When Clinical Tests Reveal Hidden Risks

 

As the President has forced a pre-order of a vaccine (over 100 million units) way before any semblance of adequate clinical tests have been completed – under the catchy name of Operation Warp Speed – he has put pressure on theoretically neutral federal protectors of the health and safety of a nation to waive normal testing requirements. With the Food and Drug Administration and Centers for Disease Control kowtowing to the President’s direct political interference, in abrogation of their statutory mandate, we could face a litany of risks and unintended consequences should that vaccine be released too soon. Think that’s out of the question?

So far clinical testing of the leading vaccine contenders here in the United States has still failed to generate sufficient tests, particularly with certain segments of the population including different racial and ethnic groups or the very young or elderly.  The consequences of those missing test subjects pose a very serious risk. Would our government really allow that risk to happen? The obvious answer is resounding yes. This has become a political and not a medical or scientific decision process. It’s no coincidence that the announced target release date, which experts (including in the federal government) tell us is exceptionally unlikely, is two days before the November 3^rd election.

In an administration that often operates under falsely represented agendas shrouded in secrecy, we are unlikely to see a full and transparent release of the clinical process and test results. We are forced to generate a common sense of the risk here in the United States by looking at comparable studies of other advanced vaccine development in other high credibility countries that parallel our own. Like the United Kingdom.

“Final clinical trials for a coronavirus vaccine, developed by AstraZeneca and Oxford University, have been put on hold after a participant had a suspected adverse reaction in the UK… AstraZeneca described it as a ‘routine’ pause in the case of ‘an unexplained illness.’… The outcome of vaccine trials is being closely watched around the world.

“The AstraZeneca-Oxford University vaccine is seen as a strong contender among dozens being developed globally… Hopes have been high that the vaccine might be one of the first to come on the market, following successful phase 1 and 2 testing… Its move to Phase 3 testing in recent weeks has involved some 30,000 participants in the US as well as in the UK, Brazil and South Africa. Phase 3 trials in vaccines often involve thousands of participants and can last several years.

“The New York Times is reporting a volunteer in the UK trial has been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and can be caused by viral infections… However, the cause of the illness has not been confirmed and an independent investigation will now work out if there was any link to the vaccine.

“At first glance this may seem alarming. A vaccine trial - and not just any vaccine, but one receiving massive global attention - is put on hold due to a suspected serious adverse reaction. But such events are not unheard of. Indeed the Oxford team describe it as ‘routine.’ Any time a volunteer is admitted to hospital and the cause of their illness is not immediately apparent it triggers a study to be put on hold.

“This is actually the second time it has happened with the Oxford University/AstraZeneca coronavirus vaccine trial since the first volunteers were immunised in April. An Oxford University spokesperson said: ‘In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.’

“A final decision on restarting the trial will be taken by the medical regulator the MHRA [the Medicines and Healthcare products Regulatory Agency, the UK equivalent of the US’ FDA], which could take only days. But until then all international vaccination sites, in the UK, Brazil, South Africa and the USA are on hold… The Oxford University team believe this process illustrates that they are committed to the safety of their volunteers and the highest standards of conduct in their studies…

“US President Donald Trump has said he wants a vaccine available in the US before 3 November's election, but his comments have raised fears that politics may be prioritised over safety in the rush for a vaccine… [To try and counter global skepticism of US efforts, on] Tuesday [9/8], a group of nine Covid-19 vaccine developers sought to reassure the public by announcing a ‘historic pledge’ to uphold scientific and ethical standards in the search for a vaccine.” BBC.com, September 9^th.

The pressure to skip over vital testing is coming from the same Donald Trump who suggested the internal use of bleach and use of hydroxychloroquine as possible cures for COVID-19… the same Donald Trump who has pressured all of those in his administration to talk about the pandemic in the past tense, even as the outbreak continues unchecked. As well north of fifty thousand college students, just having arrived on campus, have already tested positive for the virus. The pandemic is actually going in the opposite direction in many US regions. This, just before the Labor Day weekend:

“Covid-19 cases are on the rise in 22 states, causing health officials to worry that a long holiday weekend of travel and social events could led to a surge in infections similar to what happened during July and August in the wake of Memorial Day. That explosion in cases was concentrated across the Sunbelt in the South and West, but now, the rise is located in less-populated states in the Midwest and Plains.” Barron’s, September 6^th.

So, in the United States, “Skepticism about getting a coronavirus vaccine has grown since earlier this summer, and most voters say if a vaccine were made available this year, their first thought would be that it was rushed through without enough testing… Just 21% of voters nationwide now say they would get a vaccine as soon as possible if one became available at no cost, down from 32% in late July. Most would consider it but would wait to see what happens to others before getting one. 

“Two-thirds of voters think if a vaccine were announced as soon as this year, their initial thought would be that it was rushed through without enough testing, rather than a scientific achievement that happened quickly. Among those who feel it would have been rushed, just 13% say they would get a vaccine for the coronavirus as soon as possible if one were available.” CBS News, September 6^th. One wag has suggested that the vaccine first be tested on members of the Trump administration and their supporters in Congress. No matter the result, they say, the nation would be better off. And remember, without widespread deployment of an effective vaccine, herd immunity is just not happening.

            I’m Peter Dekom, and that federal health agency leaders are willing to accept the political dictates of a science-denying president over their sworn duty to protect the health of a nation should result in their criminal prosecution.