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Like all things, the COVID-19 crisis will come to an end. That’s not to say that the virus will be completely irradicated, but with a vaccine, we will be able to resume the lives we had before March 2020.
To some extent.
But the promise of a safe and effective vaccine is being questioned, not only because Trump mishandled the pandemic, but from the fear that political consideration may have influenced the vaccine’s premature approval.
Nothing comes before money or power. Not even a pandemic.
In addition to the political considerations, there’s the fact that the process of developing the vaccine was expedited. Normally, there are several phases. But during a pandemic, the FDA can mandate “emergency use authorization” before the final formal approval.
Here’s what a normal time-line looks like.
Phases of Clinical Trials
This is what researchers call basic science or the animal phase. The substance is injected into a lab rat, guinea pig, or some other poor unsuspecting creature.
Phase 1 — Safety Trials
A small number of people, volunteers, are given the vaccine to test the safety and confirm that it stimulates the immune system.
Phase 2 — Expanded Trials
The vaccine is given to hundreds of people in different groups, children and the elderly, to see how it affects them. They are again monitored for safety and to be sure it stimulates the immune system.
Phase 3 — Efficacy Trials
The vaccine is given to thousands of people to see how many become infected compared to the volunteers who receive a placebo. The protective effect is determined. The Food and Drug Administration (FDA) wants to see a 50% rate of protection. This is also the phase that has a large enough group to reveal side effects.
Early or Limited Approval
If the substance passes through the third phase, it receives limited approval for distribution.
Of note here is the fact that China and Russia skipped Phase 3 trials of the COVID-19 vaccine and went right to approval. They will not know if it has a protective effect or negative side effects until it is administered to the entire population.
This is the final phase. Regulators in each country review the results before approving and distributing. It is still monitored after licensing.
To speed up development, as in the instance of a pandemic, some phases are combined. For instance, Phase 1 and 2 can, and did, involve hundreds of people.
Any phase can be paused if troublesome symptoms develop. It is investigated and the trial can be continued or stopped.
Operation Warp Speed
Here’s the political side.
Rep. James E. Clyburn, Chairman, a Democrat and member of the U.S. House of Representatives from South Carolina, and also Chair of the House Selective Subcommittee on the Coronavirus Crisis, released documents showing “significant conflicts of interest” among top advisors of Operation Warp Speed.
Operation Warp Speed is Trump’s multibillion-dollar public-private development plan to distribute 300 million doses of the vaccine by January 2021. Amongst these top advisors is Moncef Slaoui, Chief Scientific Advisor. He is also the former head of vaccines at GlaxoSmithKline (GSK) where he was employed for 30 years.
It is not his expertise that is being questioned.
It is a conflict of interest.
Slaoui was a board member of Artizan Biotech., Clasado Biosciences, Lonza, Moderna, and ViceBio, Ltd. Health and Human Services claim that he divested his equity holdings in Moderna and resigned his seat prior to the announcement of his position as the Chief Scientific Advisor.
They also claim that he resigned from Lonza, the contract manufacturer that was helping Moderna make the vaccine.
Operation Warp Speed awarded GSK and Sanofi a contract worth upwards of $2.1B for their collaboration. Slaoui’s retirement is GSK stock. And guess what? He refused to give it up.
Investment decisions are recommended by the Operation Warp Speed Board of Directors which include the Secretaries of Health and Human Services, the Department of Defense, and the White House COVID-19 Task Force Personnel.
Slaoui was hired as a consultant, not a federal employee, and is therefore not required to go through the Office of Government Ethics training process. The process requires disclosure of any conflict of interest, and although Silaoui’s documents were made public, much of the information was redacted.
It’s no secret that financial considerations might be put ahead of public safety. However, Silaoui claims that the data from both Moderna and Pfizer are transparent and promising.
And Fauci agrees.
“Pfizer’s vaccine developed in collaboration with Germany’s BioNTechSe has: “an extraordinarily high degree of efficacy, more than 90%, close to 95%.”
But efficacy and safety are two different issues.
The Case for Safety
New York Governor, Andrew Cuomo, will not be taking the vaccine until an independent panel has tested it. He cites a lack of trust in the President and fears that political considerations influenced its speedy approval. However, he states that “I have trust in the drug companies.”
And there have been side effects.
In September, the FDA considered halting the COVID-19 vaccine trial when an AstraZeneca volunteer in the trial was hospitalized with transverse myelitis, i.e., damage to the spinal cord damage. Transverse myelitis causes inflammation along the spinal cord and can cause pain, muscle weakness, and paralysis.
Yes, the volunteer recovered and was released.
But this is just one case, and who knows if there are others.
What’s the ordinary person to do?
So the dilemma is, when this vaccine is available, do we take it and run the risk of serious, undisclosed side effects and remain defenseless against COVID-19? Or do we stand in line with New Yorkers, refuse the first batch, and wait until we can be certain of its safety?
There could be some rare or insignificant side effects and waiting to get the vaccine may present an even greater risk. It’s a tough decision and the risks with either one can be devastating.
In the land of the free, it’s up to each individual to decide, but it’s everyone’s personal responsibility to help stop the spread of COVID-19. So until there is a vaccine:
- Wear a mask when you’re not at home.
- Social distance — stay at least six feet apart and socialize outdoors whenever possible.
- Limit your time at indoor events with people you don’t live with and avoid indoor spaces that are crowded or have poor ventilation.
- Wash your hands.
We want to make it out of this pandemic alive and healthy.
Hope to see everyone on the other side of this.