TrialSite Staff by Staff at TrialSite | Quality Journalism May. 10, 2022, 9:00 a.m.

After 16 months of major COVID-19 immunization initiatives worldwide, government appetite for COVID-19 vaccine products appears to morph into a more focused, market-based, targeted booster series, a change that vaccine producers are now adjusting to accommodate. With a confluence of forces, from COVID-19 vaccine gluts to increasing numbers of producers to leeriness of waning effectiveness due to highly transmissible variants, the market drivers, heavily driven by government, give way to an unfolding new reality.

In the United States, like in many other nations, including those aligned with the World Health Organization (WHO), centered responses to COVID-19 emphasized production and distribution of a maximum number of vaccines with targets of achieving at least 70% vaccination. That effort, again coordinated to some degree by groups such as WHO, led to the inoculation of about 4.68 billion people (according to Our World in Data) worldwide, or neatly 60% of humanity, representing an unprecedented pandemic response.

Vaccine producers such as Pfizer, Moderna, Johnson and Johnson (Janssen), AstraZeneca, and others understand that unless there are continued government mandates effectively priming the pump of demand, those individuals with a preference for COVID-19 immunization have already gone ahead with the procedure.

What’s left is a market for boosters and what could become some sort of annual shot available for targeted populations. Of course, in some markets, young children are still a target for COVID-19 vaccines.  Regardless, companies now operate in a quite different environment now, than they did in the period of late 2020 through 2021: a period driven by massive government spending, heavy industry influence on the regulatory process, risk-sharing, and the like to a more traditional competitive marketplace.

The Last Market: Young Children

While the children’s markets in places like America are still relevant, awaiting approval, what’s becoming apparent will be the emphasis on booster shots. In the world’s most lucrative drug market, America, Pfizer, and Moderna will more than likely persist as market leaders vying for the parental demands of children as public health agencies such as the CDC continue to emphasize that the risk-benefit analysis of the COVID-19 vaccine favor by a long-shot vaccination. The point of view is that there are no risk-free choices and that it’s better to be safe than sorry with the very youngest members of society. 

To date, the CDC recommends the Pfizer vaccine for both the 5-11 age and 12 to 17 cohort while not recommending Moderna. Under 4 is the last market segment the vaccine makers vie for, and if the FDA authorizes, then Pfizer would own that market. A potential battle emerges over this cohort (aged 4-11) as a growing movement concerned for the safety associated with the vaccines, especially the mRNA-based products, gains momentum to question the mass vaccination on this young population. Critics argue that the original premise for mandates and the like was to control community transmission.  Given substantial waning vaccine effectiveness combined with mutating variants, critics suggest the risks of serious infection and death are too low, and the safety issues are higher than the government is letting on. 

Demand for Vaccines Wane

But demand for vaccines is flat in much of the world. In America, there is little uptick in vaccination as the “fully vaccinated” defined as receiving the two jabs of either Pfizer-BioNTech, Moderna or one jab from Janssen equals 66.8% of the population while about 30.7% of the population opted for a booster dose.

Meanwhile, TrialSite, on several occasions, has chronicled a global glut of COVID-19 vaccines and therapeutics, especially in places like India, the world’s second-highest populated country. In places like Australia, where the death rate associated with COVID-19 has absolutely skyrocketed despite high immunization rates, the public health agencies and politicians continue to promote booster doses as the answer. TrialSite reported recently that Australian politicians in an election season essentially pretend that times are back to normal despite record numbers of cases, near-record hospitalizations, and double the deaths in the first months of 2022 than all of 2020 and 2021 combined.

Some Possible Explanations

Reuters’ Michael Erman and Manas Mishra write that vaccine producers such as Novavax and CureVac, the German mRNA-vaccine maker in partnership with GlaxoSmithKline, seek to target this booster market. Novavax still awaits FDA authorization despite the fact that much of the developed world, from Europe to Canada and Japan to the WHO, have authorized the use of the Novavax vaccine.

Meanwhile, the outlook for Janssen and AstraZeneca (Oxford) is that bright, report the Reuters journalists. According to Hartaj Singh, an analyst from Oppenheimer & Co., “It becomes a very competitive game with companies battling it out with pricing and for market share, even for vaccines that are considered to be the best, like Pfizer and Moderna.”

Interestingly, Pfizer’s CEO Albert Bourla went on the record in an interview recently that those adults that have opted to receive a COVID-19 vaccine are not likely to start accepting shots now in a recognition that the mega push for vaccine administration has come and gone.

Moderna has pegged the unfolding market as the annual shot market, targeting the following:

• Adults 50 and above
• People with comorbidities or other risks
• High-risk occupations (e.g., healthcare, etc.)

According to the estimates of Stephane Bancel, Moderna’s CEO, this emerging annual shot market totals 1.7 billion, representing 21% of the global population. The mRNA-based vaccines are more expensive and cumbersome to distribute and store, hence a sizeable chunk of that estimated target may opt for other vaccines such as the two recently touted by vaccine insiders at WHO including a plant-based vaccine from Canada and one from China. 

More than likely Western Europe and America will represent central markets for sales for Pfizer and Moderna who will move toward more competitive, targeted responsive strategies as large government pre-purchases are probably going to be far less. Moreover, TrialSite suggests what were cozy relationships between industry and government agencies will become less so as the various governments’ responses to the pandemic will be a hot topic, especially in democracies in current election cycles.

Key Question: A flu shot model or something else?

The Reuters writers posed an important question in the recent piece: will the likes of Pfizer and Moderna starting this fall market a tailored, redesigned vaccine targeted relevant variants of concern (e.g., Omicron, BA.2, etc.)?

Both Moderna and Pfizer executives are on the record that they are developing Omicron-targeted vaccines.

This becomes an important topic as even the mainstream media starts to become slightly critical of the pandemic response, including mRNA-based vaccine makers that never modified the vaccine product once. The vaccine authorized and approved in the United States was developed based on the original Wuhan variant of SARS-CoV-2 which didn’t seem to make it in circulation to America nor most of the world.

Revenues Decline (but still unprecedented)

2023 sales numbers, while still staggering as compared to historical precedent in the pharmaceutical industry, are nonetheless, on the decline. Reuters reports $17 billion projected for Pfizer-BioNTech (down nearly half from $34 billion) and $10 billion for Moderna as compared to $23 billion in 2022. Sales will continue to drop because enormous fortunes were generated in the winner-take-all pandemic market.

TrialSite suggests the COVID-19 pandemic response must be seriously evaluated due to levels of bias, political interference, and potentially corruption at an unprecedented level. Should the political conditions change in the United States for example, leading to serious inquiries, the pandemic winners may incur unexpected costs.

After 16 months of major COVID-19 immunization initiatives worldwide, government appetite for COVID-19 vaccine products appears to morph into a more focused, market-based, targeted booster series, a change that vaccine producers are now adjusting to accommodate. With a confluence of forces, from COVID-19 vaccine gluts to increasing numbers of producers to leeriness of waning effectiveness due to highly transmissible variants, the market drivers, heavily driven by government, give way to an unfolding new reality.

In the United States, like in many other nations, including those aligned with the World Health Organization (WHO), centered responses to COVID-19 emphasized production and distribution of a maximum number of vaccines with targets of achieving at least 70% vaccination. That effort, again coordinated to some degree by groups such as WHO, led to the inoculation of about 4.68 billion people (according to Our World in Data) worldwide, or neatly 60% of humanity, representing an unprecedented pandemic response. TrialSite Staff by Staff at TrialSite | Quality Journalism

May. 10, 2022, 9:00 a.m.

After 16 months of major COVID-19 immunization initiatives worldwide, government appetite for COVID-19 vaccine products appears to morph into a more focused, market-based, targeted booster series, a change that vaccine producers are now adjusting to accommodate. With a confluence of forces, from COVID-19 vaccine gluts to increasing numbers of producers to leeriness of waning effectiveness due to highly transmissible variants, the market drivers, heavily driven by government, give way to an unfolding new reality.

In the United States, like in many other nations, including those aligned with the World Health Organization (WHO), centered responses to COVID-19 emphasized production and distribution of a maximum number of vaccines with targets of achieving at least 70% vaccination. That effort, again coordinated to some degree by groups such as WHO, led to the inoculation of about 4.68 billion people (according to Our World in Data) worldwide, or neatly 60% of humanity, representing an unprecedented pandemic response.

Vaccine producers such as Pfizer, Moderna, Johnson and Johnson (Janssen), AstraZeneca, and others understand that unless there are continued government mandates effectively priming the pump of demand, those individuals with a preference for COVID-19 immunization have already gone ahead with the procedure.

What’s left is a market for boosters and what could become some sort of annual shot available for targeted populations. Of course, in some markets, young children are still a target for COVID-19 vaccines.  Regardless, companies now operate in a quite different environment now, than they did in the period of late 2020 through 2021: a period driven by massive government spending, heavy industry influence on the regulatory process, risk-sharing, and the like to a more traditional competitive marketplace.

The Last Market: Young Children

While the children’s markets in places like America are still relevant, awaiting approval, what’s becoming apparent will be the emphasis on booster shots. In the world’s most lucrative drug market, America, Pfizer, and Moderna will more than likely persist as market leaders vying for the parental demands of children as public health agencies such as the CDC continue to emphasize that the risk-benefit analysis of the COVID-19 vaccine favor by a long-shot vaccination. The point of view is that there are no risk-free choices and that it’s better to be safe than sorry with the very youngest members of society. 

To date, the CDC recommends the Pfizer vaccine for both the 5-11 age and 12 to 17 cohort while not recommending Moderna. Under 4 is the last market segment the vaccine makers vie for, and if the FDA authorizes, then Pfizer would own that market. A potential battle emerges over this cohort (aged 4-11) as a growing movement concerned for the safety associated with the vaccines, especially the mRNA-based products, gains momentum to question the mass vaccination on this young population. Critics argue that the original premise for mandates and the like was to control community transmission.  Given substantial waning vaccine effectiveness combined with mutating variants, critics suggest the risks of serious infection and death are too low, and the safety issues are higher than the government is letting on. 

Demand for Vaccines Wane

But demand for vaccines is flat in much of the world. In America, there is little uptick in vaccination as the “fully vaccinated” defined as receiving the two jabs of either Pfizer-BioNTech, Moderna or one jab from Janssen equals 66.8% of the population while about 30.7% of the population opted for a booster dose.

Meanwhile, TrialSite, on several occasions, has chronicled a global glut of COVID-19 vaccines and therapeutics, especially in places like India, the world’s second-highest populated country. In places like Australia, where the death rate associated with COVID-19 has absolutely skyrocketed despite high immunization rates, the public health agencies and politicians continue to promote booster doses as the answer. TrialSite reported recently that Australian politicians in an election season essentially pretend that times are back to normal despite record numbers of cases, near-record hospitalizations, and double the deaths in the first months of 2022 than all of 2020 and 2021 combined.

Some Possible Explanations

Reuters’ Michael Erman and Manas Mishra write that vaccine producers such as Novavax and CureVac, the German mRNA-vaccine maker in partnership with GlaxoSmithKline, seek to target this booster market. Novavax still awaits FDA authorization despite the fact that much of the developed world, from Europe to Canada and Japan to the WHO, have authorized the use of the Novavax vaccine.

Meanwhile, the outlook for Janssen and AstraZeneca (Oxford) is that bright, report the Reuters journalists. According to Hartaj Singh, an analyst from Oppenheimer & Co., “It becomes a very competitive game with companies battling it out with pricing and for market share, even for vaccines that are considered to be the best, like Pfizer and Moderna.”

Interestingly, Pfizer’s CEO Albert Bourla went on the record in an interview recently that those adults that have opted to receive a COVID-19 vaccine are not likely to start accepting shots now in a recognition that the mega push for vaccine administration has come and gone.

Moderna has pegged the unfolding market as the annual shot market, targeting the following:

• Adults 50 and above
• People with comorbidities or other risks
• High-risk occupations (e.g., healthcare, etc.)

According to the estimates of Stephane Bancel, Moderna’s CEO, this emerging annual shot market totals 1.7 billion, representing 21% of the global population. The mRNA-based vaccines are more expensive and cumbersome to distribute and store, hence a sizeable chunk of that estimated target may opt for other vaccines such as the two recently touted by vaccine insiders at WHO including a plant-based vaccine from Canada and one from China. 

More than likely Western Europe and America will represent central markets for sales for Pfizer and Moderna who will move toward more competitive, targeted responsive strategies as large government pre-purchases are probably going to be far less. Moreover, TrialSite suggests what were cozy relationships between industry and government agencies will become less so as the various governments’ responses to the pandemic will be a hot topic, especially in democracies in current election cycles.

Key Question: A flu shot model or something else?

The Reuters writers posed an important question in the recent piece: will the likes of Pfizer and Moderna starting this fall market a tailored, redesigned vaccine targeted relevant variants of concern (e.g., Omicron, BA.2, etc.)?

Both Moderna and Pfizer executives are on the record that they are developing Omicron-targeted vaccines.

This becomes an important topic as even the mainstream media starts to become slightly critical of the pandemic response, including mRNA-based vaccine makers that never modified the vaccine product once. The vaccine authorized and approved in the United States was developed based on the original Wuhan variant of SARS-CoV-2 which didn’t seem to make it in circulation to America nor most of the world.

Revenues Decline (but still unprecedented)

2023 sales numbers, while still staggering as compared to historical precedent in the pharmaceutical industry, are nonetheless, on the decline. Reuters reports $17 billion projected for Pfizer-BioNTech (down nearly half from $34 billion) and $10 billion for Moderna as compared to $23 billion in 2022. Sales will continue to drop because enormous fortunes were generated in the winner-take-all pandemic market.

TrialSite suggests the COVID-19 pandemic response must be seriously evaluated due to levels of bias, political interference, and potentially corruption at an unprecedented level. Should the political conditions change in the United States for example, leading to serious inquiries, the pandemic winners may incur unexpected costs.

After 16 months of major COVID-19 immunization initiatives worldwide, government appetite for COVID-19 vaccine products appears to morph into a more focused, market-based, targeted booster series, a change that vaccine producers are now adjusting to accommodate. With a confluence of forces, from COVID-19 vaccine gluts to increasing numbers of producers to leeriness of waning effectiveness due to highly transmissible variants, the market drivers, heavily driven by government, give way to an unfolding new reality.

In the United States, like in many other nations, including those aligned with the World Health Organization (WHO), centered responses to COVID-19 emphasized production and distribution of a maximum number of vaccines with targets of achieving at least 70% vaccination. That effort, again coordinated to some degree by groups such as WHO, led to the inoculation of about 4.68 billion people (according to Our World in Data) worldwide, or neatly 60% of humanity, representing an unprecedented pandemic response.