AMU Diseases Health & Fitness Infectious Diseases

Coronavirus Vaccine Tests Are Set to Seek FDA Approvals

By David E. Hubler
Contributor, EDM Digest

Competition is usually a good way to improve, whether it’s setting a new best time in a race or ratcheting up tennis skills to beat a friendly opponent. And of course, it’s competition in business that not only improves products and services; competition tends to reduce costs for consumers.

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Now we have word that two pharmaceutical companies, Moderna and Pfizer, have developed vaccines that have been shown to be more than 90% effective against the coronavirus.

As Katie Thomas wrote in The New York Times, “The promising news that not just one but two coronavirus vaccines were more than 90 percent effective in early results has buoyed hopes that an end to the pandemic is in sight.”

In normal times, such dual medical advances might engender beneficial competition. After all, whoever is first to market with a new or improved product usually has an edge on capturing a major share of that market. Look what the advent of digital photography did to Kodachrome or Fuji film. Those once ubiquitous yellow and green boxes of film are hard to find these days.

Having Two Prospective Treatments against the Coronavirus Is Far Better than One

Of course, these are not normal times. Having two prospective treatments against the deadly disease is far better than one, with or without competition.

“But it turns out,” Thomas noted, “it’s a lot easier to make thousands of doses for a clinical trial than to churn out millions a month. Making vaccines is a complex, sometimes finicky process, requiring sterile conditions and precise control of temperature and humidity.”

At first glance, it looked like there might be a David and Goliath competition. Pharma giant Pfizer announced last week that its vaccine was more than 90% effective in early analyses. It plans to seek regulatory review within days, according to The Washington Post. The Food and Drug Administration and its outside panel of high-level medical experts are expected to consider the Pfizer data during the second week of December.

On Monday, Moderna, a small Massachusetts drug maker that has never brought a vaccine to market, announced that preliminary results showed its vaccine was 94.5% effective following a large-scale trial. That same FDA panel is likely to review Moderna’s test data the following week.

If this is competition, it is benign at best. The goal is to defeat this worldwide plague that will soon be with us for one year.

Moderna has received more than $2 billion from the federal government to develop and manufacture 100 million doses of its still not FDA-certified vaccine.

Pfizer opted not to accept federal funds to speed up manufacturing. Instead, it agreed to sell the government 100 million doses for $1.95 billion.

Pfizer and Moderna Estimate That by January, They Will Have 45 Million Doses

Between them, Pfizer and Moderna estimate that by January they will have 45 million doses, or enough to vaccinate 22.5 million Americans.

And because both vaccines require two doses for maximum effectiveness, there will initially be enough for only 12.5 million of the current population of 330 million Americans.

So as things now stand, the competition is not between two pharmas, nor is it over money or pricing for consumers. The White House has pledged that the vaccine will be free to all Americans.

Rather, Pfizer and Moderna are competing against the clock to begin vaccinations as soon as possible, perhaps as early as January.

One of the main goals of President Trump’s Operation Warp Speed was to work with drug manufacturers to “pay it forward,” to fund the development of vaccines even before their clinical trials were completed. That way, “millions of doses would be ready to go if a vaccine was successful — something never before tried at this scale,” Thomas explained.

But that goal will not nearly be met, “reflecting just how difficult and unpredictable the manufacturing process has been,” Thomas said.

Dr. Albert Bourla, Pfizer’s chief executive, told the Times that the company can produce up to 50 million doses by the end of the year. Half of that will go to other countries. And because the coronavirus vaccine requires two doses, there will initially be enough for only 12.5 million of 330 million Americans.

Those 12.5 million will most likely be medical staffs, first responders and others who have worked tirelessly to stop the spread and the deaths of the worst public health catastrophe in a century.

David E. Hubler brings a variety of government, journalism and teaching experience to his position as a Quality Assurance Editor. David’s professional background includes serving as a senior editor at CIA and the Voice of America. He has also been a managing editor for several business-to-business and business-to-government publishing companies.

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