Response To NY Times Article: Part 1 — Dr Musa Mohd Nordin

All the Chinese and Russian Covid-19 vaccines “published in peer-reviewed scientific journals” were Phase 1 and 2 clinical trials; only an interim analysis of Phase 3 trials of the Russian vaccine has since been published.

This New York Times piece has been around since February 5, 2021, but it only gained currency during the last one or two days. I think there is an agenda to mainstream the Chinese, Russian and Indian home-grown vaccines.

I have no issues with any candidate vaccines, provided they are based on sound evidence tested in Phase 3 Randomized Clinical Trials (RCT) published in peer reviewed scientific journals.

I will examine this article carefully, and hopefully it will help to shed some light on the science of vaccinology and not be swayed by the politics of pandemics, which I am afraid has been the powerful undercurrent influencing national decisions on pandemic management and the choice of national Covid-19 vaccine programmes. 

“When those countries vetted these vaccines, they made informed decisions, based on evidence about safety and efficacy released by the Chinese and Russian manufacturers — much of it also published in peer-reviewed scientific journals.”

“To assume otherwise is to doubt the ability or integrity of these governments, some of which have health regulatory systems on par with those in the United States or Europe.”

As I had anticipated, all the “published in peer-reviewed scientific journals” were Phase 1 and Phase 2 clinical trials. I have listed them here for your kind perusal.

Study: Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, Phase 1 and Phase 2 clinical trials.

Study: In this interim report of the Phase 1 and Phase 2 trials of an inactivated Covid-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require Phase 3 trials.

Study: Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost Covid-19 vaccine in two formulations: two open, non-randomised Phase 1 and Phase 2 studies from Russia.

I would definitely question the capability and integrity of the national regulatory that based their pivotal vaccine decisions on Phase 1 and Phase 2 trials. It is these decisions that negatively impact vaccine confidence and play into the hands of the anti-vaccine lobby.

Only the Russians have since published their adenovirus vector vaccine Sputnik V interim analysis of their Phase 3 Trials.

What is even more disconcerting within the scientific fraternity is that China and Russia began using their Covid-19 vaccines in the middle of 2020, without safety and efficacy results from Phase 3 clinical trials.

This unlike the Emergency Use Authorization (EUA) approvals of the Pfizer-BioNTech and Moderna vaccines in December 2020 only after review of interim results from their Phase 3 trials by the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency.

The Indian inactivated vaccine Covaxin, made by Bharat Biotech was similarly rushed by the Indian regulatory bodies, whose Phase 3 trials interim analysis are not due until late March 2021.

The price of Covaxin, priced at Rs 295 (RM16.70) per dose, was much more expensive than the World Health Organization pre-qualified vaccine Covishield (AstraZeneca equivalent), priced at Rs 200 (RM11.30) per dose.

I assume you can guess who are the beneficiaries of these kickbacks.

I suspect similar unethical and corrupt practices are prevalent elsewhere. This constitutes criminal profiteering, and puts lives at stake before meticulous scientific evaluation of the safety and efficacy of candidate vaccines.

  • This is the personal opinion of the writer or publication and does not necessarily represent the views of CodeBlue.

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