Vaccines for children. “The United States is now the first country in the world to offer a safe and effective COVID-19 vaccine for children under 6 months of age.”
In fact, we don’t know whether vaccines are safe and effective. The FDA’s hasty action was based on very weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid is not an emergency. The FDA bent its standards to an unusual degree and dismissed disturbing evidence that warrants more investigation.
As was initially done for adults, the FDA granted Pfizer and Moderna Vaccines for Toddlers an emergency-use authorization, allowing the agency to expedite access to products that treat “serious or life-threatening illnesses or diseases.” prevent situations.” While adult COVID vaccines apparently meet this standard in late 2020, toddler vaccines do not.
only 209 children Children between 6 months and 4 years old have died from Covid—about 0.02% of all virus deaths in the US about half the children were hospitalized with Covid between October 2020 and September 2021 as were those hospitalized with the flu during the previous winter. More children were hospitalized during the Omicron wave last winter, but hospitalization rates were still roughly in line with the 2019-20 flu season. None of the 5,400 or more children in Moderna’s trial were hospitalized for Covid. Yet at least 15 were hospitalized for non-Covid infections.
Two children in Pfizer’s test who became ill with Covid also tested positive for other viruses. It is possible that many hospitalizations due to Covid this winter were actually provoked or exacerbated by other viruses. Doctors had warned that more “immunologically nave” children were likely to get sick once schools reopen and lockdowns are lifted.
The evidence supporting the efficacy of Moderna and Pfizer vaccines in adults, at least at the time they were approved, was also far stronger. Both trials were large and robust enough to demonstrate 95% efficacy against infection with a strong degree of certainty. In contrast, the FDA authorized vaccines for children based on a comparison of antibodies generated in the original Wuhan version to those in young adults who had received two doses. But the two doses offer any protection against omicron infection in adults, and even have protection against hospitalization. Only around 40% to 60%.
At least Moderna’s trial showed a modest effect against symptomatic Omicron infections—37% in children 2 to 5 years old and 51% for children 6 months to 2 years old. Pfizer claimed its vaccine was 80% effective, but this is misleading. For one, Pfizer violated several clinical-trial conventions. Its initial protocol consisted of only two doses, but it failed to generate the antibody levels needed for FDA approval. So Pfizer added a third dose, which the FDA generously allowed. Usually, when the test fails, the agency does not allow drug manufacturers to modify the course.
Pfizer then planned to track at least 21 cases to establish a bare-bones measure of efficacy. By comparison, Moderna tracked more than 250 cases. Yet Pfizer shortened its data collection on April 29 — the day Moderna announced it had submitted its application for emergency-use authorization — even though only 10 cases were reported after the third dose. It’s not hard to conclude that Pfizer cut corners to avoid being beaten by Moderna. But as a result too few cases were documented for Pfizer to measure with any confidence the effectiveness of the vaccine. Pfizer nonetheless announced that its vaccine was 80% effective. Moderna scientists should be boiling. A Pfizer spokesperson says the FDA was more interested in vaccine “immunogenicity” data than efficacy among children and will conduct another efficacy analysis once more cases are detected.
More troubling in Pfizer’s trial, vaccinated toddlers were more likely to become seriously ill with COVID than those who received a placebo. Pfizer claimed that the majority of severe cases were not “clinically significant,” whatever that meant, but that was all the more reason the FDA needed longer follow-up before authorizing the vaccine.
It’s also worrying: Most of the children who developed multiple infections during the trial were vaccinated. This required further investigation, as experimental vaccines for other diseases sometimes increased the likelihood of infection.
Scientists are also finding that triple-vaccinated adults who were previously infected with the Wuhan variant have a weaker immune response to Omicron, making them more susceptible to reinfection. This phenomenon, called “immunological imprinting,” may suggest that children who received three shots of Pfizer were more likely to be re-infected.
The FDA dismissed the risk that vaccinating infants against a type that is no longer circulating could blunt their immune response to Omicron and its offshoots. There is a reason why vaccine trials usually take a decade. Some steps can be accelerated, but an extended follow-up is often necessary to make sure potential side effects are not overlooked.
The FDA standard for approving vaccines in otherwise healthy people, especially children, is considered higher than drugs intended to treat the sick. But the FDA markedly lowered its standards to approve COVID vaccines for toddlers. Why? Perhaps it felt pressure from the White House as well as worried parents. White House Covid Response Coordinator Ashish Jha Repeatedly told parents that he hoped vaccines for children would be approved and available in June. Remember how Mr Biden accused
By suggesting that they may be available before the November 2020 election, it pressured the FDA to approve the COVID vaccine.
Mr. Biden’s hypocrisy is hard to stomach. The FDA, to its credit, accelerates COVID treatments and vaccines when they are desperately needed. But the situation for children would have been better if the FDA had taken more time to ensure that vaccines are indeed safe and effective, even if it meant that America would not be the first.
Ms. Finlay is a member of the Journal’s editorial board.
Journal Editorial Report: The best and worst of the week from Kim Straussell, Kyle Peterson, Maine Ukueberuwa and Dan Henninger. Images: AP/Bloomberg Overall: Mark Kelly
opinion | Why the rush for toddler vaccines?
“This is a very historic milestone, an important step,” President Biden declared last week after being authorized by the Food and Drug Administration.
pfizer
And
modern
Vaccines for children. “The United States is now the first country in the world to offer a safe and effective COVID-19 vaccine for children under 6 months of age.”
In fact, we don’t know whether vaccines are safe and effective. The FDA’s hasty action was based on very weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid is not an emergency. The FDA bent its standards to an unusual degree and dismissed disturbing evidence that warrants more investigation.
As was initially done for adults, the FDA granted Pfizer and Moderna Vaccines for Toddlers an emergency-use authorization, allowing the agency to expedite access to products that treat “serious or life-threatening illnesses or diseases.” prevent situations.” While adult COVID vaccines apparently meet this standard in late 2020, toddler vaccines do not.
only 209 children Children between 6 months and 4 years old have died from Covid—about 0.02% of all virus deaths in the US about half the children were hospitalized with Covid between October 2020 and September 2021 as were those hospitalized with the flu during the previous winter. More children were hospitalized during the Omicron wave last winter, but hospitalization rates were still roughly in line with the 2019-20 flu season. None of the 5,400 or more children in Moderna’s trial were hospitalized for Covid. Yet at least 15 were hospitalized for non-Covid infections.
Two children in Pfizer’s test who became ill with Covid also tested positive for other viruses. It is possible that many hospitalizations due to Covid this winter were actually provoked or exacerbated by other viruses. Doctors had warned that more “immunologically nave” children were likely to get sick once schools reopen and lockdowns are lifted.
The evidence supporting the efficacy of Moderna and Pfizer vaccines in adults, at least at the time they were approved, was also far stronger. Both trials were large and robust enough to demonstrate 95% efficacy against infection with a strong degree of certainty. In contrast, the FDA authorized vaccines for children based on a comparison of antibodies generated in the original Wuhan version to those in young adults who had received two doses. But the two doses offer any protection against omicron infection in adults, and even have protection against hospitalization. Only around 40% to 60%.
At least Moderna’s trial showed a modest effect against symptomatic Omicron infections—37% in children 2 to 5 years old and 51% for children 6 months to 2 years old. Pfizer claimed its vaccine was 80% effective, but this is misleading. For one, Pfizer violated several clinical-trial conventions. Its initial protocol consisted of only two doses, but it failed to generate the antibody levels needed for FDA approval. So Pfizer added a third dose, which the FDA generously allowed. Usually, when the test fails, the agency does not allow drug manufacturers to modify the course.
Pfizer then planned to track at least 21 cases to establish a bare-bones measure of efficacy. By comparison, Moderna tracked more than 250 cases. Yet Pfizer shortened its data collection on April 29 — the day Moderna announced it had submitted its application for emergency-use authorization — even though only 10 cases were reported after the third dose. It’s not hard to conclude that Pfizer cut corners to avoid being beaten by Moderna. But as a result too few cases were documented for Pfizer to measure with any confidence the effectiveness of the vaccine. Pfizer nonetheless announced that its vaccine was 80% effective. Moderna scientists should be boiling. A Pfizer spokesperson says the FDA was more interested in vaccine “immunogenicity” data than efficacy among children and will conduct another efficacy analysis once more cases are detected.
More troubling in Pfizer’s trial, vaccinated toddlers were more likely to become seriously ill with COVID than those who received a placebo. Pfizer claimed that the majority of severe cases were not “clinically significant,” whatever that meant, but that was all the more reason the FDA needed longer follow-up before authorizing the vaccine.
It’s also worrying: Most of the children who developed multiple infections during the trial were vaccinated. This required further investigation, as experimental vaccines for other diseases sometimes increased the likelihood of infection.
Scientists are also finding that triple-vaccinated adults who were previously infected with the Wuhan variant have a weaker immune response to Omicron, making them more susceptible to reinfection. This phenomenon, called “immunological imprinting,” may suggest that children who received three shots of Pfizer were more likely to be re-infected.
The FDA dismissed the risk that vaccinating infants against a type that is no longer circulating could blunt their immune response to Omicron and its offshoots. There is a reason why vaccine trials usually take a decade. Some steps can be accelerated, but an extended follow-up is often necessary to make sure potential side effects are not overlooked.
The FDA standard for approving vaccines in otherwise healthy people, especially children, is considered higher than drugs intended to treat the sick. But the FDA markedly lowered its standards to approve COVID vaccines for toddlers. Why? Perhaps it felt pressure from the White House as well as worried parents. White House Covid Response Coordinator Ashish Jha Repeatedly told parents that he hoped vaccines for children would be approved and available in June. Remember how Mr Biden accused
Donald Trump
By suggesting that they may be available before the November 2020 election, it pressured the FDA to approve the COVID vaccine.
Mr. Biden’s hypocrisy is hard to stomach. The FDA, to its credit, accelerates COVID treatments and vaccines when they are desperately needed. But the situation for children would have been better if the FDA had taken more time to ensure that vaccines are indeed safe and effective, even if it meant that America would not be the first.
Ms. Finlay is a member of the Journal’s editorial board.
Journal Editorial Report: The best and worst of the week from Kim Straussell, Kyle Peterson, Maine Ukueberuwa and Dan Henninger. Images: AP/Bloomberg Overall: Mark Kelly
Copyright © 2022 Dow Jones & Company, Inc. All rights reserved. 87990cbe856818d5eddac44c7b1cdeb8