Pfizer, BioNTech set for billions in yearly sales as fast COVID-19 vaccine launch looms

Pfizer's early COVID-19 vaccine data have spurred intense hope about quashing the pandemic and lifted expectations for other vaccine programs in the works. And for the drug giant specifically, some analysts are predicting billions in sales for the shot for years to come.

In a note to clients Tuesday, SVB Leerink analyst Geoffrey Porges said the results should “boost confidence of the general public in COVID vaccines, which should drive up the early adoption rate.” The analysts see Pfizer’s vaccine snagging all of the early share of the market and generating $258 million in the fourth quarter of 2020.

Next year, though, the analysts see the rollout really taking off. They’re projecting the shot will reel in $4.6 billion in 2021. Though expectations decline to $2.8 billion by 2023, Porges figures the vaccine will still be pulling in $1.2 billion to $1.6 billion in annual sales from 2026 through 2029. 

Early on in the vaccination process, Porges and his team expect the immunizations to be limited to healthcare workers and high-risk adults. Given the strong data, though, they increased their projections for the overall adoption rate for 2021 and 2022 by 4% to 5% and added a small percentage of pediatric vaccinations. 

As for other players in the vaccine race, the SVB Leerink team is largely keeping its market “share assumptions and timing" expectations in place. Pfizer’s vaccine efficacy suggests that there will be “fewer vaccine failures,” the analysts wrote, which “would reduce the addressable markets for COVID treatments.” 

That last statement echoed a stance held by Barclays analysts, who wrote Monday that the Pfizer results “should raise further questions around the mid-to-long-term durability” of revenues from coronavirus therapeutics from companies such as Eli Lilly, Regeneron and Gilead Sciences. Gilead is already generating sizable revenues with Veklury, and Eli Lilly just won an FDA emergency authorization for one of its antibody therapies. 

On vaccines, though, higher usage earlier could ease the pandemic more quickly than previously expected, leading to a lower rate of revaccination down the line, Porges wrote.  

“If most COVID vaccines end up showing efficacy in the 80-90% range, they will likely compete for market share with lower unit price,” Porges wrote. The team’s overall revenue forecasts for the COVID-19 vaccine market start to decrease in 2025.

Pfizer and its partner BioNTech are only advancing one out of many COVID-19 vaccines in the works, but on Monday, they said their leading candidate was more than 90% effective. Questions about the durability of protection, safety, and more remain.

Meanwhile, experts said the results bode well for another frontrunner, Moderna, and numerous other companies that are targeting the spike protein on the coronavirus.

In the wake of the results, Pfizer is expected to seek an emergency use authorization within weeks. The company said it could deliver 50 million doses in 2020 and 1.3 billion in 2021 if given authorization.

https://www.fiercepharma.com/pharma/pfizer-biontech-set-to-earn-billions-amid-fast-covid-19-vaccine-launch-analysts

Pfizer vaccine looks impressive, but Sanofi, J&J, Novavax shots eye logistics edge

Pfizer's COVID-19 vaccine this week set high efficacy expectations, but the vaccine has stringent storage needs and requires two doses, creating significant challenges for a global vaccination campaign. If they prove themselves in the clinic, later-arriving shots from the likes of Sanofi, J&J and Novavax may be better suited for global distribution.

Johnson & Johnson’s vaccine is in testing as a one- and two-dose regimen, for instance, and is expected to be stable at refrigerated temperatures of 35.6 to 46.4 degrees Fahrenheit. When J&J started its phase 3 trial in September, the company said the candidate is "compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.” Now, J&J is performing studies to confirm that expectation, a spokesman said.

Sanofi and GSK’s program, a two-dose recombinant protein vaccine with an adjuvant, can be stored between 35.6 to 46.4 degrees Fahrenheit, or in a doctor’s office or pharmacy, a spokeswoman said. While the partners aren't expected to be the first to deliver doses, execs have said they expect to play an important role in the global immunization push.

AstraZeneca is conducting stability and shipping studies to determine requirements for its vaccine, a spokesman said. The company expects final multi-dose vials "will require refrigeration to ensure product quality, which will involve a reliable, flexible cold chain during transport," he added.

The new class of mRNA vaccines requires colder storage—in Pfizer and partner BioNTech's case, much colder. Pfizer’s vaccine must be kept at minus 94 degrees Fahrenheit (minus 70 degrees Celsius), and will only last for 24 hours at refrigerated temperatures between 35.6 and 46.4 degrees Fahrenheit.

Some countries—and some hospitals in the U.S.—have said they don’t have enough ultracold storage capacity to make a large vaccination campaign feasible, or even possible in some places.  

Sanofi is also advancing an mRNA program with Translate Bio; that shot must be stored at an even colder 112 degrees below zero Fahrenheit. But a spokeswoman said the team is “working on improving the stability of the mRNA vaccine candidate,” and is targeting a storage temperature of minus 4 degrees Fahrenheit.

Moderna’s shot, another late-stage mRNA program, must be stored at minus 4 degrees Fahrenheit. The company expects to post its first efficacy data this month. 

Despite the challenges of its cold-storage needs, Pfizer has an ambitious plan to deliver hundreds of millions of doses in the coming months and into 2021. The company is sidestepping the U.S. federal government’s logistical push, instead opting to set up its own supply chain that uses experienced shipping partners, newly designed storage containers and a fleet of trucks to get doses to vaccination sites. 

Pfizer has supply deals in place with the U.S., Europe, U.K., and Japan. The company expects to produce 50 million doses in 2020 and 1.3 billion doses in 2021.  

But because of the cold chain requirements and logistical challenges of a two-dose regimen, some experts have said the Pfizer program will be mostly for the rich. 

In the U.S., much of the financial responsibility for vaccination campaigns will fall on states, which will need more money from the federal government to make it work, the Chicago Tribune reports.

In places such as India, the vaccine’s storage requirements make a large vaccination campaign unrealistic, according to reports. A Pfizer spokesperson told India's Business Standard the company is looking at ways to make it available there.

Meanwhile, Asian health officials have told Reuters they aren’t holding out hope that the Pfizer shot will be an immediate solution in their countries, and the news service reports that the rollout could also face issues in Latin America and Africa. 

https://www.fiercepharma.com/pharma/despite-pfizer-s-high-efficacy-expectations-other-covid-vaccines-may-have-a-logistics-edge

Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021

Pfizer on Monday revealed stellar early results from its phase 3 COVID-19 vaccine trial, but the news was quickly met with concerns about access as the vaccine comes with hefty cold chain requirements. Pfizer, for its part, already has its sights set on a next-generation formula that could help resolve those storage concerns, the drugmaker's top scientist said. 

The drugmaker is weighing several options for an improved vaccine that could be ready as early as 2021. "For the COVID-19 disease, I think we'll roll out next year a vaccine in powder format," Pfizer's chief scientist, Mikael Dolsten, told Business Insider Monday. 

While Dolsten didn't specify the storage temperature requirements for a powder-form vaccine, the second-generation version "could be just for refrigeration," providing at least "one simplification" over the drugmaker's current version. The first-generation form must be stored frozen at negative 94 degrees Fahrenheit, executives have said.

In its quest to deploy 100 million doses of its vaccine globally by year-end, Pfizer has outlined its own distribution effort focused on sites in Michigan and Belgium, which leverages GPS-monitored shipping containers able to keep shots at the required temperature for 10 days. The company has also queued up additional storage sites in Wisconsin and Germany.

But the costs and logistics of such a plan add up fast and vaccine experts have warned that storage requirements for Pfizer's shot could hinder access in all but the wealthiest of nations. Given the novel mRNA platform behind Pfizer's shot, many countries will face the question of whether to establish previously unneeded deep-freeze production and transportation networks or wait for a vaccine based on an established technology. Other vaccines, such as those from Novavax and Johnson & Johnson, could utilize existing infrastructure. 

"[The shot's] production is costly, its component is unstable, it also requires cold-chain transportation and has a short shelf life," director of the Beijing-based Global Health Drug Discovery Institute, Ding Sheng, told BNN Bloomberg. 

In China, Shanghai Fosun has teamed up with the state-owned Sinopharm to ship Pfizer's shot in cold storage trucks to vaccination sites around the country, where the shots will need to be used within five days, lest they spoil. The effort is likely to cost Fosun tens of millions of yuan, or millions of dollars, according to the company's chairman Wu Yifang. Even then, the odds are high that cold storage requirements will lead to a large portion of those vaccines going to waste, Michael Kinch, a vaccine specialist at Washington University in St. Louis, said. 

This has led some, including Ding at the Global Health Drug Discovery Institute, to question the benefit of overhauling storage infrastructure with a number of other vaccine candidates seemingly around the corner. 

“If there is a protein-based vaccine that could achieve the same effect as an mRNA vaccine does and there’s the need to vaccinate billions of people every year, I’d go for the protein-based shots in the long run."

Meanwhile, developing nations like India are split on how, or whether it's even possible, to fulfill the Pfizer vaccine's frigid shipping requirements. 

The country's current cold chains struggle to keep up with certain regions' need for measles vaccines, which are only required for those below the age of three—"a really trivial number of people compared to the numbers that will need a COVID-19 vaccine," T. Sundararaman, a global coordinator of the public health organization, The People's Health Movement, told BNN. 

Elsewhere, secretary at the country's health ministry, Rajesh Bhushan, said India was in talks with all vaccine developers about potentially securing doses and added that the nation could boost its current cold-chain capacity if need be.

https://www.fiercepharma.com/vaccines/amid-cold-chain-blues-pfizer-looks-to-powder-vaccine-formula-2021-report 

Biden Covid advisor: US 4-6 week lockdown 'could control pandemic, revive economy'

• Dr. Michael Osterholm, a coronavirus advisor to President-elect Joe Biden, said a nationwide lockdown would help bring the virus under control in the U.S.
• He said the government could borrow enough money to pay for a package that would cover lost income for individuals and governments during a shutdown.
• “We could really watch ourselves cruising into the vaccine availability in the first and second quarter of next year while bringing back the economy long before that,” he said. 

• Shutting down businesses and paying people for lost wages for four to six weeks could help keep the coronavirus pandemic in check and get the economy on track until a vaccine is approved and distributed, said Dr. Michael Osterholm, a coronavirus advisor to President-elect Joe Biden.

  Osterholm, who serves as director of the Center of Infectious Disease Research and Policy at the University of Minnesota, said earlier this week that the country is headed toward “Covid hell.” Cases are rising as more people grow tired of wearing masks and social distancing, suffering from so-called “pandemic fatigue,” he said Wednesday. Colder weather is also driving people indoors where the virus can spread more easily.

  A nationwide lockdown would drive the number of new cases and hospitalizations down to manageable levels while the world awaits a vaccine, he told Yahoo Finance on Wednesday.

  “We could pay for a package right now to cover all of the wages, lost wages for individual workers for losses to small companies to medium-sized companies or city, state, county governments. We could do all of that,” he said. “If we did that, then we could lockdown for four-to-six weeks.”

  Osterholm was appointed to Biden’s 12-member Covid “advisory board” on Monday. The panel of advisors is co-chaired by former Surgeon General Vivek Murthy, former Food and Drug Administration Commissioner David Kessler and Dr. Marcella Nunez-Smith of Yale University. Other task force members include Dr. Atul Gawande, a professor of surgery and health policy at Harvard, and Dr. Rick Bright, the vaccine expert and whistleblower who resigned his post with the Trump administration last month.

  A representative for Biden did not return CNBC’s request for comment.

  Osterholm on Wednesday referenced an August op-ed he wrote with Minneapolis Federal Reserve President Neel Kashkari in which the two argued for more restrictive and uniform lockdowns across the nation.

  “The problem with the March-to-May lockdown was that it was not uniformly stringent across the country. For example, Minnesota deemed 78 percent of its workers essential,” they wrote in the New York Times. “To be effective, the lockdown has to be as comprehensive and strict as possible.”

  On Wednesday, Osterholm said such a lockdown would help the country bring the virus under control, “like they did in New Zealand and Australia.” Epidemiologists have repeatedly pointed to New Zealand, Australia and other parts of Asia that have brought the number of daily new cases to under 10 as an example of how to contain the virus.

  “We could really watch ourselves cruising into the vaccine availability in the first and second quarter of next year while bringing back the economy long before that,” he said Wednesday.

  On the current trajectory, Osterholm said the U.S. is headed for dark days before a vaccine becomes available. He said health-care systems across the country are already overwhelmed in places like El Paso, Texas, where local officials have already closed businesses and the federal government is sending resources to handle a surge in deaths caused by Covid-19.

  Osterholm said the country needs leadership. The president-elect is up to the task of providing that leadership, Osterholm said, adding that it could also come from local and state officials or those in the medical community. He referenced the fireside chats broadcast over radio during former President Franklin D. Roosevelt’s terms, through which Roosevelt addressed the country on issues ranging from the Great Depression to World War II.

  “People don’t want to hear that El Paso isn’t an isolated event. El Paso, in many instances, will become the norm,” he said. “I think that the message is how do we get through this. We need FDR moments right now. We need fireside chats. We need somebody to tell America, ‘this is what in the hell is going to happen.’”

  https://www.cnbc.com/2020/11/11/biden-covid-advisor-says-us-lockdown-of-4-to-6-weeks-could-control-pandemic-and-revive-economy.html
  

1st cruise ship to resume sailing in the Caribbean is having a COVID scare

The first cruise vessel to resume sailing in the Caribbean is in the midst of a COVID scare.

A passenger on SeaDream Yacht Club’s SeaDream 1 has tested positive for COVID-19 on a preliminary basis, the captain of the vessel, Torbjorn Lund, announced in a shipwide intercom address shortly after noon on Wednesday.

Lund asked all passengers to return to their cabins, where they would be isolated. Nonessential crew also would isolate immediately, he said.

There are 53 passengers and 66 crew on board the small, yacht-like vessel, which was anchored off Union Island in the Grenadines at the time the announcement was made.

The list of passengers on board SeaDream 1, which just resumed Caribbean sailings on Saturday out of Barbados, includes me. I’ve been on board since Saturday covering this week’s voyage — a watershed moment for the cruise industry.

The sailing was the first in the Caribbean by any cruise vessel since the coronavirus crisis was declared a pandemic in March. The Caribbean is the world’s biggest cruise destination, accounting for at least a third of all cruises taken in a normal year, and the cruise industry has been eyeing a restart in the region for many months.

As I wrote about on Sunday, SeaDream had required passengers to run a gauntlet of COVID-19 testing before boarding SeaDream 1. The idea was to create a COVID-free “bubble” on the ship where the odds that even a single passenger is carrying the new coronavirus on board was extremely low.

Every SeaDream 1 passenger had to test negative for COVID-19 several days in advance of boarding and again on the day of boarding. A third test for all passengers was scheduled to take place today.

Driven in part by the COVID-testing requirements of Barbados, where the vessel is scheduled to spend the winter, this is a far more rigorous testing regime than the world’s biggest cruise lines have mapped out in their plans for a cruising comeback.

SeaDream also is requiring social distancing on board SeaDream 1 and, since Monday evening, mask-wearing. The line did not require mask-wearing during the first two days of the voyage.

During his address to passengers, Lund said the results of the test that came back positive, a rapid test, were “preliminary” but the vessel was working under the assumption that it had one or more COVID patients on board.

He said the passenger who was tested had felt ill before the test.

Lund said the SeaDream 1 would immediately return to Barbados, bringing an end to the current sailing. In a second update a few hours later, he added that the vessel was expected to arrive in Barbados around 10 p.m. Wednesday evening.

In his second announcement, Lund said the ship’s doctor was working through the afternoon testing all the ship’s crew and passengers for COVID-19. The ship is carrying three Abbott ID Now testing machines that each can process one COVID test every 15 minutes.

Lund said Barbadian health authorities would board the ship after it arrived in Barbados late Wednesday, and passengers and crew would likely be tested yet again by the local authorities. He said he wasn’t sure if the additional testing would take place immediately upon arrival or be deferred to Thursday morning.

The initial announcement on Wednesday came just before lunchtime. As passengers were then confined to their cabins, they ate lunch in their rooms. Crew slipped menus under cabin doors that offered a range of options from a cheeseburger to a fillet of Arctic char. Meals were served within a couple hours by mask-wearing staff who did not enter the rooms.

“Please allow a bit of extra time for us to adjust for this new situation,” Lund said during his first announcement. “We are confident in our routines and medical plans, but they are strict, and we apologize for this inconvenience.”

Lund promised regular announcements with updates and said he would send letters with more details to cabins.

In addition to Union Island, SeaDream 1 has visited St. Vincent and the Grenadine islands of Canouan and Tobago Cays during this voyage. But passengers on the vessel have not come in contact with locals on the islands. In order to maintain a COVID-free bubble on board, off-vessel activities have focused exclusively on landings at empty beaches for swimming and sunning, and catamaran trips from the ship for snorkeling.

Passengers have not visited any island towns.

The 53 passengers on board include 37 Americans. There also are passengers from the U.K., Austria, Denmark, Norway, Sweden and Germany.

https://thepointsguy.com/news/caribbean-cruise-covid-scare-seadream/