Will 'speed' COVID-19 vaccine be safe?

Will 'speed' COVID-19 vaccine be safe?


Friday, May 29, 2020

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COVID-19 is taking a serious toll on our lives. When the problem was a hurricane we could rely on remittances. But the sources of the remittances are also suffering, maybe more than we are. And the prime minister can't go begging because the suffering is truly global.

I am anxious for a return to normality for a different reason. It has been proven that social isolation is associated with increased risk of depression, cognitive decline, anxiety, substance abuse, as well as dementia.

In the US, President Donald Trump wants everywhere to reopen immediately. He sees his poll numbers plummeting ahead of November elections and that's all he cares about.

Wall Street, too, is pressuring business leaders for obvious reasons. So everyone wants to have a vaccine...now!

Vaccines have helped eradicate some of the world's greatest scourges. And it would be good if it could rescue us from this one. My concern is that there is such a haste to complete the process that one wonders what we will eventually get.

What I remember is that moving a vaccine through all the stages to the final product is a long, slow process. The general stages of the development cycle of a vaccine are:

1) Exploratory stage

2) Pre-clinical stage

3) Clinical development

4) Regulatory review and approval

5) Manufacturing

6) Quality control

Clinical development, for example, is a three-phase process. During Phase I small groups of people receive the trial vaccine.

In Phase II the clinical study is expanded and vaccine is given to people who have characteristics similar to those for whom the new vaccine is intended. In Phase III the vaccine is given to thousands of people and tested for efficacy and safety. Many vaccines undergo Phase IV after the vaccine is approved and licensed.

The approval process, too, goes through several stages. When a sponsor is found the process proceeds this way:

1) An investigational new drug application

2) Pre-licensure vaccine clinical trials

3) Biologics License Application (BLA)

4) Inspection of the manufacturing facility

5) Presentation of findings

6) Usability testing and product labelling

After approving the vaccine, the Food and Drug Administration (FDA) continues to oversee its production to ensure continuing safety.

I know of vaccines that take eight to 10 years to reach market. An HIV/AIDS vaccine is being worked on for more than 20 years and it is still not ready. I mention all this as word is out that, by some miracle, a vaccine is about to be tested in “weeks”. I shared my concern with my friend, noted dentist Dr Fredrick Foote, my advisor in these matters, who mentions the advent of super computers as one way of reducing time. Indeed, in the US a massive public-private effort called COVID-19 High Performance Computing Consortium has been launched. The consortium's participants are together providing scientists with access to some of the world's most powerful high-performance computing resources in support of COVID-19 research.

According to a White House press release, the supercomputers that are part of the consortium “can process massive numbers of calculations related to bioinformatics, epidemiology, and molecular modelling, helping scientists develop answers to complex questions about COVID-19 in hours or days instead of weeks or months”. My concern about the safety of these new drugs goes back to the 18th century when a Dr John Quier, a British doctor working in Jamaica, freely experimented with smallpox inoculation on 850 slaves during the 1768 pandemic. His experiments did not stop there. He used slaves to explore questions that doctors in Europe dared not with 'valuable' white folk. European doctors wanted to know if infants, pregnant and menstruating women could be inoculated. Quier reported that to answer these questions he sometimes inoculated the same slave repeatedly.

Most Americans only remember the Tuskegee Syphilis experiments, in which the US Public Health Service took 600 poor, illiterate black men, offered them food and medicine to participate in what was supposed a programme to find a cure for the disease. In fact, their real objective was to just study the natural progression of the disease, through sores, seizures, blindness, organ damage, madness, and death, even though penicillin, a cheap, easy, safe cure was available. This continued for 40 years.

By this time interested parties found it less controversial to hop over to Africa to do their trials on black people there. Pfizer went to Nigeria for meningitis tests. Eleven children — whose parents knew nothing of these tests — died. Others suffered blindness, deafness and brain damage.

AZT trials conducted on HIVpositive African subjects by US doctors were not performed with proper, informed consent. Some 17,000 were tested for a medication that was supposed to prevent mother-to-child transmission of HIV/AIDS. These women did not have a clue what their bodies were being used for. Half of them received a placebo ensuring transmission. Over 1,000 babies contracted HIV/AIDS although a proven life-saving regimen already existed.

Although there are now a number of regulatory agencies, my concern is that we are living in an age in which truthfulness and trust in high places are in short supply. Scientists and public servants cannot do their work without political interference. Brilliant public servants and lawmen, who have build up an enviable reputation over decades, seem willing to sacrifice all in obvious fear of a president devoid of the basic principles of truthfulness, accuracy,objectivity, impartiality, fairness, and public accountability. He has shamelessly told over 18,000 lies to the people who elected him since he became president. He has told 59 lies on critical matters directly related to the COVID-19 situation in his own country. He recommends that citizens inject cleaning disinfectants into their bodies and take unproven, unsafe drugs — with a straight face. He is the loudest voice behind this indecent haste for a vaccine for a disease we still do not fully understand.

In the late 1950s a new drug — thalidomide — hit the market. It was thought to be a godsend for pregnant women suffering from morning sickness. Just as mass marketing was to begin in the US, Dr Frances Kelsey, a reviewer with the FDA, ordered a halt. It was not to be sold in the US. Her reason? She rejected the application to market the drug on the grounds that it, “...lacked sufficient evidence of safety through rigorous clinical trials”. That decision saved America and made her a hero. Between 1957 and 1962, thalidomide would result in thousands of infants birthed in Canada, the UK and Germany being born with serious deformities, including the shortening or absence of limbs. In 1960, then US President John F Kennedy praised her at a public function in which she received one of America's most prestigious medals.

But what would be the fate of Dr Kelsey in today's America? All the scientists and technical persons with Dr Kelsey's qualities have been unceremoniously kicked out of their jobs and replaced with a succession of shameless yes-men who nod dutifully when Trump recommends the 'Chlorox chewables'. Elections are due, he needs a vaccine to save himself. There are a number of summonses waiting to be served on him the minute he leaves the White House. Does what we know about this man give us reason to doubt that a 'speed vaccine' can have any number of side effects?

The demographic groups that suffer disproportionally from COVID-19 are the elderly and coloured people — groups low on Trump's scale of importance. Should anyone believe when the purveyors of this speed vaccine tells a pregnant woman that her foetus will be safe after she takes this vaccine? Did this aspect of things go through rigorous trials? Nine months?

In the early stages I think it may be best for us to build up our immune systems, exercise, follow the safety precautions, and sit out the first magic, super computer-generated Trump vaccines.

Glenn Tucker, MBA, is an educator and a sociologist. Send comments to the Jamaica Observer or glenntucker2011@ gmail.com

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