Will you take a Covid vaccine? It’s a question that is set to occupy us soon if the two first possible candidates from Pfizer and Moderna are licensed.
For decades, vaccine researchers have been enchanted and frustrated with the promise of messenger RNA. The tiny snippets of genetic code are essential in telling cells to build proteins, a basic part of human physiology — and key to unleashing the immune system.
But they’ve been hard to tame, at least until the coronavirus spurred a global race to create a vaccine.
Now, both Pfizer and Moderna are testing their separate vaccine candidates that use messenger RNA, or mRNA, to trigger the immune system to produce protective antibodies without using actual bits of the virus. If the experimental coronavirus vaccines win approval from the US Food and Drug Administration, they will be the first-ever authorised vaccines that use mRNA — a development that could not only turn the tide in this pandemic but could also unlock an entirely new line of vaccines against a variety of viruses.
Dr Piotr Kowalski, an emerging investigator for health and a special lecturer in advanced therapies at University College Cork’s School of Pharmacy, is also an inventor of two patents on RNA delivery technologies, so he is not surprised by the success of both companies.
He said the traditional vaccines utilise the inactivated virus or antigen protein itself, manufactured in a cell-based process that takes months to set up and run. “With mRNA vaccines, the patient’s own body becomes the antigen factory.” The speed with which mRNA vaccine candidates can be designed and produced is a key advantage of this new vaccine technology.
“For Moderna, it took a total of 25 days from sequence selection to vaccine manufacture.” Everybody is looking for the scientific clinical data–which has yet to be released–but so far the information from both companies is promising, he said.
Dr Kowalski said in terms of reported side effects, both are mild or moderate, and there is nothing more concerning compared with established vaccines.
Country star Dolly Parton has said she feels “very honoured and proud” to have given US$1m to Vanderbilt University Medical Center in Nashville as one of the trial sites for the Moderna vaccine.
“I’m sure many millions of dollars from many people went into that, but I just felt so proud to have been part of that little seed money that will hopefully grow into something great and help to heal this world.”
Both Moderna and Pfizer say they have had no “serious safety concerns” so far, but will continue to examine data. Reported side effects, such as a sore arm or fever, are common to many vaccines.
Nevertheless, a major education campaign will be needed and the anti-vax campaigners are already out on social media. Health workers will be among the first to be offered the vaccine, and it would reassure a lot of people if senior doctors were to be seen getting the two-dose injections.
He said the one benefit that has come out of this technology is the speed at which the companies could deliver a vaccine. Dr Kowalski believes there will be no shortcuts in how the vaccines will be evaluated by regulatory authorities.
The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna. Moderna has reported its vaccine is 94.5pc effective.
Juan Andres, chief technical operations and quality officer at Moderna, said: “We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to six months at -20C, including up to 30 days at normal refrigerator conditions after thawing, is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination.”
There is much work going on behind the scenes and we can expect more exciting developments in the coming weeks as Pfizer and Moderna prepare to submit their applications for emergency authorisation. It has been announced that the European Medicines Agency (EMA) human medicines committee has started a rolling review of Moderna’s vaccine candidate against Covid-19.
Stéphane Bancel, chief executive of Moderna, said: “The start of the rolling review process marks an important next step as we continue to advance mRNA-1273 in collaboration with European regulatory authorities. We are scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.” It is unclear how long it will take for both vaccines to go through the regulatory process.
There are a number of other promising vaccinations under development in recognition of the significance, both in terms of the human and financial implications of success. Amongst others, trials are continuing in China and at the University of Oxford while early results from trials of a Covid vaccine developed in Russia suggest it could be 92% effective. The Sputnik V vaccine, developed at the National Research Centre for Epidemiology and Microbiology in Moscow, is currently going through phase III clinical trials in Belarus, UAE, Venezuela and India.
WHO Director-General Tedros Adhanom Ghebreyesus said in October there are more than 100 COVID-19 vaccine candidates under development, “this is the largest portfolio of potential COVID-19 vaccines and the most effective way to share safe and effective vaccines equitably across the world, equitably sharing of vaccines is the fastest way to safeguard high-risk communities, stabilise health systems and drive a truly global recovery.”
Thailand, along with many countries worldwide are setting aside funds to procure doses of an approved vaccine. Thailand’s National Vaccine Committee is to request nearly 3 billion THB in order to procure enough doses of a Covid-19 vaccine for half its population, beginning with frontline healthcare workers. The aim is to acquire enough doses to vaccinate 33 million people, roughly half the population. Health Ministry spokeswoman Panprapa Yongtrakul says officials are looking at producers who have finished phase 3 trials, of which there are currently around 10, in the US, the UK, China, and Russia.
Professor Eleanor Riley, from University of Edinburgh, worries the data has been rushed out too soon. “This is not a competition. We need all trials to be a carried out to the highest possible standards,” she said.
If they are licensed, an unprecedented global rollout will get under way and it will be the start of a long road on the fightback against the virus that has upturned our world.
Editor’s Note: This article has been compiled by the RCR from multiple reputable sources as a comprehensive, though incomplete, report on current Covid-19 vaccine developments.