Move Over, Moderna: Why Pfizer May Be The Better Bet To Deliver A Vaccine By Fall – Forbes

The inside story behind the pandemic, the CEO and a promising, unproven treatment.

In the middle of March, Pfizer chief Albert Bourla beamed into a WebEx video call with the leaders of the American pharmaceutical giants vaccine research and manufacturing groups.The two teams had worked late into the night on a robust development plan for Pfizers experimental Covid-19 vaccine and told Bourla that they aimed to make it available lightning-fast. It could be ready sometime in 2021.

Not good enough, Bourla said. The faces of the researchers tensed up, and conscious of the Herculean effort that had taken place, Bourla made sure to thank them. But he also kept pushing. He asked if people on the call thought the virus might come back in the fall, and what they expected would happen if a vaccine were not available when a new flu season hit at the same time, an issue the federal Centers for Disease Control raised weeks later.

Think in different terms, Bourla told them. Think you have an open checkbook, you dont need to worry about such things. Think that we will do things in parallel, not sequential. Think you need to build manufacturing of a vaccine before you know whats working. If it doesnt, let me worry about it and we will write it off and throw it out.

Says Mikael Dolsten, Pfizers chief scientific officer: He challenged the team to aim for a moon shotlike goalto have millions of doses of vaccine in the hands of vulnerable populations before the end of the year.

On the first Monday of May, Pfizer dosed the initial batch of healthy American volunteers in Baltimore with an experimental Covid-19 vaccine it developed with Germanys Bio-NTech. Bourla was informed immediately. The following day, in an interview from his home in suburban Scarsdale, New York, he pointed out that it normally takes years to accomplish what Pfizer had just done in weeks. How fast we moved is not something you could expect from the big, powerful pharma, he said. This is speed that you would envy in an entrepreneurial founder-based biotech.

A Greek veterinarian who worked his way up the Pfizer corporate ladder for 25 years before becoming CEO in 2019, Bourla says nothing in his career could have prepared him for this moment. But he does believe the massive corporate transformation he has ledsteering a behemoth conglomerate (2019 sales: $51.8 billion) deeper into the high-risk, high-reward game of developing new patented medicines and away from generic drugs and consumer products like Advil and Chapstickhas prepared Pfizer.

Shot of Hope. Volunteers receive injections of Pfizers experimental Covid-19 vaccine in early May at the University of Maryland School of Medicine in Baltimore.

For Bourla, 58, the last four months have been a rollercoaster, an unending series of setbacks and victories. Pfizer is not alone in the race. Most of the worlds biggest pharmaceutical companies, including Johnson & Johnson, Sanofi, AstraZeneca and Roche, are throwing everything they can at Covid-19.

Some experts feel Bourlas timelinea viable vaccine in a matter of a few monthsis simply unrealistic. Undeterred, Bourla has tasked hundreds of researchers to scour Pfizers trove of experimental and existing medicines to look for potential therapies. Early on, he openly authorized having discussions and sharing proprietary information with rival firms, moves unheard of in the secretive world of big pharma. Bourla has made Pfizers manufacturing capabilities available to small biotech concerns and is in talks as well to make large quantities of other companies Covid-19 drug candidates.

Pfizers most prominent effort is its work with Mainz, Germanybased BioNTech, an innovative $120 million (2019 sales) outfit that is mostly known for making cancer medications. The resulting experimental Covid-19 vaccine works with messenger RNA, a bleeding-edge technology that has never resulted in a successful treatment. Pfizer is hoping to get emergency-use authorization from the U.S. government for the vaccine by October. Its unique strategy is to rapidly pit four different mRNA vaccine candidates against one another and double down on the most likely winner.

In preparation, the company is shifting production at four manufacturing plants to make 20 million vaccine doses by the end of the year and hundreds of millions more in 2021. Bourla says Pfizer is willing to spend $1 billion in 2020 to develop and manufacture the vaccine before they know if it will work: Speed is of paramount importance.

While the vaccine effort is getting most of the publics attention, Pfizer is also rushing to start a clinical trial this summer for a new antiviral drug to treat Covid-19. Additionally, its involved in a human study that seeks to repurpose Pfizers big arthritis drug, Xeljanz, for later-stage Covid-19 patients.

Being the CEO of a pharma company that can make a difference or not in a crisis like this is a very heavy weight, Bourla says. Even the way my daughter or son ask me, Do you have something or not? Every person who knows me does the same. You feel if you get it right, you can save the world. And if you dont get it right, you will not.

In January, Uur ahin, the brilliant immunologist who founded BioNTech, read an article about Covid-19 in The Lancet. ahin built BioNTech to hack human cells to go after diseases, particularly cancer, and he thought similar tech might work against the coronavirus. Soon after, ahin spoke to Thomas Strngmann, the German pharma billionaire who for years has backed ahin and his wife, immunologist zlem Treci, in their ventures. He said, This is a big disaster. He said the schools will be closed, that this will be a pandemic, Strngmann says, referring to ahin. He switched most of his team to the vaccine.

A New Reality. Pfizer CEO Albert Bourla under lockdown in his suburban New York home, from which he has directed his troops to make the impossible possible.

In February, ahin (who is also now a billionaire, as BioNTechs stock has soared) called up Kathrin Jansen, who heads vaccine research and development for Pfizer. ahin told Jansen BioNTech had come up with vaccine candidates for Covid-19 and asked if Pfizer would be interested in working with him. Uur, you are asking? Jansen replied. Of course we are interested.

Over the last few years, scientists have become intrigued by the idea of using messenger RNA, the genetic molecule that gives cells protein-making instructions, to develop medicines for cancer, heart disease and even infectious viruses by transforming human cells into drug factories. Because SARS-CoV-2, as the coronavirus is formally known, is an RNA virus, researchers like ahin focused on the idea of giving mRNA the cellular machinery to make proteins that would create virus-protecting antibodies.

An mRNA vaccine has huge advantages over a traditional one. Because it can be made directly from the genetic code of the virus, it can be invented and entered into clinical trials in a matter of weeks, rather than months or years. But theres a big downside: No one has ever successfully made one.

BioNTech is not alone in pursuing an mRNA vaccine. Moderna Therapeutics, a biotech in Cambridge, Massachusetts, also got going in January and has launched a big human trial for its mRNA vaccine, backed by $483 million from the federal government. Moderna is likewise aiming to produce millions of doses per month by the end of the year.

Pfizer was already comfortable with BioNTech. Two years ago, the two companies inked a $425 million deal to develop an mRNA flu vaccine. Pfizer was intrigued by the potential of an mRNA approach to short-circuit the process of developing a vaccine for a new strain of the flu every year. That same flexibility and speed appealed to Bourla when it came to working with a partner on a potential vaccine for Covid-19.

On March 16, Bourla convened Pfizers top executives and informed them that return on investment would not play a role in the companys Covid-19 work. This is not business as usual, Bourla told them. Financial returns should not drive any decisions.

A billion dollars is not going to break us. And I dont plan to lose it. I plan to make sure we use this product.

Pfizer signed a letter of intent with BioNTech the next day. The contract they finalized in April makes no mention of commercialization. Pfizer is bringing its enormous manufacturing, regulatory and research capabilities to the effort. BioNTech is bringing the basic science.

At the same time, Bourla made the decision to spend $1 billion on the project, so if the vaccine works, it can be made available this autumn. Pfizer will also be on the hook to pay BioNTech an additional $563 million if everything goes according to plan. A billion dollars is not going to break us. And, by the way, I dont plan to lose it. I plan to make sure we use this product, Bourla says. You never know until you see the data. So yes, we are going to lose a billion if the vaccine doesnt work.

What makes Pfizers approach unique is that its testing four distinctive vaccinesdifferent mRNA platforms that are supposed to induce a safe immune response. The complex trial will start by testing different dosing levels of the four vaccines in 360 U.S. volunteers and 200 in Germany, eventually expanding to around 8,000 participants.

The U.S. trial was designed to evolve so the company could quickly stop testing any one of the vaccines if immunogenicity data show it is not producing enough antibodies to confer virus protection. The companies are making adjustments on the fly. BioNTech recently realized one of the vaccine candidates should be dosed at a lower level to be safean early fling of a monkey wrench into the plans.

There is considerable skepticism among experts that Pfizers goal of providing millions of doses to vulnerable populations by the fall is possible. Drew Weissmann, whose University of Pennsylvania laboratory has worked with BioNTech on mRNA vaccines for infectious diseases, recently told Forbes it is simply not known if an mRNA vaccine can prevent infectious disease.

First Time. Uur ahin, the Turkish-born CEO of BioNTech. The German outfit was founded 12 years ago, but despite considerable promise it has yet to bring an approved drug to market.

Jansen, Pfizers vaccine research chief, expects that Pfizer and BioNTech will have a better idea around the beginning of July as to which of the four vaccine candidates is the most promising and whether their hyper-accelerated timeframe is feasible. The company will likely move just one or two of the most promising vaccines to more advanced trials.

Its not easy. As a matter of fact, it has never been done beforeI cant give you a probability, Jansen says. An unprecedented crisis, such as the ongoing pandemic, requires unprecedented action. Albert was the first to see that and act on it, and to provide the support and the environment for us to think and act boldly.

W

hen Albert Bourla started his run at the top of Pfizer in January 2019, he removed the bulky brown table from the CEOs conference room and did not replace it, re-arranged the chairs in a circle and put up photographs of patients on the wall. The idea was to promote open discussion and remind people about the real purpose of a pharmaceutical company. Soon after, other Pfizer employees began to put pictures on their desks of patients they know or love.

The unorthodox way Bourla took to the pinnacle of corporate power started in Greeces second-biggest city, Thessaloniki, a northern port city on the Aegean Sea. He grew up middle-classhis father and uncle owned a liquor storeas part of a tiny Jewish minority that survived the German occupation and the Holocaust.

A love of animals and science drove Bourla to become a veterinarian. At Thessalonikis Aristotle University, he was known for playing the guitar and singing, and during the summers worked as a European tour guide. He joined Pfizers Greece office in 1993, working in its animal-health division, beginning an ascent that saw him move his family to eight cities in five countries, including Poland and Belgium.

By 2014, Bourla was a high-level executive at Pfizers Manhattan headquarters on 42nd Street, where, among other things, he ran Pfizers vaccine and cancer divisions. He brought a Mediterranean flair to the buttoned-up conglomerate. His group meetings were boisterous, echoing through the otherwise largely silent corridors. He forced company units to express their metrics in terms of how many patients they were helping, not merely in terms of dollars and cents.

Making It. Pfizer is stockpiling inventory of its existing vaccines and injectable drugs to free up manufacturing capacity to make a Covid-19 vaccine later this year.

Ian Read, Pfizers Scottish-born CEO at the time, had reversed the companys fortunes on Wall Street, where its stock had been badly underperforming, by repurchasing lots of shares and divesting businesses that sold baby formula and animal medicines. Less visibly, Read reinvigorated Pfizers drug pipeline in its core vaccine business and empowered Pfizers researchers to develop targeted therapies, particularly for cancer, as some of its mass-marketed drugs, like the cholesterol-lowering blockbuster Lipitor, went off-patent.

Bourlas last job before ascending to the C-suite was as head of Pfizers innovation group. He approached the position as though he was running a life-sciences venture capital firm. He forced each of his six business units, which included oncology, vaccines and rare diseases, to compete for financing. I was telling all of them, Im your boss, I am private equity, the one who has the better ideas will get the money, he says. A company that has the scale of Pfizer and the mindset of a small biotech was always my dream.

Albert has a sense of urgency, and that is coming out in the way he is marshaling the companys resources behind trying to develop a vaccine or treatment for Covid-19, says Read, his former boss. He is a charismatic people person, energizing groups of people to get the job done.

Bourlas urgency was evident after a difficult weekend in February when he realized that Covid-19 was not going to be just a problem for China. On a call the following Monday morning, Bourla fired off instructions to Pfizers top brass. He told the science executives to make sure the companys labs remained open, and that Pfizer needed to contribute to a medical solution to the pandemic. If not us, then who? Bourla said. He instructed the manufacturing group to make a list of Pfizers drugsincluding those that treat heart failure and opportunistic bacterial infectionsthat would be in high demand in a pandemic and make sure they wouldnt be hampered by production bottlenecks. He then officially informed the board that he was pivoting the company toward Covid-19.

The better ideas will get the money. A company with the scale of Pfizer and the mindset of a small Biotech was always my dream.

One day in the midst of this retooling, Pfizer director Scott Gottlieb, who used run the FDA, left the companys Manhattan headquarters, and within hours his fears were coming to pass: Reports were emerging from California indicating community spread in America. That evening Gottlieb posted a Twitter thread: A long fight could be ahead, one requiring shared sacrifice, he saidbut partly because of Bourlas efforts at Pfizer, he could also say that development of vaccines and therapeutics was already underway.

Albert laid out early why it was so important to put up the enormous resources of Pfizer without an eye toward the business bottom line, Gottlieb says. Coming up with a vaccine could change the course of human history. That is literally whats at stake, and big companies have the ability to scale up manufacturing and run big trials in a way not available to small product developers.

In the middle of March, Bourla decided to publicly release Pfizers plan to share data from its Covid-19 research with rival pharmaceutical companies. He promised to use any excess manufacturing capacity and even shift production at Pfizers facilities away from its own products to make Covid-19 treatments from other companies. You know the saying, Bourla says. Beware [of] what you wish for.

Since then, Pfizer has heard from 340 companies. It has already given technical support to some of them and is on the brink of signing large manufacturing agreements with others. It is also in discussions with additional firms that need financing for their own Covid-19 therapies.

Will my kids go to school next fall? Bourla wonders. Im also part of society. You cannot stay silent.

Quick Kill. Thats how Kathrin Jansen, Pfizers vaccine-research chief, describes its approach to its four vaccine candidates: Terminate any vaccine thats not showing it can produce sufficient neutralizing antibodies.

At a video meeting of Pfizers board of directors in late April, Bourla was asked what would happen if multiple vaccine makers were successful. That would be the best possible outcome, he replied, because enormous amounts of vaccine could be quickly produced.

Beyond the holy grail of a vaccine, Pfizer is also trying to come up with therapeutic solutions. The researchers tasked with combing through Pfizers molecular database became intrigued by several of its antiviral compounds that might attack the virus by stopping it from reproducing. After Pfi-zer got the DNA sequence of the coronavirus in January, researchers figured out which could work best.

Conducting preclinical work on the selected compounds, however, was difficult. Pfizer had trouble finding a lab that could perform the proper assays. The company had scaled down its antiviral research a decade ago and no longer owned a suitable biosafety lab to work with the live virus. At one point, Bourla feared the lack of a lab would delay the clinical-trial process. But a separate government medical agency helped Pfizer find a good one in the Netherlands.

There have been multiple moments of bad news coming to spoil the good news you had three hours earlier, Bourla says. Pfizers laboratory work has since shown one of its protease inhibitors, initially developed to battle SARS, to exhibit antiviral activity against SARS-CoV-2. Pfizer is now aiming to start a human trial for that antiviral, which is administered intravenously, by the end of the summer.

Another Pfizer drug getting attention is Xeljanz, a rheumatoid arthritis pill generating $2.2 billion annually. It is seen as a potential way to tamp down the massive immune response to Covid-19 that overwhelms some infected patients. Pfizer is supporting a Xeljanz trial in Italian Covid-19 patients, as well as another U.S. trial that will test a different arthritis medicine, an experimental drug that targets the Irak-4 protein, against the virus.

While all this is going on, of course, Bourla still needs to run the rest of Pfizer. He recently planned a symbolic visit to a Pfizer plantnone has closedbut after making the arrangements, he was informed that he would not be allowed to enter because he was not deemed essential.

I dont know if I was ever prepared for something like this, Bourla says. But you feel that you need to suck it up and rise to the occasion because thats what you have to do.

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Move Over, Moderna: Why Pfizer May Be The Better Bet To Deliver A Vaccine By Fall - Forbes