As Pfizer makes plans to keep its billion dollar revenue stream going — by assuring investors yearly COVID booster doses will be needed long after the pandemic ends — a group of scientists from the Centers for Disease Control and Prevention (CDC) said there isn’t enough data to recommend COVID booster shots to the general population.
The COVID-19 working group of the CDC’s Advisory Committee on Immunization Practices (ACIP) said June 23, they would only recommend booster shots if there’s a demonstrated decline in efficacy –– not just a waning antibody response.
Boosters may also be recommended if there’s a variant that’s able to evade the vaccines, according to slides presented by Sara Oliver, M.D., a medical epidemiologist with CDC’s National Center for Immunization and Respiratory Diseases.
Currently, there’s no evidence to suggest a booster is needed, the experts said. Boosters may be appropriate for special risk groups in the future, including elderly people and transplant recipients. To be sure, the nation’s top public health officials said they would continue to monitor the situation.
“I would have to agree with the interpretation of the working group in the sense that there’s no data to support recommendations to support boosters at this time,” said Dr. Sharon Frey, member of the ACIP and clinical director of the Center for Vaccine Development at Saint Louis University Medical School. “There’s no evidence against declining protection at this time.”
Dr. Grace Lee, chair of the ACIP safety panel and professor of pediatrics at Stanford University School of Medicine, said she would like to see more evidence of breakthrough cases before recommending a booster shot.
“I would want greater certainty on the safety data if we’re talking about boosting before it’s clear what the risk data will look like,” Lee said. “If we’re seeing severe breakthrough cases then I think the decision-making moves forward even if there’s uncertainty with the safety data.”
CDC expert recommendations threaten Pfizer profits
Booster shots for COVID are expected to serve as a key revenue driver in the years to come for Pfizer and Moderna. Pfizer executives have assured investors the company sees the vaccine market evolving as the pandemic wanes, and will likely be able to charge more per dose than it was getting under pandemic supply deals.
Pfizer has been working on two different booster strategies it anticipates could carry sales beyond the immediate pandemic need — a third 30 mg dose of its current vaccines and an updated vaccine that targets the South African variant, Fierce Pharma reported.
No one is completely sure when a booster will be needed, but it’s possible that some of those who were vaccinated early on may need an extra jab as early as September, or roughly 8 to 12 months after their initial regimen, CEO Albert Bourla told Axios in May.
Pfizer has argued that boosters would be required “as antibody blood concentration wanes to ensure the broad population can’t carry the virus and thus quench the epidemic faster,” the Bernstein analysts, led by Ronny Gal, wrote to clients. That’s not the industry’s standard, and it’s also not what the CDC’s ACIP suggested at its meeting June 23, analysts wrote.
A Pfizer spokesperson told Fierce Pharma the company’s “current thinking is that until we see a reduction in SARS-CoV-2 circulation and COVID-19 disease, we think it is possible that a third dose, a boost of our vaccine, could be needed to help provide protection against COVID-19,” subject to regulatory approval.
Pfizer’s COVID vaccine is already the second-highest revenue-generating drug in the world, with a projected revenue forecast of $26 billion in 2021 alone — a 70% increase in its originally projected profits.
The forecast is based on contracts to deliver 1.6 billion vaccine doses this year. The company expects to sign more deals for this year and is in supply talks with several countries for 2022 and beyond.
During an investor conference in March, Pfizer’s CFO Frank D’Amelio said the company sees “significant opportunity” for its COVID vaccine once the market shifts from a “pandemic situation to an endemic situation.”
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.
During the Barclays’ Global Health Conference in March, D’Amelio said the company doesn’t see this as a one-time event, but “as something that’s going to continue for the foreseeable future.”
Bourla said a third dose of the company’s COVID vaccine was “likely” to be needed within a year of the initial two-dose inoculation — followed by annual vaccinations.
“Every year, you need to go to get your flu vaccine,” Bourla said. “It’s going to be the same with COVID. In a year, you will have to go and get your annual shot for COVID to be protected.”
Like Pfizer, Moderna’s chief commercial officer, Corinne M. Le Goff said during a call with investors in April that Americans could start getting booster shots of its vaccine later this year to protect against COVID variants.
“It is likely that the countries that have already achieved high vaccine coverage are going to be ready to shift their focus to boosters in 2022, and possibly even starting at the end of this year,” Le Goff said.
Johnson & Johnson (J&J) has said its vaccine will probably need to be given annually, despite being heavily marketed to consumers as a one-dose vaccine.
As The Defender reported in May, pharmaceutical companies and their CEOs have made billions from COVID vaccines, massive compensation packages and questionable stock sales while reassuring investors that plans were underway for boosters and annual shots.