Newly released FDA (U.S. Food and Drug Administration) document has revealed deaths of 6 participants during Pfizer’s COVID vaccine trials. According to one Pfizer trial participant, after the second shot, he woke up with chills, shaking so hard he cracked a tooth. “It hurt to even just lay in my bed sheet,” he said.
The FDA announced on Tuesday that two trial participants have died after receiving their coronavirus vaccine. According to Maariv, the sister publication of The Jerusalem Post, the FDA announced on Tuesday that there currently is not enough research to guarantee the vaccine’s safety for immunocompromised groups, pregnant women and children.
According to the published data, six of the participants in the experiment died, two of whom received the vaccine and four of the control group were given placebo.
The Jerusalem Post meanwhile changed the headline of their story from FDA announces deaths of two Pfizer vaccine trial participants (archive link) to First Pfizer coronavirus vaccines expected to land on Wednesday (live link).
The 53-page briefing report (read full report below), released on Wednesday morning is the first detailed analysis of the vaccine trial by Pfizer and BioNTech, which found in November that its vaccine was 95 per cent effective in preventing coronavirus infections.
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According to the published FDA report:
A higher proportion of vaccine recipients reported adverse events compared with placebo recipients, and this imbalance was driven by reactogenicity (solicited adverse events) reported in the 7 days following vaccination and unsolicited adverse events corresponding to reactogenicity symptoms among participants not in the reactogenicity subset.
The frequency and severity of systemic AEs were higher in the younger than the older age groups. Within each age group, the frequency and severity of systemic AEs was higher after Dose 2 than Dose 1, except for vomiting and diarrhea, which was generally similar regardless of dose. For both age groups, fatigue, headache and new/worsened muscle pain were most common.
One Pfizer trial participant told CNBC that after the second shot, he woke up with chills, shaking so hard he cracked a tooth. “It hurt to even just lay in my bed sheet,” he said.
Others experienced headaches and fatigue.
When trial participant Yasir Batalvi first read Moderna’s 22-page consent form warning of side effects ranging from nothing at all to death, he felt pretty worried, he told CNBC.
Due to number of reports of severe adverse reactions Moderna has already stopped testing the highest dose of its vaccine during the trial.
Meanwhile, another volunteer died during trial of COVID-19 vaccine developed by AstraZeneca and Oxford University. Earlier, drug giant AstraZeneca had stopped global trials of its coronavirus vaccine after it caused a mysterious illness in one of the volunteers. The company said it is investigating the cause of the unexplained illness but did not say who had stopped the trial. The mysterious illness is reported to be an inflammatory syndrome known as transverse myelitis which may lead to paralysis.
There is a lot of unrest and distrust among people with regards to the COVID-19 vaccine and regulators and companies alike have been working to ensure people trust in the vaccine authorization process.
However, as reported by GreatGameIndia earlier, a senior managerial executive of AstraZeneca has revealed in shocking details that the company could not be on the receiving end of any constitutional motion or face legal action for any possible side effects or unwanted reactions induced by its Covid-19 vaccine.
The company has agreements with governments as per which AstraZeneca cannot be held responsible for any side-effects of the vaccine and those affected will have no legal recourse.
AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine by most of the countries with which it has struck supply agreements.
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