AstraZenica Vaxx May Damage, Kill. Never Mind: Approval Moves Swiftly Forward

Operation Warp Speed: The Syringe of [Liability Free] Death?

Opinion by Dr Rima
Rima E. Laibow, MD, Medical Director, Natural Solutions Foundation, December 2, 2020

The UK has today approved Pfizer’s dangerous, poorly tested COVID-19 vaccine for “emergency use”. The other neck-and-neck  vaccine candidates are all racing for the brass ring of billions of doses over and over again for all of humanity.  The potential health results are, quite literally, anyone’s guess, but the race goes no. Fiercely.

AstraZenica’s COVID vaccine faced new controversy this week after a trial participant in India alleged that the vaccine caused him serious “neurological and psychological” symptoms.[1]

The accusation was the latest in a series of complaints or concerns surrounding Covishield, the AstraZeneca vaccine being developed in partnership with Oxford University.

Yet despite concerns about safety and trial design, countries are already spending billions of dollars [2. 3, 4] in taxpayer funds to purchase AstraZeneca’s vaccine, in part because, compared with frontrunners Moderna and Pfizer, [5. 6]AstraZeneca’s vaccine is easier to store and faster to distribute.

The latest news also hasn’t changed plans by the Global Alliance for Vaccine Initiative (GAVI), a public-private partnership founded by the Bill & Melinda Gates Foundation, to distribute the AstraZeneca COVID vaccine [7] globally, once it’s approved.

Second participant reports neurological adverse effect

On Nov. 21, a 40-year-old participant in AstraZeneca’s clinical trial, who lives in India, sent a legal notice to the Serum Institute of India alleging [8] that the vaccine caused him to develop acute neuro encephalopathy.

In the notice, the participant said he “must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in the future.”

The Serum Institute, which has a deal [9]with AstraZeneca to manufacture a billion doses of the vaccine, maintains [10] that the participant’s medical complications are unrelated to the vaccine trial.

A spokesperson for the Institute said [11] the trial participant is “falsely laying the blame for his medical problems on the COVID vaccine trial” and that “it is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive.”

A statement [12] released by the Institute claimed that they are “sympathetic with the volunteers medical condition” but also that they claim to take legal action against the injured participant for maligning the company’s reputation, seeking damages in excess of $13 million.

On Tuesday,[14] Indian Health Secretary Rajesh Bhushan said that the adverse event “will not affect the timeline in any manner whatsoever.”

Bioethicists and scientists are questioning the ethics of the Serum Institute, which has received at least $18.6 million [13] from the Bill and Melinda Gates Foundation. “This is the first time I have ever heard of a sponsor threatening a trial participant,” said Dr. Amar Jesani, editor of the Indian Journal of Medical Ethics.[15]

Dr. John Jacob, virologist and former professor at Christian Medical College, agreed the actions of the institute were uncalled for. He told [16] the Times of India, “The trial should have been halted the next day after the adverse event was reported. And within a week it could have been investigated. That would have instilled confidence and trust in the minds of people. Stonewalling, refusing to answer, waiting for a lawsuit to bring things out, it speaks volumes about the lack of professionalism.”

This wasn’t the first time a trial participant has complained that the AstraZeneca vaccine caused a neurological injury. In July, a trial volunteer developed [16] symptoms of transverse myelitis, a rare debilitating neurological disorder linked to vaccines.[18]

In September, global trials were temporarily paused [19] after another participant [20] in the UK developed symptoms also consistent with transverse myelitis.

In October, a participant in Brazil died, though in that case, AstraZeneca suggested [21] that the person was part of the control group and thus, according to the Washington Post, hadn’t received the COVID-19 vaccine. The Brazil trial wasn’t paused. [22] Covishield trials are currently taking place [23] in the UK, South Africa, Brazil and Japan.

As reported [24] by The Defender in November, according to the company’s own data [25],  it took only one dose of AstraZeneca’s vaccine during Phase I/II trials in the UK to cause more than 50% of participants to experience adverse events.

If the AstraZeneca vaccine, once approved, does produce harmful side effects and adverse reactions in the U.S., the company won’t be held accountable. In March 2020, the U.S. Department of Health and Human Services issued a COVID-19-specific declaration [26] under the Public Readiness and Emergency Preparedness Act, providing liability immunity “against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures,” including COVID-19 vaccines.

The European Union [27] and Australia [28] have also followed suit, indemnifying vaccine manufacturers from liability.

For more information, see AstraZeneca Under Scrutiny Again as Countries Spend Billions Purchasing Its Low-Cost Vaccine • Children’s Health Defense

[1] Alleging serious side-effects, vaccine trial participant seeks Rs 5 cr from Serum Institute (theprint.in)
[2] https://www.indiatvnews.com/business/news-covid-19-vaccine-serum-institute-of-india-1-billion-dozes-oxford-astrazeneca-635631
[3] https://www.fiercepharma.com/pharma/astrazeneca-scores-1b-from-u-s-signs-up-to-deliver-hundreds-millions-covid-19-vaccines
[4] AstraZeneca nets $396M down payment from EU for 300M-plus COVID vaccines | FiercePharma
[5] RFK, Jr. and CHD Take Action on Safety Concerns over Moderna’s COVID Vaccine • Children’s Health Defense
[6] IBID
[7] AstraZeneca Under Scrutiny Again as Countries Spend Billions Purchasing Its Low-Cost Vaccine • Children’s Health Defense
[8] Alleging serious side-effects, vaccine trial participant seeks Rs 5 cr from Serum Institute (theprint.in)
[9] Ibid
[10]  https://www.bloombergquint.com/amp/coronavirus-outbreak/serum-institute-rejects-charges-levelled-by-vaccine-trial-participant-threatens-to-seek-damages-2
[11] Patient claims ‘adverse event’ in AstraZeneca Covid trial in India | The Independent
[12]vaccine: AstraZeneca & Serum Institute of India sign licensing deal for 1 billion doses of Oxford vaccine – The Economic Times (indiatimes.com)
[13] https://twitter.com/ETNOWlive/status/1333046481100500992
[14] Adverse event’ has not affected timelines of COVID-19 vaccine trial: Health Ministry (yahoo.com)
[15] https://ijme.in/
[16] Covid-19: SII’s threat to sue vaccine volunteer alarms scientists | India News – Times of India (indiatimes.com)
[17]isrctn.com/…-4c8b-97ec-cd85ddfe12fa/38245
[18] The Intertwined History of Myelitis and Vaccines • Children’s Health Defense
[19] AstraZeneca Covid-19 vaccine study is put on hold (statnews.com)
[20] COVID-19 Vaccine Participant Develops Neurological Symptoms, AstraZeneca Pauses Trial • Children’s Health Defense
[21] AstraZeneca COVID-19 vaccine trial Brazil volunteer dies, trial to continue | Reuters
[22] AstraZeneca Covid-19 vaccine study is put on hold (statnews.com)
[23] COVID-19 vaccine AZD1222 clinical trial resumed in Japan, follows restart of trials in the UK, Brazil, South Africa and India (astrazeneca.com)
[24]Leading COVID Vaccine Candidates Plagued by Safety Concerns • Children’s Health Defense
[25] Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial – The Lancet
[26] Federal Register :: Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
[27] COVID-19 vaccine makers see EU shield against side-effect claims | Reuters
[28] Coronavirus Australia: Vaccine suppliers given indemnity for ‘inevitable’ side effects (smh.com.au)