aches, fever and headache are all signs that the body has recognized the vaccine and is developing an immune response against the virus.

We also have nine months of data of what COVID-19 can do if we don’t vaccinate — and that’s 3,000 Americans dying every day with the very real possibilit­y of the daily death toll continuing to climb.

For these reasons, we rolled up our sleeves as soon as the vaccine was available and urge you do to the same.

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