COVID Policies Should Be Decided by Public Health Agencies, Not Corporations

The grinding two-plus years of the pandemic have yielded outsize benefits for one company — Pfizer — making it both highly influential and hugely profitable as COVID-19 continues to infect tens of thousands of people and kill hundreds each day.

The drugmaker’s success in developing COVID drugs has given it unusual weight in U.S. health policy. Based on internal research, the company’s executives have frequently announced the next stage in the fight against the pandemic before government officials have had time to study the issue, annoying many experts in the medical field and leaving some patients unsure whom to trust.

Pfizer’s 2021 revenue$81.3 billion roughly doubleIn 2020, its top sellers were a vaccine against pneumonia, Ibrance for cancer, and Lyrica to treat fibromyalgia.

Its mRNA vaccination now has 70% market share in the U.S. Its antiviral Paxlovid, which treats early symptoms of COVID, is the preferred choice. The company anticipates that it will generate more than $50 Billion in global revenue this year from the two medications.

Paxlovid’s value to vaccinated patients isn’t yet clear, and Pfizer’s COVID vaccine doesn’t entirely prevent infections, although each booster temporarily restores some protection. Yet, while patients may recoil at the need for repeated injections — two boosters are now recommended for people 50 and older — the requirement is gold for investors.

“Hopefully, we could be giving it annually and maybe for some groups that are high-risk more often,” CEO Albert Bourla told investorsThis year. “Then you have the treatment [Paxlovid] that will, let’s say, resolve the issues of those that are getting the disease.”

Just last week, the Biden administration agreed to buy another 105 million doses of Pfizer’s COVID vaccine for the fall booster campaign, paying $3.2 billion. At $30.47 a dose, it’s a significant premium over the $19.50-a-dose rate the government paid for the first 100 million. Although the vaccine is being modified to target early-omicron variants of the disease, newer variants are taking over.

Because the virus keeps mutating and will be around for a long time, the market for Pfizer’s products won’t go away. The public will be more satisfied in wealthier countries than in less developed countries.

The U.S. response to the pandemic, which included critical decisions regarding public health, has been influenced by Pfizer products.

When last year Bourla suggestedA booster shot is likely to be required soon. U.S. public health officialsPfizer-BioNTech followed the lead, giving the impression Pfizer was singing the tune. Some public health experts and scientists worry these decisions were hasty, noting, for example, that although boosters with the mRNA shots produced by Moderna and Pfizer-BioNTech improve antibody protection initially, it generally doesn’t last.

Since January Bourla has been sayingSenior FDA officials have indicated that the majority of Americans will need annual booster shots. indicated since April that they agree.

Pfizer presented studies showing that its COVID vaccine was able to produce more antibodies against the Omicron variant that started circulating in December. This was at FDA advisers’ meeting on June 28. Most of the advisors agreed that the FDA should require that the next vaccine target a newer variant of the omicron virus, also known as BA.

That would mean more work and expense for Pfizer, which called on the FDA to enable it to make future changes to the COVID vaccine without human trials — similar to how annual influenza vaccines are approved. “If such a process were implemented, responses to future waves could be substantially accelerated,” said Kena Swanson, Pfizer’s vice president for viral vaccines.

FDA officials were not available to respond immediately to the suggestion.

As societies abandon other efforts to control COVID’s spread, such as mask mandates and physical distancing, Pfizer’s prospects look even brighter, especially now that the company has brought out the first oral COVID treatment, Paxlovid.

“People are going to get out there,” Angela Hwang, president of Pfizer Biopharmaceuticals Group, told investors May 3. “We know with all of that, infections are going to increase, and that’s the role that Paxlovid can play.”

A Pfizer official could spin this story during a recent investor conference. recent reportsPaxlovid may be able to disguise the virus from them, which is good news. It also predicts that patients may require multiple courses of treatment.

Immunocompromised patients “may carry this virus for a very, very long time,” Dr. Mikael Dolsten said in the investor call. “And we see that area as a real new opportunity growth area for Paxlovid to do very well, where you may need to take multiple courses.”

Pfizer has spent a lot to boost its influence during the pandemic. Since early 2020, it has spent a lot of money. more than $25 millionFor in-house lobbying and payments for 19 lobbying firms, pushing legislation to protect its products as well as promote stronger U.S. vaccine programs.

Pfizer’s donations to political candidates in the 2020 cycle were larger than those of any other drug company, totaling about $3.5 million, with the largest share going to Democrats. Joe Biden got $351,000; Donald Trump just $103,000.

Unlike Moderna, Sanofi, Novavax, and Johnson & Johnson, which got billions of dollars in U.S. support, Pfizer did not seek government money to develop its vaccine, saying it would work independently.

Pfizer did not benefit from the $445 million the German government provided to BioNTech, Pfizer’s partner in developing the vaccine. Pfizer was largely dependent on U.S. logistical support in the end, according to a new bookPaul Mango, a former Health and Human Services official.

Pfizer made $7.8billion in U.S. revenue in 2021 for its COVID vaccine. The government can purchase 1.6billion doses of Pfizer vaccines. It has already purchased 900million at not-for profit prices and donated 500 million to poor countries.

Pfizer’s terms in the contracts exclude many taxpayer protections. They deny the government any intellectual property rights and say that federal spending played no role in the vaccine’s development — even though National Institutes of Health scientists invented a key feature of Pfizer’s vaccine, said Robin Feldman, a patent law expert at the University of California.

“The agreement could set a precedent,” in which another company could cite Pfizer’s contracts to argue the government has surrendered any rights to an invention, she said.

The government has also agreed to purchase approximately 20 million five-day Paxlovid courses for $530 each.

Bourla stated that the prices for the COVID drug or vaccine will increase once the pandemic period ends. at a January event, “to reflect the cutting-edge technology.”

Pfizer spokesperson Sharon Castillo declined to respond to specific questions about Pfizer’s influence on pandemic policy. She released a statement saying that “since Day 1 of this pandemic, we have been laser-focused on working collaboratively with all relevant stakeholders to bring to the world two medical breakthroughs. In doing so, we have moved at the speed of science, complied with the strict regulatory processes, and relied on our scientists’ expertise and manufacturing prowess.”

It is evident that the company made a scientific breakthrough in quickly responding to the pandemic’s medical needs. It used artificial intelligenceTo track the spread of the virus, find the best places to recruit volunteers, Paxlovid deployed rapid drug-screening tools.

Its success in the COVID vaccine raised hopes a Pfizer vaccine for respiratory syncytial virus, which can pose a danger to older adults and babies. The company is also seeking licensure to provide shots that protect against Lyme disease or hospital infections.

Pfizer had been long reluctant to enter the vaccine business because of its historically low financial returns. In the 1960s, the company stopped producing vaccines for humans due to the recall of its measles vaccine. This vaccine caused serious illness in scores of children and caused an unexpected reaction with the antibodies stimulated by it. Wyeth was making an uncommonly effective and profitable vaccine against ear infections and pneumonia. In 2009, the company returned to the field.

Pfizer has become a global powerhouse. Pfizer will be a global leader in 2021. hired nearly 2,400 people. “We are a household name right now to billionsOf people,” Bourla said in January. “People are trusting the Pfizer vaccines.”

The company’s power worries some vaccinologists, who see its growing influence in a realm of medical decision-making traditionally led by independent experts.

During a recent investor call, analyst Evan Seigerman of BMO Capital Markets asked whether the world was “kind of walking blindly into recommending boosters” so frequently.

Data from Israel, which uses only Pfizer’s vaccine and has provided most of the studiesThe Centers for Disease Control and Prevention have recommended vaccination boosters. These recommendations suggest that the third and fourth doses (or more) of the mRNA vaccines increase antibodies levels, which quickly decrease again. Some people over 60 have survived with added boosters, but data on the benefits to younger adults is not clear.

When President Biden in September 2021 offered boosters to Americans — not long after Bourla had recommended them — Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a developer of a vaccine for an intestinal virus, wondered, “Where’s the evidence you are at risk of serious disease when confronted with COVID if you are vaccinated and under 50?”

Offit stated that policies regarding booster recommendations for different groups of people are complex and changing. However, the CDC should be making them, not Bourla or Pfizer.

“We’re being pushed along,” he said. “The pharmaceutical companies are acting like public health agencies.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. With Policy Analysis and Polling, KHNThis is one of three major operating programs. KFF(Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information to the nation on health issues.