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Here's What Pfizer And Moderna Say Is Next For Their Covid Vaccines

Pfizer and Moderna say their work on their blockbuster Covid vaccines is far from over, even now that the U.S. Has ended the public health emergency.

The two drugmakers are ushering in a new era for their shots that will elevate the role they play in protecting public health.

The pharmaceutical companies are also trying to simplify what people need to do to coexist with the coronavirus.

© Provided by CNBC A pharmacist prepares to administer COVID-19 vaccine booster shots during an event hosted by the Chicago Department of Public Health at the Southwest Senior Center on September 09, 2022 in Chicago, Illinois.

Three years and billions of Covid vaccinations into the pandemic, Pfizer and Moderna say their work is far from over. 

The two pharmaceutical companies, whose Covid vaccines have become household names, are ushering in a new era for their shots that will elevate the role they play in protecting public health, but also simplify what people need to do to coexist with the virus. 

That involves developing new versions of the vaccines that aim to provide broader and longer-lasting immunity against the virus, and combination jabs that protect against Covid and other respiratory diseases in a single dose, among other efforts.

Those plans coincide with a broader shift in the Covid pandemic landscape.

The U.S. And global-level public health emergencies are over, vaccine uptake and sales growth have slowed, and both Pfizer and Moderna will sell their shots directly to health-care providers at around $110 to $130 per dose as soon as the fall, when the federal stockpile of free vaccines is expected to run out.

Neither company provided CNBC with an update on the exact private market price of their shots.

Many of Pfizer's and Moderna's plans for their vaccines may not reach the public for a few more years, and the success of those efforts isn't guaranteed. 

"One of the greatest things about Moderna is the company's willingness to lean in, even if it's not obvious where exactly things will go," Dr. Jacqueline Miller, Moderna's therapeutic area head of infectious diseases, told CNBC.

Here's what Moderna and Pfizer say is next for their Covid shots.

Annual Covid shots

Pfizer and Moderna aim to keep up with a shift in the U.S. Toward annual Covid shots rather than frequent booster doses. 

Regulators are transitioning toward a flu shot-like model for Covid vaccines, meaning people will get a single shot every year that is updated annually to target the latest variant expected to circulate in the fall and winter. A panel of independent advisors to the FDA will meet in June to select which Covid strain new vaccines should target when they roll out later this year.

Moderna and Pfizer both told CNBC that messenger RNA technology will allow them to keep pace with new Covid variants each year. 

That technology, which is used in Covid shots from both companies, teaches human cells to produce a protein that initiates an immune response against a certain disease. 

Miller, who helped lead the development of Moderna's Covid shot in 2020, said the advantages of using mRNA became evident earlier on in the pandemic. That includes the ability to rapidly scale up the manufacturing of a shot and easily alter the variants they target. 

"The vaccine became proof of the value of mRNA in a pandemic when you need to make something quickly," Miller told CNBC. "The speed of that platform — it allows us to do things three times as fast." 

© Provided by CNBC A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, U.S., on Wednesday, Jan. 26, 2022.

Dr. Mikael Dolsten, Pfizer's chief scientific officer, hopes that annual Covid vaccines will improve public sentiment around getting vaccinated. He said the public grew increasingly dissatisfied with health mandates during the earlier stages of the pandemic, and "unfortunately some people see vaccines as part of that." 

An annual schedule may help people view Covid shots as another "very natural part" of protecting their health and encourage more of them to vaccinate each year, according to Dolsten. 

"I think of it like the introduction of seat belts for cars. People didn't want to wear them at first, but over time they realized how much seat belts protect them. Now everyone uses them today," Dolsten told CNBC. "That's kind of how the vaccine story needs to be reimagined." 

'Next-generation' Covid shots

Pfizer's and Moderna's Covid vaccines both deliver robust protection against the virus, but that immunity can start to fade after four to six months. 

Part of Pfizer's strategy for shifting to an annual Covid vaccine schedule is developing "next-generation" versions of the shot, which aim to broaden and extend the protection people get to a full year. 

"Protection is still there but gradually waning, and we're working with two different approaches to make it a bit more like an annual durability for the majority of people," Dolsten told CNBC.  

Pfizer and its Covid vaccine partner BioNTech are working on a shot that will elevate the level of antibodies a person gets after vaccination by "severalfold," according to Dolsten. 

The vaccine won't work too differently from the company's current shot, which teaches cells how to make harmless copies of Covid's spike protein. The immune system detects that protein and creates protective antibodies that help fend off the virus but decrease over time.

The main difference is that the next-generation shot will teach cells how to make copies of an "enhanced" spike protein, which will generate a far higher level of antibodies that could last for an entire year. 

"If we're elevating antibodies, let's say threefold, that means they will last and protect for a year," Dolsten said. 

The company is working on a second vaccine that aims to boost T-cells, another form of protection that targets and destroys cells infected with Covid. 

In addition to antibodies, Pfizer's existing shot triggers the creation of T-cells against the spike protein. T-cells wane slower than antibodies, meaning they offer longer-term protection against the virus. 

Pfizer is adding another strain of mRNA in its new shot that will broaden that T-cell response. 

The strain will specifically trigger an increase in T-cells against other parts of the coronavirus called non-spike proteins. Those T-cells, in addition to the ones generated against the spike protein, will provide protection against "all corners of Covid's viral landscape," according to Dolsten. 

Non-spike proteins also mutate slower than the spike protein, which means that any T-cells generated against them will likely protect against a wide range of Covid variants. 

© Provided by CNBC Empty vials of Pfizer-BioNTech coronavirus disease (COVID-19) children's vaccines are pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, U.S., May 19, 2022. 

Dr. Paul Burton, Moderna's chief medical officer, said the company has its own "next-generation" Covid vaccine, which aims to improve how shots are stored and administered. 

The company's current shot must be kept in ultra-cold storage. Once thawed, the vaccine can be stored in the refrigerator for up to 30 days, according to Food and Drug Administration guidance.

Burton said Moderna's new shot will be "refrigerator stable," meaning it would have a longer refrigerator shelf life. The company will accomplish that by shortening the length of the mRNA strand in the vaccine, according to Burton. 

The shot could increase the number of vaccine providers around the world, especially in developing countries that may not have freezer capabilities. 

Moderna is studying the shot in a phase 3 trial, Burton said. The company's existing Covid shot is its only commercially available product. 

Combination shots

Pfizer and Moderna are both banking on a new slate of combination vaccines, expected to provide robust protection against Covid and certain respiratory diseases in a single dose. 

Dolsten said there's an increasing need for that kind of shot because certain shifts in society are creating a "more thriving environment" for infections. 

Climate change is driving up the Earth's temperature. Populations are living longer but becoming more vulnerable to disease as they grow older. A growing number of people are moving within countries and across borders. 

Dolsten said those factors have contributed to the spread of different diseases, sometimes at the same time. The U.S., for example, experienced a so-called tripledemic of Covid, respiratory syncytial virus and the flu last winter. 

Dolsten said people may not remember or even feel comfortable taking three different shots for those respiratory diseases on an annual basis. So creating a shot that will help people fight more than one of them at once will "simplify life for them," he said. 

© Provided by CNBC Bottles of vaccine for Influenza Virus, Respiratory Syncytial virus and Covid-19 for vaccination. Flu, RSV and Sars-cov-2 Coronavirus vaccine vials in the medical clinic

Pfizer and BioNTech are developing a vaccine that targets both Covid and the flu. The companies started a phase 1 trial for the shot in November and said they expect to launch it in 2024 or later. 

Dolsten said the drugmakers are also conducting clinical trials for another shot targeting Covid and RSV. Pfizer first hopes to win FDA approval of its RSV vaccine for older adults later this month, he noted. 

Meanwhile, Moderna's shot targeting Covid and the flu is in early clinical trials. Another shot that protects against the flu and RSV is also in that early stage. Moderna is also developing a triple combination shot, which would target Covid, the flu and RSV all at once. 

Burton said Moderna's combination vaccines could be available by 2025 at the earliest, noting that the company still needs the FDA to approve its individual flu and RSV shots.

The public health benefit of combination vaccines will be "tremendous globally" since Covid, RSV and the flu can be deadly, according to Burton. He added that the convenience of those shots could encourage more people to take it. 

"To have to get three different shots for each and go to a pharmacy chain a couple of times, it can be burdensome for people," Burton told CNBC. "So to be able to get a single 3-in-1 or 2-in-1 shot – we know that compliance and adherence are huge with a single administration."

Moderna Rakes In Surprise Profits Ahead Of 400% Vaccine Price Hike

Enlarge / Moderna CEO Stephane Bancel during a Bloomberg Television interview on the closing day of the World Economic Forum in Davos, Switzerland, on May 26, 2022. GettyJason Alden reader comments 90 with

Things are looking rosy for Moderna, as it reported unexpected first-quarter profits Thursday. But the company is not wavering in its plans to dramatically hike the price of its COVID-19 vaccines.

Further Reading Moderna CEO brazenly defends 400% COVID shot price hike, downplays NIH's role While financial analysts expected the company to post revenue of $1.18 billion and a loss of $1.77 per share in the first quarter, the company reported $1.86 billion in revenue with a small profit of 19 cents per share.

The company forecasts $5 billion in COVID vaccine sales for this year.

The plump profits haven't changed the company's plans for its COVID-19 vaccines. In an earnings call Thursday, Moderna Chief Commercial Officer Arpa Garay confirmed that the company is still proceeding with the 400 percent increase as the vaccines move from federal distribution to the commercial market later this year.

"In terms of pricing across the US market, we do anticipate our list price—when we have our updated vaccines—to be in the range of $110 to $130," Garay said.

In March, Moderna CEO Stéphane Bancel unabashedly defended the price hike to lawmakers in the face of biting criticism. Senators in the Congressional hearing emphasized that Moderna developed the vaccine in collaboration with government scientists at the National Institutes of Health, and the federal government spent roughly $10 billion to support clinical development and speed production of the shots in the early days of the pandemic.

Advertisement Further Reading Moderna CEO says private investors funded COVID vaccine—not billions from gov't "This vaccine would not exist without NIH's partnership and expertise and the substantial investment of the taxpayers of this country," Sen. Bernie Sanders (I-Vt.), who led the hearing, said. "And here is the thank you that the taxpayers of this country received from Moderna for that huge investment: They are thanking the taxpayers of the United States by proposing to quadruple the price of the COVID vaccine."

According to a report from The Washington Post last week, Bancel has profited handsomely from the pandemic, which made him a billionaire. Last year, Moderna increased Bancel's salary by 50 percent to $1.5 million and increased his target cash bonus. He also exercised stock options worth nearly $393 million.

Moderna's pay and governance, in general, has raised eyebrows among financial analysts, the Post notes. Moderna board members' pay ranks in the top 25 percent of directors at America's top 500 largest publicly traded companies, with a member's average pay last year set at $475,000. That's well above rival pharmaceutical giants, including Pfizer, Bristol-Myers Squibb, and Merck.

Harvard Professor Wrongly Belittles MRNA Covid Vaccine R&D In Congressional Testimony

In the midst of the Covid-19 pandemic, when thousands of people were dying on a daily basis, the hopes of the world rested on the biopharmaceutical industry for rapidly finding vaccines, antibodies and therapeutants. Nowhere else could such work be done. In record time, this industry delivered on all fronts, especially with vaccines from Moderna and Pfizer/BioNTech. The impact of these breakthroughs cannot be overstated. It has been estimated that, thanks to the availability of Covid-19 vaccines in the U.S., from November 2020 until March 2022, 2,265,222 deaths were averted, 17,003,960 fewer hospitalizations occurred, and 66,159,093 Covid-19 infections were avoided – all leading to $899.4 BILLION in healthcare costs averted.

(Photo by Craig F. Walker/The Boston Globe via Getty Images)

Boston Globe via Getty Images

Thanks to the availability of these vaccines, the reputation of the biopharmaceutical industry rose dramatically to levels not seen since the industry's heyday in the 1990s. This wasn't surprising. Thanks to the extraordinary efforts of these companies, the U.S. Began to climb out of the abyss of lockdowns, school shutdowns and business closures. People were grateful – and appreciative.

However, this era of good feeling hasn't lasted. We are now past the pandemic and people are focused on other issues in the drug industry. Perhaps that was to be expected. However, what was not expected was the rewriting of history with respect to the achievements made in getting us beyond the pandemic. Typical is the testimony given last week by Harvard medical professor Dr. Aaron Kesselheim to the health subcommittee of the House Ways and Means Committee. Dr. Kesselheim, who has no experience in the biopharmaceutical industry, shared his views about "meaningful medical innovation". His thoughts about the Covid-19 vaccines are particularly stunning. Kesselheim highlighted that the U.S. Government made available $32 billion to speed up development and production of the vaccine candidates in addition to buying doses of the vaccines and in doing so "almost completely derisked the investment for manufacturers."

This statement would be laughable if it wasn't so dangerously wrong. In the early stages of the pandemic, the government set up "Operation Warp Speed" (OWS) to help facilitate the development of viable Covid-19 vaccines. OWS selected six companies that it thought had the best chances of success and set aside funds to help in vaccine development. Moderna and Pfizer were two of these companies. However, it must be remembered that, in February 2020, mRNA technology was unproven. In fact, there were those who had little hope of success for this novel approach to vaccine discovery. After all, Moderna, whose entire company was based on this technology, had been in existence for a decade with no products to show for it. When Pfizer announced its deal with BioNTech to discover and develop a Covid-19 vaccine, CEO Albert Bourla famously said it would put at risk $1 billion to fund this effort and that "this investment wouldn't break us". Actually, Pfizer had to spend $2 billion and I contend that, had this investment in an unproven technology failed, the Pfizer board of directors would have had a lot of questions for Dr. Bourla.

Fortunately, both Pfizer and Moderna were successful. Because it had no revenues, Moderna needed more than $1 billion in OWS funding to build manufacturing capacity. Pfizer took NO MONEY. OWS did agree to buy vaccines should any of the original six companies deliver a vaccine that was proven both safe and effective as deemed by the CDC and FDA.

Now, let's examine Dr. Kesselheim's trivialization of this achievement. At the start of the pandemic, mRNA vaccines were a pipe dream. There was no guarantee that this technology would be successful. Yes, OWS provided fund to help manufacture the Moderna vaccine – it would have been foolish to let this vaccine sit on the shelf and not be mass produced because of a lack of manufacturing capacity. And of course the government would purchase any viable vaccine once approved – it was battling a deadly pandemic. It is notable that when Pfizer announced its terrific vaccine efficacy, it was inundated by nations around the world with requests to purchase the vaccine for their respective countries. Thanks to the financial commitment made by OWS, the U.S. Was first in line.

Dr. Kesselheim, as a supposed expert on meaningful drug innovation, belittled what many believe is the most important medical innovation in our lifetime. He has no appreciation of the challenges inherent in biopharmaceutical R&D. Yet, when he goes before Congress and testifies so cavalierly, it trivializes the work of thousands of researchers – researchers who strive daily to come up with the next major breakthrough. At a time when there is so much that can be done to improve the world's health, this industry needs support. Unfortunately, Dr. Kesselheim doesn't get that.

(John L. LaMattina is the former president of Pfizer Global R&D. He is the author of Pharma and Profits – Balancing Innovation, Medicine, and Drug Prices.)

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