CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness

Please take a look at slide 16 particularly: https://www.fda.gov/media/143557/download

Does not look very optimistic. Will bring it here:

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yes indeed. It is worrying that they are pushing forward so fast to the general population this vaccine.

@Ameli do you know if this any different to what would usually be screened for during late-stage trials or early rollout of any other new vaccine?

What I definitely know from a family member who is a professor of medicine in a German university, among other cross-referencing study I conducted, is that this vaccine goes through an unacceptable unscientific fast-track process. There are no real long-term clinical trials in order to check the list above for this vaccine; given it should take >=7 years (not 7 months) to do so. On top of that, this proposed vaccine has an mRNA biotechnology so it is not like any other ‘‘traditional’’ one and it has never been administered to humans before. Moreover, all other vaccines (e.g. influenza) needed at least 7 years of control tests, before they circulated among public for general use.

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Thank you for sharing the link!

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I’d like to weigh in a little bit on this post. I think a lot of the worries about the current vaccines are (partly) caused by an unfamiliarity with the drug development process in general.

When deciding on an authorisation for a clinical trial or for granting a marketing authorisation, competent authorities (such as FDA) always do a thorough assessment of the risk/benefit for every drug. This is not different for these vaccines.

The side effects list that you posted, seem quite ‘scary’ indeed. Although you would be surprised about the ones listed in the leaflet of a ‘common drug’ as well. I am not sure where this list originated from, but it probably includes all side effects that happened during the current clinical trial or that could theoretically possible. As it says above it is a ‘working list’ that can still change. A lot of these side effects are probably very rare. Additionally, in clinical trials ALL severe adverse events are mentioned. This does explicitely not mean however that these are causually linked to the drug, this is a different assessment. (This is the difference between adverse events and adverse reactions)

Additionally, drugs (so also vaccines) are alwasy being monitored for safety as soon as they enter the market. This ‘trials’ are called phase IV trials. They are conducted because some side effects may be so rare they don’t appear in the phase III trials, that only include several thousand patients. These ‘long-term trials’ you refer to are being performed for these vaccines as for all drugs.

A big reason why the development went faster now, probably is that a lot of companies, competent authorities and also academic partners prioritized the vaccines now.

Of course, all drugs can have side effects and things can always go wrong. But I think the worries about the current vaccines could partly be caused by the increased public attention as well.

EDIT: The statement “this proposed vaccine has … has never been administered to humans before.” is false.

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I think there is no problem in doubting vaccines’ effectiveness and safety and people should not be censored or shamed for this. If they want they can ask for more information about how a vaccine was produced, how it works and what are possible adverse effects (even under consideration).

We all know about thalidomide scandal for which pharmaceutical company Chemie Grünenthal publicly excused only after 50 years (!) and refused to continue to pay reparations to thalidomide’s victims which are still alive and suffering. The problem is that the company was not banned or reformed, no, it is still operating and generating profits from drugs production. The criminal case against Chemie Grünenthal (which despite warnings from doctors and scientists did not stop the production and distribution of thalidomide among pregnant women, and almost pushed it to North America’s market) was closed because there were no legal background on drugs licensure at that time and none knew (!) or could predict (!) the teratogenic effects of new medicines. While COVID-19 vaccines were developed and approved so in a rush, I imagine that in case, there would be huge health issues or long term side effects, pharmaceutical companies would be neither sued nor responsible for this because they did not know (!) it all could happen because the mRNA-lipid technology is quite new for the vaccine production and they were only about to save the world from the coronavirus pandemic (and generate profits, of course).

As for me, I am pro-vaccine, I support vaccination against popular viral diseases (especially in children) but of course, not all vaccines are the same. Anyways, vaccines are a temporary solution, because viruses mutate and vaccine-induced immunity became less important over the time. In addition, human population grows and mixes and it becomes less and less possible to control the vaccine coverage.

After writing my thesis on mumps virus proteins, I am still wondering, why from the first MMR vaccine licensure in 60s (in US) the research on viruses from the same family literally stopped? Why during those 50 years there were so little information about them? As well as about coronaviruses? During last 20 years people were warned about the possible coronavirus outbreaks but so little research was done on them. No therapy was proposed to stop virus, nothing. Viruses will continue to beat human population, especially zoonotic viruses, coming from animal population which humans leave without natural habitat and aggressively exploit. Vaccine is a temporary solution, a temporary remedy, because if nothing would be changed in human behaviour as well as in scientific research priorities, we will continue to have new viruses to come.

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Well said.