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Five things you need to know about: mRNA vaccine safety
[HorizonMagazine] 1. mRNA vaccine technology is not entirely new
Vaccines such as the inactivated polio vaccine, or most flu vaccines, use inactivated viruses to trigger a person’s immune system to respond to that disease-causing organism.

...mRNA vaccines, however, trick the body into making the viral protein itself which, in turn, triggers an immune response.

Although the COVID-19 vaccines made by Pfizer/BioNTech are the first mRNA vaccines to complete all clinical trial stages and be licensed for use, the technology has been around for a while.

Human trials of cancer vaccines using the same mRNA technology have been taking place since at least 2011. ’If there was a real problem with the technology, we’d have seen it before now for sure,’ said Prof. Goldman.

Because the technology can be deployed extremely rapidly, and clinical trials have been so successful, mRNA platforms will be an important means of preparing for future epidemics, he says.

2. mRNA vaccines do not alter your DNA
A concern that some have had about the mRNA vaccines is that they could change people’s DNA. But that idea is ’completely false’ and has ’no scientific basis’, says Prof. Goldman.

’The (vaccine) mRNA will not enter the nucleus of the cells, where our DNA is.’

Once the injected mRNA enters a human cell, it degrades quickly and only stays in the body for a couple of days. This is why people need two injections to develop the best immune response, he says.
And even if they do - so what? According to some authors, half the junk DNA in our bodies is of viral origin.
3. mRNA vaccines are very specific ...

4. Corners were not cut in the clinical trials and approvals process
Vaccine trials take place in stages, starting with trials on animals, and then three trials on people — Phase 1, Phase 2 and finally Phase 3.

The Pfizer/BioNTech vaccine Phase 3 trial involved more than 40,000 people. It began in July and will continue to collect efficacy and safety data for another two years.

Safety issues that would affect significant numbers of vaccines mostly appear within two months, Prof. Goldman says.

However, after a vaccine is given to millions of people, very rare side effects that cannot be anticipated from clinical trials might develop, so researchers and regulators will be keeping a close eye on how the vaccine rollout goes. This will be especially important for Covid-19 vaccines based on innovative technology.

Regulatory agencies reviewed the data from Covid-19 vaccine trials more quickly than usual by looking at it on a rolling basis rather than only once the trials were complete, but they did not fundamentally change their rules. ’I really don’t think that corners were cut in terms of safety,’ said Prof. Goldman.

5. The vaccine triggers an inflammatory response
The vaccine partly works by inducing local inflammatory reactions to trigger the immune system. This means that it’s normal for many people to experience pain at the site of the injection and sometimes fever and discomfort for one or two days after the vaccine.

’This is something that has not been advertised enough,’ says Prof. Goldman.

A November survey in 15 countries found 54% of people were worried about possible side effects from a Covid-19 vaccine.

One unwanted response to the Pfizer-BioNTech mRNA vaccine came to light during the first day of mass vaccination in the UK after two people with a history of significant allergies reacted to the injection. The UK regulatory authority updated its advice to specify that people with a history of anaphylaxis to medicine or food should not get the shot.

In the clinical trials, allergic reactions occurred in 0.63% of people given the Pfizer-BioNTech vaccine, and in 0.5% of people given a placebo.

Posted by: g(r)omgoru 2021-02-02
http://www.rantburg.com/poparticle.php?ID=593215