Monday, December 21, 2020

Are these rushed vaccines safe?

These Covid-19 Vaccines were “rushed”. Can they still be safe?

John Kitsteiner, MD, Emergency Medicine Physician
East Tennessee 

Novel (new) vaccines typically take years to develop.
These COVID-19 vaccines have been produced in record time, but that doesn’t mean they were “rushed”.

The process was mainly sped up by three things:

1) Streamlining the process.
The whole process was significantly faster due to streamlining the paperwork aspects of vaccine production. Paperwork filing and review is usually done in batches, sometimes only being submitted every few weeks or months.  With such a great need, the hospitals and academic labs filed paperwork daily. The scientists who review the paperwork did it immediately when it was received; they didn’t place the paperwork at the bottom of the pile and work their way to it… vaccine paperwork cut to the front of the line every time. Additionally, these review scientists often worked seven days a week to expedite the process.

2) Making information public.
Research labs and scientists typically keep their research private. They don’t want to share their findings until they are done with a project so they can be the first to publish an article, develop a medicine, etc. But due to the importance of developing a vaccine, scientists from around the world made their research public immediately. There was an unprecedented sharing of information. This included the SARS-CoV-2 virus genome (the genetic code of the virus that causes the COVID-19 infection). Usually, each lab has to perform each step on their own, but by sharing information, each lab could take that information and move on to the next step. That is a HUGE savings of time.

3) Lots of funding (money)!
Vaccines do not make a lot of money for the pharmaceutical companies, and whether you like it or not, the potential to make money is what directs a lot of research. Vaccines are typically used only a few times in a person’s life (compared to that medicine you need to take twice a day for 30 years), so vaccines don’t bring in a lot of cash flow. And because they take time to develop (see above), vaccines are often not a high priority for pharmaceutical companies. But because of the worldwide impact the virus has had on the lives and economies around the world, a lot of money from governments and the private sector was given to develop the vaccines.

Researchers suddenly had the funding for extra help and machines and space. They had (almost) a blank check to make things happen, they had readily access to shared information, AND they had a fast-pass to the front of the bureaucratic line each step of the way. None of the testing or safety aspects were reduced or skipped.

Physicians and nurses are getting the vaccine first. We are the first guinea pigs, so to speak, of the general public not in a trial to get this vaccine. This is anecdotal, but I do not know a single physician who is not getting the vaccine as soon as it is available, unless they have a contraindication (medical reason for not doing it). In fact, most are publicly posting photos of themselves getting it. And this is happening all over the world, not just in the US.

Yes, this vaccine was produced in record time. But that doesn’t make it unsafe, not by any means.

If you want to see the data on the two COVID vaccines for the US, you can see it here:
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
https://www.fda.gov/media/144434/download

(the photo is of my friend and colleague getting her vaccine!)

1 comment:

Anonymous said...

The very other important thing to note that contributed to the speed of the vaccine is that it isn't as though this vaccine was created out of thin air over the past few months. The science behind it has actually been in development for around 17 years in response to other coronaviruses (SARS and then later MERS).

Apart from coronaviruses specifically, nucleic acid vaccines have been researched for around 2 decades and RNA vaccines in particular have come along way in the past decade or so. The Astra Zeneca vaccine, which doesn't use mRNA, was similarly made possible so quickly due to pre-existing research on viral vectors.