With the speed and frequency of global transport by sea and air involving the mass movement of millions of passengers, on the outbreak of a life-threatening virus there is always the problem of the speed at which a vaccine can be trialled, manufactured and made avail able
First pioneered in the 1990s, mRNA (Messenger Ribonucleic acid) vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration.
Late in 2019, Coronavirus (COVID-19) was first identified in Wuhan, China. As of 2 March 2020, more than 89,000 people across 58 countries had now been diagnosed with the infection, while the death toll globally had exceeded 3,000. The race was on to find a vaccine and the challenge taken up by six drug companies across the world.
As one example, 42 days after receiving the genetic sequence of the COVID_19 virus, called SARS-CoV-2, from Chinese researchers, Moderna Therapeutics, a biotech company based in Norwood, Massachusetts shipped the first batches of its Mrna-1273 vaccine.
Hundreds of vials were sent to the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in Bethesda, Maryland. A team led by Dr Stephen Hoge at Moderna had loaded its vaccine with mRNA that coded for the right coronavirus proteins which could then be injected into the body.
Immune cells in the lymph nodes could process that mRNA and start making the protein in just the right way for other immune cells to recognize and mark them for destruction. Like a software molecule in biology, this vaccine method can be scaled up quickly, saving critical time.
By mid March, human trials had already begun with a group of 45 healthy volunteers getting three doses of the vaccination 28 days apart. They were administered the 25-microgram dose level or the 100-microgram dose level, the low and the middle levels, In May 18 Moderna announced that all 45 participants had developed some antibodies in their blood that bound the virus.
The company began its second phase with The U.S. Food and Drug Administration granting the Moderna Fast Track Designation to begin the mid-stage study soon with 600 patients.. In July 2020, Moderna announced that its Mrna-1273 candidate in Phase 1 clinical testing had led to production of neutralizing antibodies in healthy adults.
Phase 3 could begin. The trial conducted at U.S. clinical research sites, would enroll approximately 30,000 adult volunteers who did not have COVID-19. The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses.
Under a deal with the US Government, worth up to $1.525 billion, Moderna agreed to deliver 100 million doses of its mRNA vaccine candidate if it succeeds in late-stage testing. The deal does not stipulate a timeline for vaccine shipments, at least publicly, but does include “incentive payments for timely delivery,” Moderna says. The pact also includes an option for another 400 million doses. (modernatx.com)
Moderna has not been alone in mRNA research. On November 9th a team led by Mikael Dolsetn at Pfizer Inc of New York and BioNTech SE of Mainz, Germany publically announced their mRNA-based vaccine candidate, BNT162b2, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
Following safety tests on 43,500 people in six countries, a preliminary analysis has shown that BNT162b2 can prevent more than 90% of people from getting Covid-19. The two companies say they will be able to supply 50 million doses by the end of 2020 and around 1.3 billion by the end of 2021. Each person needs two doses.
Pfizer/BioNTech started the phase 3 clinical trial around the same time as Moderna. But while the former give the booster shot for their vaccine 21 days after the initial dose, the latter’s protocol calls for doctors to wait 28 days before giving the second dose.
This vaccine needs to be stored at minus 80c. This could create major logistical challenges for mass treatment outside major urban areas and in low or middle income countries.
On November 16th Tal Zaks, the chief medical officer at Moderna announced that its mRNA-1273 vaccine, remaining stable at minus 20c is able to protect 94.5% of people tested and hopes to have 20 million doses available in the USA, with one billion doses worldwide.
It has since been authorized in Europe (EMA), the USA, Canada. Hundreds of millions of doses will soon be administered.
There are of course several other serious contenders in the race to obtain efficient and reliable COVID-19 vaccines.
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