Post by Nadica (She/Her) on Sept 15, 2024 0:03:02 GMT
Despite FDA recommendations Florida Surgeon General Ladapo warns against new COVID booster - Published Sept 13, 2024
By C. A. Bridges
The summer COVID-19 surge continues, with nearly half the country reporting "very high" levels of COVID activity as measured by wastewater data, according to the Centers for Disease Control and Prevention (CDC).
The new COVID vaccine is now available at CVC and Walgreens and through clinics and healthcare providers. With the release of the vaccine, Florida Surgeon General Joseph Ladapo is urging everyone to stay up to date... with information about how dangerous it is.
In a statement Thursday with the title, "Updated Guidance for COVID-19 Boosters for the Fall and Winter 2024–2025 Season," the Florida Department of Health repeated the same arguments against mRNA COVID shots that Ladapo used when he recommended against their use in January, saying the U.S. Food and Drug Administration did not provide an adequate response to his questions regarding the drugs' safety.
"Based on the high rate of global immunity and currently available data, the State Surgeon General advises against the use of mRNA COVID-19 vaccines," the FDOH statement said.
The FDA's response to Ladapo in December rebutted each of his concerns, warning that vaccine "misinformation and disinformation" would result in fewer people getting vaccinated, which contributes to the "continued death and serious illness toll of COVID-19."
COVID-19 rates in Florida
In Florida, cases for August dropped from last year's numbers, with 62,038 reported cases this year compared to 91,941 in August 2023. Both numbers are almost certainly low as many people self-test at home and some may have it and never test at all.
Deaths from COVID were on par with last year, however, with 828 last August compared to 877 in 2023. The average death total for the four months prior this year was 265.
So far 8.2 million Floridians have been infected with COVID-19 at least once, according to FDOH data, and 97,250 have died.
Ladapo says vaccine won't protect against new strains despite FDA assurances
Along with a lengthy list of concerns over the effectiveness and health risks of mRNA vaccines and boosters, the FDOH statement warned that "this booster does not protect against the currently dominant strain, accounting for approximately 37% of infections in the United States" and said that the vaccine was approved without specific trials in humans.
The FDA said in a release that the updated vaccines granted an emergency use authorization for distribution this fall were designed to target the KP.2 strain but also "more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death."
As of the latest CDC's Nowcast data tracker, which displays COVID-19 estimates and projections for two-week periods, the Omicron KP.3.1.1 variant accounted for 52.7% of positive infections between Sept. 1 and Sept. 14, followed by KP.2.3 at 12.2%, with LB.1 at 10.9% and KP.3 at 10.6%.
“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
The Centers for Disease Control and Prevention (CDC) recommends that everyone ages 6 months and older receive an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 for this fall and winter season.
Ladapo's history of COVID vaccine criticism
September 2021: Within a day of being hired, Ladapo signed new rules allowing parents to decide if children exposed to COVID could go to school anyway, eliminating the previous requirement for exposed students to quarantine off campus for at least four days.
October 2021: Ladapo appeared at DeSantis' side in public appearances, supporting the governor's views on blocking vaccine and mask mandates and accusing the public health community of fearmongering. Critics accused him of spreading misinformation that led to people being hesitant or afraid of vaccines. A firestorm of criticism erupted after Ladapo refused to wear a mask around Democratic state Sen. Tina Polsky even after she told him she had a serious medical condition (later confirmed as breast cancer) and was at a higher risk for serious complications from COVID.
December 2021: The Florida Department of Health rejected a complaint about Ladapo that said he violated state medical laws by publicly casting doubts about COVID vaccines and promoting unproven treatments.
January 2022: At a press conference, DeSantis and Ladapo told Floridians who weren't showing symptoms not to get tested. “If you don’t have symptoms, you are not a case," Ladapo said, in defiance of CDC and virologist recommendations.
June 2022: DeSantis and the FDOH, under Ladapo, refused to pre-order COVID-19 vaccines for children under five when they became available, the only U.S. state to do so, citing the lack of need and the risks. Ladapo appeared before Congress to defend the state's decision and said the state didn't recommend vaccines for children under 18.
October 2022: Ladapo urged men younger than 40 to avoid the Pfizer and Moderna mRNA vaccine and booster shots because of the "abnormally high risk of cardiac-related death among men in this age group," citing an anonymous non-peer-reviewed analysis from the FDOH. The move prompted a backlash from doctors, researchers and the federal government. At the time, Florida was leading the country in COVID deaths for the third month in a row.
January 2023: A task force of University of Florida medical school doctors concluded that the FDOH recommendation against COVID vaccines for young men was of “highly questionable merit" and that Ladapo cherry-picked data to support his stance. Politico went further and, after examining different drafts of the analysis, reported that Ladapo had personally changed the study to remove data that contradicted his views. Ladapo has denied this.
March 2023: In response to a letter from Ladapo demanding answers based on his own research on vaccine safety, the FDA and CDC asked him to stop disproportionally focusing on the small number of adverse effects in the studies of 13 billion COVID shots given around the world while ignoring the number of people the vaccines have saved.
April 2023: The FDOH under Ladapo stopped reporting COVID infections and deaths to the federal government
September 2023: Ladapo recommended against anyone under the age of 65 getting the new COVID-19 vaccine booster the FDA approved to combat new, more infectious variants, directly contradicting CDC guidance. He claimed that the mRNA boosters altered human DNA, which the CDC and multiple studies have said is false.
November 2023: After a two-year battle over COVID public records, the FDOH under Ladapo settled a lawsuit about withholding COVID data and released information spanning the entire duration of the pandemic on the state's FLHealthCHARTS.gov site. However, the agency also stopped providing cumulative totals, percentages, new case positivity, data on booster doses and overviews that made it easier to see trends.
January 2024: Ladapo made headlines again by "calling for a halt to the use of mRNA COVID-19 vaccines" because he said he didn't receive an adequate response from the FDA about the safety of vaccines. Meanwhile, Florida was seeing a spike in new COVID cases and hospitalizations.
By C. A. Bridges
The summer COVID-19 surge continues, with nearly half the country reporting "very high" levels of COVID activity as measured by wastewater data, according to the Centers for Disease Control and Prevention (CDC).
The new COVID vaccine is now available at CVC and Walgreens and through clinics and healthcare providers. With the release of the vaccine, Florida Surgeon General Joseph Ladapo is urging everyone to stay up to date... with information about how dangerous it is.
In a statement Thursday with the title, "Updated Guidance for COVID-19 Boosters for the Fall and Winter 2024–2025 Season," the Florida Department of Health repeated the same arguments against mRNA COVID shots that Ladapo used when he recommended against their use in January, saying the U.S. Food and Drug Administration did not provide an adequate response to his questions regarding the drugs' safety.
"Based on the high rate of global immunity and currently available data, the State Surgeon General advises against the use of mRNA COVID-19 vaccines," the FDOH statement said.
The FDA's response to Ladapo in December rebutted each of his concerns, warning that vaccine "misinformation and disinformation" would result in fewer people getting vaccinated, which contributes to the "continued death and serious illness toll of COVID-19."
COVID-19 rates in Florida
In Florida, cases for August dropped from last year's numbers, with 62,038 reported cases this year compared to 91,941 in August 2023. Both numbers are almost certainly low as many people self-test at home and some may have it and never test at all.
Deaths from COVID were on par with last year, however, with 828 last August compared to 877 in 2023. The average death total for the four months prior this year was 265.
So far 8.2 million Floridians have been infected with COVID-19 at least once, according to FDOH data, and 97,250 have died.
Ladapo says vaccine won't protect against new strains despite FDA assurances
Along with a lengthy list of concerns over the effectiveness and health risks of mRNA vaccines and boosters, the FDOH statement warned that "this booster does not protect against the currently dominant strain, accounting for approximately 37% of infections in the United States" and said that the vaccine was approved without specific trials in humans.
The FDA said in a release that the updated vaccines granted an emergency use authorization for distribution this fall were designed to target the KP.2 strain but also "more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death."
As of the latest CDC's Nowcast data tracker, which displays COVID-19 estimates and projections for two-week periods, the Omicron KP.3.1.1 variant accounted for 52.7% of positive infections between Sept. 1 and Sept. 14, followed by KP.2.3 at 12.2%, with LB.1 at 10.9% and KP.3 at 10.6%.
“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
The Centers for Disease Control and Prevention (CDC) recommends that everyone ages 6 months and older receive an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 for this fall and winter season.
Ladapo's history of COVID vaccine criticism
September 2021: Within a day of being hired, Ladapo signed new rules allowing parents to decide if children exposed to COVID could go to school anyway, eliminating the previous requirement for exposed students to quarantine off campus for at least four days.
October 2021: Ladapo appeared at DeSantis' side in public appearances, supporting the governor's views on blocking vaccine and mask mandates and accusing the public health community of fearmongering. Critics accused him of spreading misinformation that led to people being hesitant or afraid of vaccines. A firestorm of criticism erupted after Ladapo refused to wear a mask around Democratic state Sen. Tina Polsky even after she told him she had a serious medical condition (later confirmed as breast cancer) and was at a higher risk for serious complications from COVID.
December 2021: The Florida Department of Health rejected a complaint about Ladapo that said he violated state medical laws by publicly casting doubts about COVID vaccines and promoting unproven treatments.
January 2022: At a press conference, DeSantis and Ladapo told Floridians who weren't showing symptoms not to get tested. “If you don’t have symptoms, you are not a case," Ladapo said, in defiance of CDC and virologist recommendations.
June 2022: DeSantis and the FDOH, under Ladapo, refused to pre-order COVID-19 vaccines for children under five when they became available, the only U.S. state to do so, citing the lack of need and the risks. Ladapo appeared before Congress to defend the state's decision and said the state didn't recommend vaccines for children under 18.
October 2022: Ladapo urged men younger than 40 to avoid the Pfizer and Moderna mRNA vaccine and booster shots because of the "abnormally high risk of cardiac-related death among men in this age group," citing an anonymous non-peer-reviewed analysis from the FDOH. The move prompted a backlash from doctors, researchers and the federal government. At the time, Florida was leading the country in COVID deaths for the third month in a row.
January 2023: A task force of University of Florida medical school doctors concluded that the FDOH recommendation against COVID vaccines for young men was of “highly questionable merit" and that Ladapo cherry-picked data to support his stance. Politico went further and, after examining different drafts of the analysis, reported that Ladapo had personally changed the study to remove data that contradicted his views. Ladapo has denied this.
March 2023: In response to a letter from Ladapo demanding answers based on his own research on vaccine safety, the FDA and CDC asked him to stop disproportionally focusing on the small number of adverse effects in the studies of 13 billion COVID shots given around the world while ignoring the number of people the vaccines have saved.
April 2023: The FDOH under Ladapo stopped reporting COVID infections and deaths to the federal government
September 2023: Ladapo recommended against anyone under the age of 65 getting the new COVID-19 vaccine booster the FDA approved to combat new, more infectious variants, directly contradicting CDC guidance. He claimed that the mRNA boosters altered human DNA, which the CDC and multiple studies have said is false.
November 2023: After a two-year battle over COVID public records, the FDOH under Ladapo settled a lawsuit about withholding COVID data and released information spanning the entire duration of the pandemic on the state's FLHealthCHARTS.gov site. However, the agency also stopped providing cumulative totals, percentages, new case positivity, data on booster doses and overviews that made it easier to see trends.
January 2024: Ladapo made headlines again by "calling for a halt to the use of mRNA COVID-19 vaccines" because he said he didn't receive an adequate response from the FDA about the safety of vaccines. Meanwhile, Florida was seeing a spike in new COVID cases and hospitalizations.