By World Healthcare Journal-
Earlier this week, the Chief of the US Food and Drug Administration (FDA), Stephen Hahn, announced that they are prepared to bypass the full federal requirements to put a Covid-19 vaccine into circulation as soon as possible.
The Centres for Disease Control and Prevention (CDC) have now instructed US states to prepare for a vaccine rollout as soon as 1st November, just two days before the Presidential election.
In addition, the UK Prime Minister Boris Johnson has announced that the existing laws surrounding coronavirus in Britain will be updated to allow for the emergency use of an effective Covid-19 vaccine before it has been fully licensed for use.
US President Donald Trump announced in his speech at the Republican National Convention that he aims to procure and distribute a vaccine before the end of the year, or perhaps sooner through the use of an EUA (Emergency Use Agreement) as reported by the Financial Times.
Many experts previously believed that this was simply political posturing from Trump for the upcoming election in November, and his chances of realistically pushing a vaccine through so quickly without full safety testing were slim.
But with these announcements from the FDA and the CDC, as well as this move by the British government, the world moves ever closer towards reaching a coronavirus vaccine that could potentially save hundreds of thousands of lives, protect the vulnerable, and enable economies to reboot with no holds barred.
FDA Chief Stephen Hahn has also denied he is acting under pressure from President Trump, stating that any vaccine approval would be based in “science, medicine, and data".
Furthermore, the UK and the US are not the only nations who have been tirelessly working towards developing a Covid-19 vaccine. At present, there are 250 vaccine candidates currently in varying stages of development, testing, and approval.
Russia, notably, has already granted regulatory approval for their Covid-19 vaccine “Sputnik V” after less than two months of testing. The Russian Government has also announced that they have successfully “registered the first vaccine in the world” against Covid-19.
This initially prompted fear from health experts as to the potential negative side effects or effectiveness of the vaccine - but Russian President Vladimir Putin is extremely confident in the vaccine, even disclosing that his own daughter has participated in the vaccine trials.
“As far as I know, this morning the first vaccine against the novel coronavirus infection in the world was registered,” said Putin last month.
He continued to say: "I would like to repeat that it has passed all the necessary tests. The most important thing is to ensure the full safety of using the vaccine and its efficiency."
The effects of the Russian vaccine are similar to other trials around the world, producing mild symptoms, including fever, which then dissipate after a few days.
"She's feeling well and has a high number of antibodies," Putin added, commenting on his daughter’s experience with the vaccine.
Despite these rapid moves from the US and the UK, not only is the safety of the vaccine a major issue - but the logistics of physically producing the vaccine in such large quantities and transporting them pose enormous challenges.
DHL recently authored a white paper on the logistics of distributing a Covid-19 vaccine. Normally, the paper said, the timeframe for developing and adequately testing a vaccine can take anywhere from 5-20 years.
But the testing itself is not centred solely on the safety and efficacy of the vaccine.
Key factors such as stability, hardiness, and longevity are all taken into account - and are much harder to evaluate on such a pressing schedule.
“Under non-pandemic conditions, sufficient time is devoted to testing and developing vaccine stability, which is key to determining the environmental conditions under which the vaccine can be transported and stored,” reads the DHL white paper.
“In the current pandemic, however, researchers are focusing on safety and efficacy, and are seeking EUAs and fast-track approvals for their vaccines to put them to use as quickly as possible. ”
“When vaccines enter the market for emergency use (potentially as early as Q4), a potential lack of stability data might mean stricter temperature requirements for the vaccine supply chain. ”
Tightening the requirements for adequately transporting a Covid-19 vaccine could prove to be enormously challenging for the logistics industry - and this knock-on effect could dramatically impact how quickly, and safely, a vaccine is able to be distributed.
Overall, the challenges surrounding a Covid-19 vaccine number in many, and the risks are still very high. However, waiting long lengths of time for a vaccine will only exacerbate existing problems, and continue to leave us trapped and fearful of coronavirus.
The big question is - will rushing out a coronavirus vaccine be worth it in the long run?
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