IO – In two weeks, the US Food and Drug Administration (FDA) will meet. To be precise, on December 10, 2020 which happens to coincide with `Human Rights Day.
The body will discuss the permit application, sent last Friday, by the drug manufacturer Pfizer. The USbased pharmaceutical giant has officially sent a letter requesting authorization for emergency use of its Covid-19 vaccine.
FDA previously said it would streamline the licensing process without sacrificing quality of safety of the recipients. Based on this statement, analysts in America predict that the emergency use clearance will be issued before the end of December 2020. If so, this will be the sweetest Christmas and New Year’s present for the American people.
If this scenario plays out, it means that America, not China, will be the first country to conduct mass Covid-19 vaccination. This is all made possible because of the Operation Warp Speed (OWS). Helming the operation was a 4-star army general named Gustave F Perna. He specializes in logistics and equipment, including being the Director of Logistics of US Forces in Iraq.
OWS received a funding allocation of around Rp150 trillion. One of the aims is to provide support for 14 US-based drug companies in the search for a Covid-19 vaccine. These 14 companies are chosen from more than 100 companies vying for the government’s research funds.
Of the 14 companies, Pfizer is a leader. The company last week issued a statement that its vaccine efficacy is up to 95 per cent. And they are not boasting. Last Friday, it has sent its clinical trial data to the FDA for emergency use authorization.
A 95 per cent effective rate means that out 100 people who received the vaccine injection, 95 are proven to show immunity to the coronavirus. But in practice it will be lower. The 95 per cent rate is based on a control group who took part in the clinical trials. This means that they have been selected for the experiment, while in mass vaccination the vaccine recipients are the general public, with varying conditions.
The high effective rate indicates that the permit will be issued immediately. Why? Because it is far above expectations. The FDA has promised to speed up licensing for manufacturers capable of finding a vaccine, even if it’s just over 50 per cent effective. That is the commitment FDA made during OWS meetings.
For China, it appears that the country will not “greenlight” its own vaccines before they are approved by the World Health Organization (WHO), even though China discovered the Covid-19 vaccine earlier than the US. There are three Chinese companies competing to reach the finish line in the phase-three clinical trial.
Indonesia, which has already decided to use a vaccine from China, also seems to be on the wait-andsee. Indonesia certainly won’t dare vaccinate its people without a WHO permit.
Now back to the US. How can a mass vaccination start in January? Doesn’t the permit have to wait until Christmas? When will the production plant be built? When will the production start?
That is where General Gustave F. Perna comes in. As COO of OWS, he dared to take risk. In his mind, it’s better to lose “money” than “time”.
When the vaccines were still in research, OWS had poured a lot of money into building factories, complete with the machinery needed, even though all of these will be useless if an effective vaccine isn’t discovered in the end. But that’s what taking risk is.
Pfizer itself didn’t want to get free money from the government. They have a gigantic factory. Maybe just need a few additional facilities. But basically, they have the capability. Their machines can be used to produce several types of drugs at once. So why didn’t Pfizer take the government fund, which for Pfizer alone is up to Rp25 trillion?
“We don’t want our scientists’ freedom to be constrained by bureaucratic rules,” Pfizer’s CEO told US media. But that doesn’t mean the fund won’t flow to Pfizer. Pfizer will still receive the Rp25 trillion allocation, but as money paid to buy their vaccine. Pfizer’s first batch of production in January, estimated to be around 100 million doses, will become the exclusive right of the US Department of Health and Human Services (HHS).
It seems that the production has even started now. In January, the 100 million doses will be delivered. It just needs to wait for FDA authorisation.
In the field of technology and medicine, America can determine its own fate. FDA clearance is enough. It can be distributed immediately. China actually also has its own FDA. Indonesia has BPOM. But these institutions still depend on the WHO, while the FDA regards itself as more powerful than WHO.
This is akin to licensing in the aircraft industry. America has the Federal Aviation Administration (FAA). Even though it belongs to America, in practice it is considered the global leader. As sophisticated as it may be, no one would buy a BJ Habibie-made airplane if it was not certified by the FAA.
Pfizer, having sent a letter to the FDA, felt as if it had been freed from the death row. “This is an important history for mankind,” the company’s spokesperson said.
Of course, someone out there is sulking: Donald Trump. Why hasn’t all this good news come out before the presidential election? What is wrong? Is this a conspiracy? Wasn’t he the one who formed OWS. Wasn’t he the one who put pressure on the FDA to hasten the special permits? Wasn’t he the one who appointed the 60-year-old General Perna? Why was it all late by less than a month?
But let us all be reminded that Trump still has the power to exact revenge. He is still the president until January 20, 2021, 9:00 a.m.
The vaccine will be, of course, free for the American people as it has been purchased with taxpayers’ money. But what if Trump suddenly issues an executive order: only Republicans can get free vaccine!