COVID-19’s Status in the US
As the US struggles to manage the outbreak of coronavirus, the US Food and Drug Administration has issued an emergency use authorization for convalescent plasma to treat COVID-19. Reportedly, over 70,000 patients have been treated with the blood and plasma of those who previously recovered from the infection since the pandemic started and have responded positively to the new treatment.
While this authorization has been touted as a “historic breakthrough”, scientists say additional data is necessary, citing the misleading statements by Trump overstating the limited evidence behind the new therapy. Documented positive outcomes of individuals being treated with convalescent plasma is encouraging when developing therapies to treat COVID-19, but widespread emergency use is still uncertain
Operation Warp Speed (OWS), first introduced over the summer, is the Administration’s operational goal of creating a vaccine for the coronavirus at a considerably faster rate than traditional vaccines. Trump and his team are pushing for a vaccine to be effective and ready for mass distribution before the November 3rd election day. Such an accelerated timeline requires pharmaceuticals and manufactures to work faster and more funding to support their efforts, the Administration has already committed billions of dollars to the vaccine pursuit.
|Manufacturers||Country||Type of Vaccine||Current Phase||Notes|
|Moderna and National Institutes of Health (NIH)||USA||Messenger RNA (mRNA)||Phase III||US Govt initially funded nearly $1 billion, was given an additional $1.5 billion in exchange for 100 million safe and effective doses.|
|University of Oxford & AstraZeneca||UK & Sweden||Viral Vector||Phase III||First vaccine to reach Phase III. The US awarded the two $1.2 billion in May and in Aug, the European Union ironed out a deal for 400 million vaccine doses. On Sept 6 trials were halted after a participant experienced severe neurological symptoms, trials in the UK and Brazil resumed on Sept 12, others are still paused.|
|Johnson & Johnson, & Beth Israel Deaconess Medical Center||USA||Viral Vector||Phase I/II – moving to phase III in late Sept.||In March, the two received $456 million from the US government and a contract of $1 billion for 100 million doses if the vaccine is approved, back in August.|
|Pfizer, BioNTech, & Fosun Pharma||USA, Germany, & China||Messenger RNA (mRNA)||Phase II/III – there are currently two versions of the vaccine.||Trump Administration awarded a $1.9 billion contract for 100 million doses by December, Japan made a deal for 120 million doses and the European Union arranged 200 million doses. Company executives said they should know by October if the vaccine works.|
|Sinopharm & Beijing Institute of Biological Products||China||Inactivated Coronavirus||Phase III||Given emergency approval in the United Arab Emirates on Sept 15. The vaccine is authorized to only be used on healthcare workers.|
|Gamaleya Research Institute||Russia||Viral Vector||Phase III||The vaccine, renamed Sputnik V, is approved for early use. At first, little was known or shared about this vaccine. The globe was surprised by Putin’s announcement that a vaccine had been approved when few knew one was being developed, back in August.|
Recently CNN reports that nine vaccine makers say they have signed a joint pledge to uphold “high ethical standards,” suggesting they won’t seek premature government approval for any Covid-19 vaccines they develop. The companies that signed the pledge include AstraZeneca, BioNTech, Moderna, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson and Merck.
The emergency authorization announcement came on the eve of the Republican National Convention, where Trump is attempting to resurrect his struggling polling numbers and popularity. It can be assumed that if Trump is viewed as finding a solution to the current pandemic, his favorability will increase, and the chances of reelection are higher. However, pushing a treatment before it has been fully tested can have disastrous effects, can dissuade supporters, and negatively impact future trust in treatments and vaccines. Scientists should explore this treatment as a viable option in treatment, but until a thorough study is conducted, it should not be touted by the President as a golden ticket out of the pandemic.
As with the emergency authorization of convalescent plasma, many see the rush for a vaccine as risky. While many of the manufacturers are reputable, the idea of cutting down a vaccine development process by half promotes uncertainty. This is particularly dangerous when it comes time for mass vaccinations.
AstraZeneca has come into the forefront of this race for a vaccine, but their trial hit a small bump in the road. After a participant began experiencing severe spinal cord inflammation, the trial was tentatively halted. Following protocol, researchers were tasked with determining if the symptoms were a result of the vaccine or if this was an unrelated occurrence. This suspension comes after another participant was dismissed from the trial after too experiencing neurological symptoms. However, it was concluded that the participant had anundiagnosed case of multiple sclerosis, and the vaccine was not to blame. The trial continued September 17th in the United Kingdom and Brazil, other nations where testing is underway are still on pause. Currently, there are plenty of vaccines racing to bring this pandemic to an end, until one is deemed safe and effective, and gain approval, the race shall continue.
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