fbpx

AstraZeneca partly resumes coronavirus vaccine trial after halting it for safety reasons

Advertisements

This is a follow up to my previous article reporting on the halting of the Astra Zeneca’s Covid-19 vaccine trial following one of the participants suffering a severe adverse seemingly life changing reaction to the vaccine. 

https://unitynewsnetwork.co.uk/serious-adverse-event-in-astrazenecas-covid-19-vaccine-trial-revealed-as-spinal-inflammation-disorder-caused-by-toxic-adjuvants/

Advertisements

AstraZeneca announced that it has resumed its coronavirus vaccine trial in Britain after suspending it for 6 days over potential safety issues but that its trials in the United States and other countries were still on hold.

The Food and Drug Administration (FDA) is reportedly expanding its investigation into the serious illness a patient suffered while participating in AstraZeneca/Oxford University Covid-19 vaccine study.

In furthering its probe into the “unexplained illness,” the FDA will look into earlier trials of similar vaccines that were developed by the same scientists, Reuters reported.

The administration of President Donald Trump has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the United States. Other leading companies in the U.S. vaccine race include Pfizer, Moderna and Johnson & Johnson.

Regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials.

https://www.nytimes.com/2020/09/12/health/astrazeneca-coronavirus-vaccine-trial-resumes.html

Volunteers in Spain quit the Johnson & Johnson COVID-19 trial following the AstraZeneca scare

Without stating the number of people who’ve dropped out of the J&J trial, the study’s lead researcher told Reuters there still were enough “reserve” volunteers for the project to continue.

J&J are in the early stages of the trials but were hoping to move the vaccine into Phase III of the trial by the end of 2020 or early 2021.

https://www.reuters.com/article/us-health-coronavirus-vaccine-spain/some-volunteers-quit-jj-covid-19-trial-in-spain-after-astrazeneca-scare-investigator-says-idUSKBN2662HI

https://unitynewsnetwork.co.uk/johnson-johnson-hit-with-750m-verdict-in-baby-powder-lawsuit/

AstraZeneca, Pfizer and Moderna are the 3 companies currently in Phase III late-stage clinical trials in the United States.

Pfizer states late-stage coronavirus vaccine study shows moderate side effects  

The news that AstraZeneca were resuming their trial came on the same day that competitor, Pfizer, said it was expanding the trial of its coronavirus vaccine from 30,000 to 44,000 people in an effort to recruit a more diverse group of participants and potentially cut down the time needed to get results from the trial. Pfizer is working in partnership with German partner BioNTech.

Pfizer stated participants were showing mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.

Over 12,000 study participants have received a second dose of the vaccine. https://www.reuters.com/article/health-coronavirus-pfizer-idUSKBN2670AO

Moderna Therapeutics – 4 people have had a systemic adverse reaction to the vaccine.  

In the 45-person Moderna study, 4 participants experienced what are known as “Grade 3” adverse events — side effects that are severe or medically significant but not immediately life-threatening. 

Patients in clinical trials are usually faceless but trial volunteer Ian Haydon, a 29-year-old from Seattle decided to speak out about his experience on CNN and CNBC.

He experienced a severe reaction to Moderna’s Covid-19 vaccine but states he is still a believer.

12 hours after receiving his 2nd dose, he developed a fever of more than 103 degrees. 

The clinic where he was vaccinated had given him a 24-hour phone number to call, but he’d been reticent. His girlfriend, with whom he lives, called. They said to go to urgent care. It was a 10-minute drive. They arrived at 5 a.m.

The doctors met him in what looked like space suits.  Even though he’d had a vaccine, he was also a potential Covid patient.  They took him into an exam room, took a lot of blood, and gave him a nasal swab. He asked them to avoid his left arm, where he’d gotten the vaccine, but they ended up taking blood from both of his arms. His fever had already fallen to 99.8 degrees. They gave him Tylenol. The physician taking care of him offered to try to get him admitted to a neighbouring hospital, but he decided to head home.

He and his girlfriend arrived home at 7 a.m., and he slept until noon. His temperature was 101.5. He got up to go to the bathroom, and became so nauseous he threw up. On his way back from the bathroom, he fainted. His girlfriend caught him and kept his head from hitting the floor. 

She then called one of the doctors working in the study, and asked what they should do. The doctor told them he could go back to urgent care, or call 911, and reminded them that all his medical costs would be covered by the study.

But he got to a couch and was given a sports drinks. He spent the afternoon there, with a wet towel on his head, fighting the fever. By 9:45 p.m., it was back down to 99.1. It tapered off.  He says he felt better within a few days, and has had no side effects since.

He stated I understand that sharing my story is going to be frightening to some people and I hope it doesn’t fuel any sort of general antagonism towards vaccines in general or even towards this vaccine.

He decided to speak out because he hoped his story would counterbalance the desperation that some people feel to push a vaccine to market regardless of the consequences.

William Schaffner, a Professor of Preventive Medicine and Infectious Diseases at Vanderbilt University Medical Centre stated “such side effects are noteworthy, but it doesn’t stop the train.  The goal of studies is to establish a threshold at which something might go wrong”. https://www.statnews.com/2020/05/26/moderna-vaccine-candidate-trial-participant-severe-reaction/

Analysis

Researchers have yet to produce a safe and effective vaccine against any coronavirus. 

When researchers were experimenting on vaccines against SARS (similar to COVID-19), trials were halted completely, after the vaccinated animals developed more severe (sometimes fatal) versions of SARS than the unvaccinated animals due to Antibody-Dependent Enhancement (ADE) – (interestingly the animal testing stage has been removed from SARS-Cov-2 trials).  

ADE of infection can be a significant obstacle to the development of safe effective vaccines. The mechanisms of ADE still remain to be better understood.  

I guess the million dollar question has to be would you take an experimental vaccine shrouded in ambiguity about long term health risks or take your chances with Covid-19 which we now know has a survival rate of well over 99% and from which most of us will suffer little or no symptoms at all.

I know my answer, how about you?

https://pubmed.ncbi.nlm.nih.gov/12725690/

https://unitynewsnetwork.co.uk/military-study-finds-flu-vaccine-increases-coronavirus-risk-by-36/

 

Leave a Reply

-->
>