While the pandemic is raging for the second time this year, pharmaceutical giants are giving the world hope of ending the COVID-19 nightmare. On Monday, Moderna Inc MRNA said it will apply for U.S. and European emergency authorization of its vaccine candidate as late-stage study results showed its vaccine was 94.1% effective without any serious safety concerns.
Moderna Is One Week Behind Pfizer, But Its Candidate Comes With A Significant Advantage
With a 100% success rate in preventing severe cases, the efficiency is consistent across age, race, ethnicity and gender demographics. There were no new side effects since the interim analysis on November 16th. The most common side effects were fatigue, injection site redness & pain, headache, and body aches, which increased after the second dose but were short-lived. Considering such a potent vaccine, these flu-like symptoms are expected.
The filing that came a week after Pfizer Inc. PFE and its German partner BioNTech SE's BNTX, sets Moderna's candidate to be the second vaccine likely to receive U.S. emergency use authorization this year. Both candidates use a technology called synthetic messenger RNA (mRNA) that showed an effectiveness of approximately 95%.
Both the Moderna and Pfizer vaccines proved more effective than anticipated and far superior to the 50% benchmark set by the U.S. Food and Drug Administration. But, Moderna's distribution is expected to be easier to store than Pfizer's. It does require a freezer, but not the ultra-cold temperature needed by Pfizer's vaccine.
Just like other vaccine developers, Moderna will begin a new trial aimed at adolescents before the end of the year, followed by another trial in even younger volunteers at the beginning of next year. It expects the adolescent version of the vaccine to be available by September next year.
Pfizer's Vaccine Comes With Challenges
The excitement over Pfizer and BioNTech's vaccine developments has been hampered by some harsh realities. While a marvelous scientific discovery this new technology is, this particular vaccine has significant obstacles to overcome if it wants to contribute in putting an end to the global pandemic. Besides the regulatory approval, distributing and administering this vaccine across the globe may not be the walk in the park the markets seem to assume.
The overall trial counts over 40,000 participants, but the impressive efficacy is based on 170 individuals so we need to wait and see will this rate hold as numbers increase.
The duration of effectiveness is also unknown. Usually, vaccines are not approved unless they offer protection for at least one year. But, these are everything but normal times so this factor won't hamper the regulatory process. Yet, there are production, distribution, and administration issues to consider.
It's much easier to make a small batch of mRNA for a clinical trial than it is to make millions and billions of doses that are to be distributed worldwide.
In May, Pfizer got valor glass containers by Corning Incorporated GLW to prevent contamination and enable smooth high volume production. But Messenger RNA is very unstable, and these will be the very first mRNA vaccines that are approved for human use. The vaccine is required to be stored at cold temperatures due to this instability. Moreover, Pfizer's vaccine must be kept at a temperature colder than in Alaska. Moreover, the negative 94 degrees Fahrenheit that the vaccine requires has not even been recorded in the U.S.
Given the complex requirements, the company has chosen to distribute its own vaccine rather than rely on the government. To ship the vaccine from its Wisconsin or Michigan manufacturing sites, Pfizer developed a special suitcase. This so-called ‘pizza-box' allows temperature and location to be tracked at all times. But the necessary temperature can be kept with the help of dry ice only for 10 days. Moreover, the suitcase can only be opened twice per day for less than three minutes at a time.
These freezers are not cheap, nor easy to find. They cost about $20,000. Thankfully, Walgreens Boots Alliance Inc WBA and CVS Health Corp CVS stated they are up to the task.
Administering the Pfizer vaccine is also somewhat of a challenge as the vaccine must be mixed at the administration site with a sterile liquid, usually water, and given within six hours of creating the solution. Therefore, it is hard to decentralize the administration. At the very least, nursing homes, where nearly a third of COVID deaths have occurred, have been covered by CVS which pledged to administer the vaccine as soon as it has been approved.
Despite the current situation, the U.S. is fortunate regarding the vaccine whereas Australia, despite being a developed economy, will have to figure out a way how to get this vaccine across the globe to its citizens in less than 10 days.
AstraZeneca Caused A Lot Of Head-Scratching
Britain's AstraZeneca plc AZN and the University of Oxford announced an average efficacy rate of 70% for their candidate, with the rate increasing up to 90% for a subgroup of trial participants who got a half dose/full dose treatment. But, some scientists have expressed doubts as it remains puzzling why immunization was more effective in trial participants who received a lower dose.
There are issues that the potential candidates are yet to overcome to reward shareholders and save lives. But the past few weeks of positive developments brought hope for ending the pandemic that has beaten economies to the ground and claimed more than 1.45 million lives across the globe. Good news comes at a time when new COVID-19 infections and hospitalizations are at record levels. Independent advisers to the U.S. Food and Drug Administration are scheduled to meet on December 10th to review Pfizer's data, with Moderna's following up on December 17th. The world will be eagerly waiting for their recommendations to the FDA. But regardless of the outcome of those reviews, it is certain that it will take a while for 2021 to be the year when life went back to normal.
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