Moderna, a US-based biotech company, has released promising preliminary data from their COVID-19 vaccine trial, moving forward with requesting ‘emergency-use’ approval from the US Food and Drug Administration. Their announcement comes just a week after a similar statement from Pfizer and BioNTech, joining them as trailblazers in the pharmaceutical arena challenging the antigens of this novel virus. However, the long-term safety, efficacy, and accessibility of their candidate for the wider public still needs to be determined.
Launching this Phase III trial back on July 27th, 2020, Moderna has enrolled more than 30,000 participants across 100 clinical research sites in the United States. Participants recruited only consisted of adults aged 18 and above: 42% from populations considered high risk as well as 37% of total participants coming from racial and ethnic minorities. The scientists randomly assigned volunteers to receive either the experimental vaccine, an innovative mRNA design, or a placebo of saltwater. Sticking to the gold-standard, the trial was a double-blind experiment so neither the volunteers nor the people running the trial knew whether participants received the vaccine or the placebo.
The Interim Results
The DSMB, an independent data and safety monitoring board appointed by the National Institute of Health, reviewed trial data, sharing its interim analysis on Nov. 15, 2020. Moderna stated in their press release that the vaccine has an efficacy rate of 94.5% as per the independent data analysis. The DSMB calculated this by looking at 95 cases where volunteers presented with symptomatic COVID-19. Out of the 95, 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. All 11 severe cases of COVID-19 occurred in the placebo group, showing promising results that the vaccine could avert the severity of the disease, helping to avoid hospitalizations and the need for ventilators. The DSMB concluded that the findings have high statistical significance.
Cautions and Considerations
- Price: CEO Stephen Bancel has stated that the company will charge governments between $10 and $50 per dose. The U.S. has secured 100 million doses for Americans at the cost of $15 per dose. The UK has secured 5 million doses, the price of which has not been disclosed. The European Union is reportedly negotiating a deal to keep the per-dose price under $25. It is unclear in what ways this vaccine will be made more accessible to low- and middle-income countries, if at all.
- Shelf-life: the vaccine can stay stable for up to 6 months at minus 20 degrees celsius, 30 days at standard refrigerator temperature, or 12 hours at room temperature. This is welcomed news compared to the minus 70 degrees celsius required from the Pfzier and BioNTech vaccine. This still poses challenges for some facilities in low- and middle income countries, particularly if situated in hotter climates.
- Doses: the vaccine requires two doses in order to reach 94.5% efficacy. It is uncertain whether this protection lasts for life, or if additional doses will be necessary, or if additional doses are even safe and effective.
- Manufacturing: large-scale production is set to be challenging and it will most likely be only in spring 2021, if granted FDA approval, before widespread distribution. Official statements claim that Moderna can have 20 million doses ready by the end of 2020, which would be distributed to 10 million US citizens who are classified as vulnerable persons or are healthcare workers.
- Transmission: At this point, it is uncertain whether vaccinated adults can still transmit the virus to others.
- Age: only people aged 18+ were included in the trial. Moderna is hoping to roll out testing on adolescence in the coming months.
The Key Takeaways
Moderna announced these findings in news releases and not, at least yet, in peer-reviewed scientific journals. Detailed data was not disclosed and so outside experts, other than the DSMB, have not been able to evaluate the claims being made. The interim results cannot be considered conclusive and the figures on effectiveness may change as the studies continue. In addition, the safety of the vaccine regarding the long-term impact on health may also need to be readdressed and certainly monitored.
As the pandemic rages on, this vaccine could present a breakthrough in despair as the virus continues to impact the health of populations and economies across the world. This breakthrough is a welcomed development in the pharmaceutical sphere, as meeting the enormous manufacturing and distribution needs is a feat in which no single biotech company could satisfy alone.
However, and as Dr. Tedros Adhanom Ghebreyesus head of the World Health Organization has noted, “a vaccine on its own will not end the pandemic.” This vaccine compliments the tools already implemented, such as contact-tracing, mask-wearing, and hand-washing, and does not replace these important elements, which still need to be enforced. The success of counteracting this pandemic will also take the willingness of pharmaceutical companies and funding bodies to ensure the accessibility of the preventative medicines they are developing across the globe.
“A vaccine on its own will not end the pandemic.”Dr. Tedros Adhanom Ghebreyesus, Head of the World Health Organization