Coronavirus One Year On: Vaccines and Trials, Where Do We Stand?, PART 4 OF 4
The last in the Series on Coronavirus will look at The Current Progress of Vaccines and trials targeted against Coronavirus.
The Race for a Vaccine
Worldwide in 2020, scientific research was in a race to develop a Sars-CoV-2 vaccine. There were more than 100 candidate vaccines in development worldwide, and The NY times had even listed a real time Vaccine tracker to track developments.[4]
That race seems to be drawing to a close with Pfizer and Moderna vaccines being approved for use in December 2020.
The Pfizer / AZ MRNA Vaccine
In the US, Pfizer/AZ was evaluating the safety, tolerability, immunogenicity, and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19, throughout 2020.
Latest Update on Pfizer Vaccine 8th of Dec, US time.
On the 8th of December, the FDA approved the Pfizer Coronavirus vaccine following satisfactory results regarding safety and efficacy. The same vaccine was approved for emergency use in Britain, Dec the 2nd, following a report in the Lancet.
The vaccine, which uses innovative mRNA technology, was the first to publish an early analysis from its phase 3 trials involving 43,000 people worldwide.
There were 4 deaths in the placebo arm and 2 in the vaccine, over the course of the trial, all of which were unrelated to the trial itself. Antibody levels were detected after one dose, with future investigations to reveal how long-lasting this is. Patients received 2 doses of the vaccine at day 1 and day 29. It appears at this stage, that atleast 2 injections will be required and that there is 90%efficacy.
The FDA is expected to release a finalised report, within the next few days, however a 53 page report has already been peer reviewed. Dr Anthony Fauci, has indicated that the US will follow with vaccinations in December and todays announcement from the FDA would be key for this becoming a reality.
“When it is, very soon thereafter we are ready to begin administering the vaccine to the higher priority groups,” Dr Fauci told the BBC.
Mass vaccinations could then start in the third or fourth week of December, he said.
Canada will receive nearly 250,000 doses of Pfizer’s vaccine before the end of December, while Angela Merkel’s chief of staff Helge Braun said Germany would likely begin vaccinating its people “in the very first days” of 2021.
Brazil’s São Paulo plans to start vaccinating its population from January 25.
Meanwhile, in Britain Pfizer’s vaccine is already available at 50 hospitals.
Margaret Keenan, a 90-year-old grandmother, was the first person in the world to receive it outside of a trial.
Britain’s National Health Service will give priority to vaccinating people over the age of 80, frontline healthcare workers and nursing home staff and residents.
The immunisation is given in two doses, three weeks apart. Pfizer has said side effects in trial volunteers were mostly mild to moderate, and cleared quickly.
The most severe side effects occurred after the second dose: Fatigue in 3.8 per cent of volunteers and headache in 2 per cent. Older adults tended to report fewer and milder adverse events.
Other Vaccine trials
The Moderna vaccine has also been approved on the 20th of December, with results showing suitable safety and 95 % efficacy. As with the Pfizer vaccine, atleast 2 doses will be required. 200 million doses have been purchased by the US. It has easier transportation requirements than the Pfizer vaccine.
Pertinent Studies and Ongoing Trials Multiple studies globally are investigating the use of Remdesivir, a broad-spectrum antiviral as well as immunomodulation strategies such as the IL-6-targeting therapies Tocilizumab [NCT04317092], Sarilumab [NCT04315298], as previous discussed.
The development of vaccines, will reduce the importance of these studies moving forward.
Where to from Here ?
Currently Coronavirus is going through its second wave from a global perspective, with high numbers of disease in the US, and Europe.
As Coronavirus has been in our lives for 1 year, it is important to stay updated and informed, and to not let complacency creep into management.
Social Implications
Whilst we have discussed the Medical issues of this viral pandemic, there are important Social implications with prolonged quarantine and lockdowns, as well as the impact to livelihoods that are an increasing issue of concern.
As we enter the second year against Coronavirus, there will be an increasing need to balance overbearing restrictions yet still maintain vigilance against the virus.
There may be implications for social acceptance of a vaccine, vaccine availability and measures of efficacy and side effects. These challenges that lie ahead need to be addressed now. The televising of events such as MIke Pence and Biden having vaccine injections, will definitely help in the volatile social envirnoment of public perception of vaccines.
Medical practitioners need to be aware of these issues moving forward, and to start managing them, before they arise rather than when it is too late.
References
1.Widge AT,etal; mRNA-1273 Study Group. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. N Engl J Med. 2020 Dec 3.
2. Coronavirus Resource Centres : WHO, BMJ, NEJM, JAMA, The Lancet.
3. Cascella M, et al. Features, Evaluation, and Treatment of Coronavirus. [Updated 2020 Oct 4]. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2020 Jan-
https://www.ncbi.nlm.nih.gov/books/NBK554776/
4. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
5.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32623-4/fulltext