India's Vaccine Center Rejects Volunteer's Claims of Dangerous Side Effects

AP Photo/Hans Pennink

A volunteer in India’s Oxford vaccine trials claims the serum has dangerous side effects after being administered a dose and losing a project and finding it difficult to perform simple tasks.

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The wife of the volunteer claims no financial motive but said they were asking for 50 million rupee (about $600,000) from the manufacturer as compensation.

The vaccine center in charge of administering the tests took the claim very seriously and the trial was delayed while an investigation was undertaken. Eventually, they found no merit to the complaint and authorized the trials to proceed.

With the world already skeptical that any vaccine is safe, this certainly doesn’t help.

NDTV:

The Adar Poonawalla-led Serum Institute of India (SII) also said the vaccine was “safe and immunogenic” and the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared” the trials after examining the complaint.

”After initial causality assessment, findings did not necessitate stoppage of the Serum trials. SII vaccine trials have entered Phase 3. After reviewing all documents, SII has been given permission to conduct Phase 3 trials. Bharat Biotech also has been allowed to conduct Phase 3 trials,” said Rajesh Bhushan, Health Secretary.

The 40-year-old marketing professional who claims to have been injured by the vaccine is described as “well informed” and “creative.”

“Even after two weeks, simple things like online payments… he asks me to do. He got a good project during the pandemic; it was an American project that started on October 1. Apparently, he has lost that. Because of his condition the clients have moved back. They wanted their work to be done quickly.”

The couple said it was hugely worrying that the trials continued even after their complaint.

“Our question was, why didn’t they halt the trial when such an adverse reaction was seen? At least until they were 100 per cent sure? How could they administer vaccine again to volunteers before informing them,” she said.

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The vaccines ready to be released in the U.S. show “significant” side effects in 10-15 percent of patients. That’s a higher percentage than most vaccines, but in the overwhelming number of noticeable side effects, the symptoms are mild.

CNBC:

The side effects, which come from the vaccine shots, can last up to a day and a half, said Dr. Moncef Slaoui, who is leading the Trump administration’s Covid-19 vaccine program Operation Warp Speed. The people who’ve suffered from side effects have reported redness and pain at the injection site as well as fever, chills, muscle aches and headaches, he said, adding most people have no noticeable side effects.

Still, the long-term effects of the vaccine are unknown.

“The longer, more important kind of adverse events such as some autoimmune disease or others have not been reported in a different way between the placebo group and the vaccine group in these two trials, which is very reassuring,” he told The Washington Post. “I always make sure we say that [while] we know the short term and I’m going to call it midterm effects of the vaccine is now well understood, the very long-term safety is not yet understood by definition.”

Judging by how past vaccines have performed, you wouldn’t expect any severe long-term consequences from a COVID vaccine. It’s not impossible to imagine some sort of serious long-term reaction, but it’s very unlikely.

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That said, there’s risk in anything we put in our bodies. Of course, it helps to know all the risks so we can make intelligent choices, but in this case, the risks of being administered a vaccine must be weighed against the risk of getting seriously ill from the coronavirus. That’s a decision each of us as individuals must make.

All attempts at forcible vaccinations or requiring vaccination for employment must be resisted. No matter what the CDC or FDA says about the serum’s safety, this is still an experimental vaccine. Forcing anyone to get vaccinated would be a violation of our right to privacy and should be prevented.

 

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