Progressives up pressure on Biden to back COVID vaccine patent waiver

Progressives are increasing pressure on President Biden to support a waiver for COVID-19 vaccine patent protections at the World Trade Organization (WTO), arguing the move is crucial for helping lower-income countries fight the coronavirus.

The push features leading Democratic lawmakers and advocacy groups calling on Biden to take action, but the White House has not made clear its position.

“The Biden administration has an obligation to reverse the damage done by the Trump administration and reestablish our nation’s global reputation as a public health leader,” said Rep. Rosa DeLauro (D-Conn.), head of the powerful House Appropriations Committee.

Sen. Bernie Sanders (I-Vt.), who chairs the Senate Budget Committee, released a video calling on Biden to support the proposal.

“We need a people’s vaccine, not a profit vaccine,” Sanders says in the video.

The effort is fiercely opposed by the pharmaceutical industry, including key vaccine makers like Pfizer, Johnson & Johnson and AstraZeneca.

At issue is a proposal before the WTO, led by India and South Africa and backed by more than 50 other countries, to waive intellectual property protections for COVID-19 vaccines. Proponents argue it would enable lower-income countries to ramp up their own manufacturing and help address severe shortages outside of the richest countries and benefit every country by cutting down on the ability of new variants to develop as the virus spreads.

Opponents argue patent protections are needed to incentivize innovations, like the record turnaround time in developing COVID-19 vaccines. More broadly, they say the waiver wouldn’t solve existing problems given that vaccines are complex to make and there are already voluntary efforts to take advantage of manufacturing capacity in other countries, without resorting to stripping patents.

A spokesman for the U.S. trade representative said the administration is “exploring every avenue to coordinate with our global partners and are evaluating the efficacy of this specific proposal by its true potential to save lives.”

But the Biden administration is facing pressure from some of its major allies, making the push hard to ignore.

In the House, DeLauro is leading the effort along with Democratic Reps. Jan Schakowsky (Ill.), Earl Blumenauer (Ore.) and Lloyd Doggett (Texas).

They are working on a letter to the administration in support of the waiver, with more than 60 lawmakers signing on so far.

Speaker Nancy Pelosi (D-Calif.) has also privately expressed support for the waiver, Schakowsky said.

“I don’t usually speak for the Speaker, that’s for sure, but she has said so many times now that she has talked to the administration and she is fully in support of this waiver,” Schakowsky said during a press conference at the end of February. “There are so many voices now getting to the president that I still feel optimistic that the right thing can be done by the United States.”

Pelosi’s office declined to comment.

The effort is also backed by a wide array of outside groups, including Oxfam, Doctors Without Borders and Partners in Health.

Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, also backed the idea in a Guardian op-ed this month.

Of the 225m vaccine doses that have been administered so far, the vast majority have been in a handful of rich and vaccine-producing countries, while most low- and middle-income countries watch and wait,” he wrote.

Experts say Americans are at danger, too, if the virus continues to spread in other parts of the world, given that  new, dangerous variants can develop.

“Mindful of COVID variants from Brazil and South Africa, to stop this deadly virus, we need widespread immunization everywhere around the globe, not just in the wealthiest countries,” Doggett said.

Others, however, argue that while the waiver effort may be well-intentioned, it would not be effective.

“Because of the technical complexity of manufacturing coronavirus vaccines, waiving intellectual-property rights, by itself, would have little effect,” Rachel Silverman, a policy fellow at the Center for Global Development, wrote in a Washington Post op-ed last week. “It could even backfire, with companies using the move as an excuse to disengage from global access efforts.”

The Pharmaceutical Research and Manufacturers of America wrote a letter to Biden this month opposing the waiver, arguing it “would not speed up production” of vaccines.

“Intellectual property is the foundation for both the development and sharing of new technologies,” the group wrote. “Perhaps more than any other time in history, society is seeing and benefiting from the innovation supported by intellectual property.”

Instead, the industry points to voluntary licensing agreements that companies have entered into to share vaccines, such as AstraZeneca partnering with the Serum Institute of India to produce 1 billion vaccine doses for low- and middle-income countries.

The Biden administration has highlighted steps already taken by the U.S. to increase global vaccine access, like funding for Covax, the World Health Organization’s vaccine initiative, and an agreement announced with “Quad” countries — the U.S., Australia, Japan and India — to provide funding to help produce 1 billion vaccine doses.

While emphasizing those efforts, Adam Hodge, a U.S trade representative spokesman, also left the door open to supporting the waiver.

“The top priority of the United States is saving lives and ending the pandemic in the United States and around the world,” he said. “This includes investing in COVAX and working with partners, as we announced with the Quad, to surge vaccine production and delivery.  As part of rebuilding our alliances, we are exploring every avenue to coordinate with our global partners and are evaluating the efficacy of this specific proposal by its true potential to save lives.”

The administration is engaged in “detailed technical discussions about the merits of the proposal” with both developed and developing countries, an administration official said.

The members of Congress pushing for the waiver say they have not received a clear response from the White House. Part of the issue is that U.S. Trade Representative Katherine Tai was only confirmed last week.

“We have not gotten like a flat no,” Schakowsky said in an interview. But, she added, “we have not seen any movement.”

Blumenauer said he plans to speak with Tai about the issue.

I think they’re being cautious,” he said. “There are lots of moving pieces and they need cooperation with the industry, with the various companies.”

But backers say they’re not giving up.

“We’re going to keep at it and keep at it and keep at it,” DeLauro said.

Taken From: https://thehill.com/policy/healthcare/544620-progressives-up-pressure-on-biden-to-back-covid-vaccine-patent-waiver

DRUGMAKERS PROMISE INVESTORS THEY’LL SOON HIKE COVID-19 VACCINE PRICES

Pfizer, Moderna, and Johnson & Johnson pledged affordable vaccines — but only as long as there’s a “pandemic.

THE U.S. PHARMACEUTICAL FIRMS behind the approved coronavirus vaccines — Johnson & Johnson, Moderna, and Pfizer — have quietly touted plans to raise prices on coronavirus vaccines in the near future and to capitalize on the virus’s lasting presence.

While the companies have enjoyed a boost in goodwill from the rush to develop vaccines, drug industry executives have noted, the public is still sensitive to drug pricing and the reputational risk has, so far, curtailed their ability to reap large financial rewards.

But that environment, they hope, will change once the pandemic ends: a date that drugmakers themselves reserve the right to declare. Pharmaceutical officials, speaking at recent conferences and on calls with investors, say they expect the virus will linger, morphing from a pandemic into a perennial endemic. And as Covid-19 mutations continue to spread and booster shots may be required on a regular basis, leaders from the three companies are enthusiastic about cashing in.

“As this shifts from pandemic to endemic, we think there’s an opportunity here for us,” said Frank D’Amelio, the chief financial officer for Pfizer, at a conference. Additional factors, such as the need for booster shots, present “a significant opportunity for our vaccine from a demand perspective, from a pricing perspective, given the clinical profile of our vaccine.”

Moderna and Johnson & Johnson have also pledged affordability for their vaccines for the duration of the pandemic but have indicated to investors that they plan to return to more “commercial” pricing as early as later this year.

The vaccines are already poised to be some of the most lucrative drugs of all time. The companies are expecting to bring in billions in profit this year alone, and all the major drugmakers with approved coronavirus vaccines received investments and backorders from government agencies.

The U.S. government has fully financed the research and development of several coronavirus vaccines, including those produced by Moderna and Johnson & Johnson, to the tune of over $2 billion. The U.S. has also provided nearly $2 billion in payments to secure doses of Pfizer’s vaccine, which was developed in partnership with BioNTech, a company that received nearly $500 million in development assistance from the German government.

PFIZER, one of the early global leaders in the vaccine race, is very clear about the enormous moneymaking opportunity they see in the vaccines. D’Amelio, the company’s CFO, spoke on a Zoom call last Thursday at the Barclays Global Healthcare Conference, to discuss the issue.

Carter Lewis Gould, an analyst with Barclays Bank, noted that Pfizer faced the particular challenges with “optics” but asked when the company could “pursue higher pricing down the road.”

The current pricing, said D’Amelio, is “clearly not being driven by what I’ll call normal market conditions, normal market forces,” but rather the “pandemic state that we’ve been in and the needs of governments to really secure doses from the various vaccine suppliers.” Once the pandemic ends, he continued, there will be “significant opportunity” for Pfizer.

The comments build on a lengthy explanation of the financials of the vaccine laid out during Pfizer’s last quarterly earnings call. During the event, Pfizer executives announced that the company’s coronavirus vaccine was projected to bring in $15 billion this year alone from sales, of which $4 billion would be purely profit. The estimate would make the Pfizer coronavirus vaccine, according to observers, one of the highest-grossing pharmaceutical products of all time.

Those revenue projections are based on prices largely negotiated with governments under pandemic conditions, which could soon change. Pfizer, in its latest investor disclosures, revealed that it received advance payments for its vaccine totaling $957 million as of December 31. In the U.S., the company has agreed to a price of $19.50 per vaccine dose or $39 per patient based on a two-dose series. In the European Union, the company charges a higher rate, nearly $64 per dose. These figures, however, could increase. Pfizer’s pneumococcal vaccine, Prevnar 13, for instance, costs $200 per dose on the private market.

The company has faced calls for new price controls and to release the vaccine as a generic. Sen. Bernie Sanders, I-Vt., has demanded that Pfizer and other drugmakers share patents and intellectual property associated with the vaccine with the developing world in order to end the pandemic as fast as possible. The industry, through its vast network of lobbyists, has fiercely opposed the proposal, as well as similar calls for price regulations.

Pfizer Chief Executive Officer Albert Bourla, during the investor call, said the company had little to worry about in terms of political opposition.

“We believe the industry has generated a great deal of goodwill with Congress and public opinion through our Covid-19 treatment and vaccine efforts,” said Bourla. He added that he looked forward to working with the Biden administration and members of Congress from both sides of the aisle.

LAST YEAR, many pharmaceutical companies pledged to temporarily suspend many ordinary pricing strategies in order to help end the coronavirus crisis. Moderna made waves last October when the company announced that it would not enforce certain patent rights for its vaccine. AstraZeneca, whose vaccine has been approved abroad but not yet in the U.S., promised last year to only sell its vaccine on a nonprofit basis to the developing world “during the pandemic.”

But these promises have fallen short. Pfizer has reportedly pressed Latin American governments, including Argentina, to put up sovereign assets, such as embassy buildings and military bases, as collateral to cover the costs of lawsuits related to adverse effects of the vaccine.

AstraZeneca’s promises have been undercut by leaked agreements. In its deals with local manufacturers, AstraZeneca has stated that the company reserved the right to declare the end of the pandemic for pricing purposes. The Financial Times obtained a memorandum of understanding revealing that its promise not to profit from the vaccine during the pandemic would end as soon as July 1, 2021.

Moderna has not taken any steps to share vaccine intellectual property rights, manufacturing technology, or design and has declined to participate in the World Health Organization-backed fund to distribute low-priced vaccines to the developing world.

Moderna President Stephen Hoge, speaking at the Barclays Bank conference last week, similarly made clear that his company would remain sensitive to pricing concerns around affordability during the pandemic.

“Post-pandemic, as we get into those what I will call seasonal epidemics that you would expect to happen with a SARS-CoV-2 virus, we would expect more normal pricing based on value,” said Hoge

Joseph Wolk, the executive vice president of Johnson & Johnson, speaking at the Raymond James Institutional Investors Conference this month, noted that investors could expect the company to reevaluate the vaccine for “pricing that’s much more in line with a commercial opportunity” when the pandemic is over.

Wolk noted that the end of the pandemic is a “fluid” question. The announcement, Wolk said, would come down to a percentage of people vaccinated, though he did not give any specific figures. The “pandemic period will be in place for the majority of this year, if not the entire piece of this year,” he continued, before making it clear that the declaration would be left to Johnson & Johnson.

“I think when we look at it, it’s not going to be something that’s dictated to us,” said Wolk.

The end of the pandemic may be declared by the World Health Organization or other international bodies. Drug firms, however, are not under a legal requirement to make prices based on the WHO’s determination.

Moderna and Johnson & Johnson did not respond to requests for comment regarding its pricing strategies and under what circumstances the firms would use to determine an end to the pandemic.

Asked for comment on when Pfizer would declare an end to the pandemic for pricing purposes, the firm instead released a statement from D’Amelio. “We are committed to the principle of equitable and affordable access for the Pfizer-BioNTech COVID-19 vaccine for people around the world,” said D’Amelio. “We have clearly stated in our public disclosures that we anticipate a pandemic phase that could last into 2022, where governments will be the primary purchasers of our vaccine.”

THE VACCINE MAKERS’ vague promises around affordability, while retaining a monopoly control of vaccine technology financed by public entities, have unsettled public health watchdogs.

Achal Prabhala — coordinator for the AccessIBSA project, which campaigns for access to medicines — notes that the U.S. government alone, through Operation Warp Speed, has pumped $18 billion into vaccine makers, in addition to advance payments for vaccines, ensuring that the pharmaceutical industry would face no financial risk.

“You know, Americans are amazed that they’re getting vaccines for free,” said Prabhala. “And of course they’re not because they’ve already paid for them once and now they’re amazed that they’re not paying for them twice.”

The pharmaceutical industry has faced declining public approval over the last decade. But the pandemic has presented a golden opportunity, noted Prabhala.

“Even though companies like Pfizer, which has not made the vaccine available to 85 percent of the world’s population, are enjoying immense popularity in the U.S. and Europe because of the fact that they got the vaccines done fast, and they seem to work well. That’s an unusually good position for pharma, they’re not used to being thought of as saviors,” he added.

But the companies have held out on drastic or even slight price increases on the vaccines, Prabhala continued, because they are managing the potential for reputational risk. “It’s pretty interesting that they are now waiting for the opportune time to raise prices once enough people have been vaccinated,” he added.

Taken From: https://theintercept.com/2021/03/18/covid-vaccine-price-pfizer-moderna/

Pfizer expects higher COVID-19 vaccine prices and yearly boosters, CFO says. And that means big sales long-term

Pfizer made headlines last month when its chief financial officer said the company would look to raise COVID-19 vaccine prices after the pandemic wanes. The company is doubling down on that stance, and it now believes annual vaccinations are “increasingly likely.”

Add those two things together, and you get a hefty long-term revenue stream.

During a recent virtual investor conference (PDF) hosted by Barclays, Pfizer Chief Financial Officer Frank D’Amelio said the company sees “significant opportunity” for its COVID-19 vaccine once the market shifts from a “pandemic situation to an endemic situation.”

Right now, the market is “clearly not being driven by what I’ll call normal market conditions,” D’Amelio explained to Barclays analyst Carter Gould during the virtual event. Instead, it’s “been driven by kind of the pandemic state that we’ve been in and the needs of governments to really secure doses from the various vaccine suppliers.”

Eventually, Pfizer expects “normal market forces … will start to kick in,” D’Amelio said.

At that point “factors like efficacy, booster ability, clinical utility will basically become very important, and we view that as, quite frankly, a significant opportunity for our vaccine from a demand perspective, from a pricing perspective, given the clinical profile of our vaccine,” D’Amelio told the analyst.  

RELATED: What does it take to supply COVID-19 vaccines across the globe? Here’s how the leading players are working it

Plus, Pfizer believes there will be demand for shots even after the current crisis. Citing variant concerns, Pfizer believes it’s “increasingly likely that an annual revaccination is going to take place” and that those revaccinations will be needed “for the foreseeable future,” the CFO said.

Pfizer has said it expects $15 billion in revenue from the mRNA vaccine this year, and that number could grow as the company negotiates new supply deals. At the Barclays event, D’Amelio said his company expects “return after taxes” of around 25% on the $15 billion figure, or around $3.75 billion. The CFO previously said he expects margins for the vaccine to grow over time.  

On the manufacturing front, Pfizer and BioNTech have made several upgrades to their supply chains and now plan to produce 2 billion doses this year. The company is “working to improve upon that number as well,” D’Amelio said.

RELATED: Pfizer eyes higher prices for COVID-19 vaccine after the pandemic wanes: exec, analyst

In the wake of AstraZeneca’s recent supply shortfalls in Europe, Pfizer and BioNTech expect to deliver 200 million doses there in the second quarter. Pfizer also expects to ship 300 million doses to the U.S. during the first half of the year.

Aside from its COVID-19 vaccine work, Pfizer sees an opportunity to improve on current flu vaccines with mRNA technology as well as to grow the market with a higher efficacy product, D’Amelio said at the event.

Taken from: https://www.fiercepharma.com/pharma/pfizer-sees-need-for-annual-revaccinations-and-rationale-for-higher-prices-after-pandemic