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Illustration of How the Speed Of Science™ influenced the three speedy approvals of the vaccines.
Big Pharma's goal is to maximize its annual revenue to create astounding numbers for Wall Street. In this chapter of PharmaFiles, you will learn why the key drug approvals for Pfizer's COVID franchise have happened every December for the last three years.
I will use the same 2022 COVID Sales Projection from Pfizer that will net them 54 Billion Dollars this year!!
Let us evaluate two scenarios when launching a drug. First, assuming the S-Curve behaves in the same pattern, what happens when you launch the drug in January (having 12 full calendar months) vs. launching a drug in July (having six full calendar months)?
For a drug with total annual sales of $54 Billion, if you launch it in July (6 months), one usually would assume 50% sales, equating to $27 Billion. However, because of the nature of the S-Curve, it will only bring them $11 Billion (less than 25%) of a full year's sales.
Here, we replicate the exact sales pattern, but we will shift the drug launch to July instead of January. By doing this, you can see this results in Total Sales of only $11.1 Billion, which is 25% of the entire year's $54 Billion,
However, when you launch a drug in January, you get $54 Billion for the entire year.
If you understand this, you will see why Pfizer works with the FDA to get new approvals for COVID drug approvals every December.
Here you see the first COVID Vaccine approved on Dec 11 2020, to maximize 2021 profit.
On Dec 11, 2020, FDA-approved Pfizer-BioNTech COVID--19 mRNA Vaccine was made available under EUA for individuals 16 years of Age and older.
The following year, on Dec 22, 2021, the FDA approved Pfizer-BioNTech COVID-19 Paxlovid under EUA for individuals 16 years of Age and older.
And then, in the following year, on Dec 08, 2022, FDA approved Pfizer-BioNTech COVID--19 Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 months of Age.
Usually, approvals take 6-18 months for evaluation, but this only took two days after they submitted the documentation.
You can see that each of these approvals is timed together to optimize Pfizer's financial results for the following year!
Of course, it doesn't happen with every Drug Launch. They only do it with the Key Drugs that will move the needle in the Profit and Loss Statement because hitting growth targets will guarantee year-end bonuses for the Big Pharma Executives!
Another thing to understand is Drug Approvals, and Drug Launches are two different things. Usually, in the US, when local authorities approve to sell the drug, Big Pharma will immediately make them available the next day. There is considerable coordination between the Supply Chain and Regulatory departments to ensure that once they get the approval, a drug is immediately available at the endpoint (Hospital, Pharmacy and clinic). This is why people get jabbed the day after the press release.
However, this only applies to some countries outside of the US. In some countries, even if they get the approvals early, some will wait to launch. The reason is that there is a practice called “External Price Referencing” (ERP).
Let me explain it.
In certain countries, local authorities determine drug prices by referencing the price of another country. For example, in Taiwan, the authorities will pay the drug price from a basket of ten selected countries, and they will price the drug slightly below the average of the ten countries.
Now, because Big Pharma wants to optimize its revenue, they need to launch drugs in a particular sequence to ensure they get the best drug price in all countries. Therefore, certain drugs are sometimes unavailable in countries outside the US for many months, even though it has been launched in the US.
Below the image, you can see the complexity of ERP for all countries. Usually, there is a team in the Headquarters called the “Price Research” or “Price Optimization” team, and their job is to determine the launch sequence of drugs to ensure optimal prices are achieved for every country.