Fda Asks Court To Delay Full Release Of Documents On Pfizer Covid Biologic For 55 Years
In response to a Freedom of Information Act lawsuit filed on Sept. 16, 2021 against the U.S. Food and Drug Administration by a medical transparency group of more than 30 physicians, professors and scientists from various universities in the United States, the FDA has asked a federal judge to delay the full release of all documents in the agencys possession related to its Aug. 3, 2021 licensing of the Pfizer-BioNTech COVID-19 Vaccine until the year 2076.1234
The lawsuit, filed in U.S. District Court for the Northern District of Texas by the nonprofit Public Health and Medical Professionals for Transparency , was prompted after the FDA denied a request by the PHMPT to expedite the release of the documents. The FDA and the PHMPT were unable to agree on a disclosure schedule.1235
Attorneys for the U.S. Department of Justice representing the FDA propose that the FDA be allowed to release 500 pages per month on a rolling basis.23 DOJ attorneys wrote:
By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer requesters requests are being fulfilled.2
But attorney Aaron Siri, whose firm, Siri & Glimstad LLP of New York, is representing PHMPT in the lawsuit, notes:
Enhancing Uptake Of Current Vaccines
Although coverage with the initial package of routine infant vaccines is now as high in many low- and middle-income countries as it is in the industrialized world , pockets remain where this is not the case, often among the poorest and most vulnerable sections of the community. Many further lives could be saved by reaching these populations with routine EPI vaccines such as measles. Finding better ways of reaching these groups, who account for an increasing proportion of child morbidity and mortality in many developing countries, with appropriate health interventions is likely to be a key target of the post-2015 development goals. Methods being explored include gaining a better understanding of why these communities or individuals are resistant to vaccination, making vaccination more accessible through home visits and using mobile phone technologies for reminders and data collection. However, more operational research is needed on how to help these vulnerable groups .
Total Direct Costs Of Vaccination Throughout Life Are Comparable To Or Lower Than Those For Other Preventive Measures
Within health care expenditures, prevention spendings represent a small percentage of total expenditures in Europe . In France, total expenditure on vaccines represented an estimated 0.3% of total health care expenditure in 2013 .
A recent study estimated that the lifelong costs per individual vaccinated in full compliance with national recommendations in France ranged from 524 to 1,379 in 2014, covering 12 to 16 diseases, respectively, and from 865 to 3,313 when including administration costs . It was estimated that lifelong vaccine costs were 4 to 10 times lower than costs of statins in the treatment of hypertension 7 to 14 times lower than the costs for DPP-4 inhibitors in the treatment of type 2 diabetes and 6 to 13 times lower than costs for antithrombotic medication in the prevention of recurrent stroke. Hence, prevention through vaccination requires low levels of investment relative to the substantial benefits that can be obtained.
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Us Investment In Covid
The FDA has authorized two vaccines for emergency use one developed by Pfizer/BioNTech and another by Moderna in partnership with the National Institutes of Health that are being distributed to states to be administeredto people across the country. Both of these mRNA-based vaccines have shown high rates of efficacy each about 95% against COVID-19 in clinical trials. Operation Warp Speed is also supporting work on four other vaccine candidates developed by AstraZeneca,Johnson& Johnson, , and Sanofi/GlaxoSmithKline.
Cases Of Measles In The United States
In 2019, the U.S. experienced the worst measles outbreak in three decades, with more than 1,200 cases reported by the CDC in 22 different locations around the country. Worldwide, more than 200,000 people died from this vaccine-preventable disease in 2019, with a 500% rise in measles cases compared to three years earlier.
Early in the coronavirus pandemic there were indications that child immunization rates for routine vaccinations were decreasing. In response, doctors and nurses have implemented safety measures in their offices and tried to reassure parents about the safety protocols in place to protect against the spread of the coronavirus. Public health officials are hopeful that enough children will catch-up on their routine immunizations to help protect communities and prevent outbreaks of vaccine-preventable diseases in the future. In August, the Department of Health and Human Services took an additional step toward this goal, allowing pharmacists and registered pharmacy interns to administer routine childhood vaccines during the COVID-19 public health emergency.
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How Successful Are Vaccines
Vaccination is the most effective preventative measure against infectious diseases. Most vaccine-preventable illnesses are highly contagious, spread quickly and can cause severe complications which may impact on our quality of life.
Vaccines give us immunity without us getting sick. They also protect vulnerable people in our community who cannot be immunised such as very young children or those who are too sick.
When enough people in the community are vaccinated, the spread of a disease slows down or stops completely. So as long as enough people are vaccinated, diseases will not spread. We call this herd immunity or community immunity. The percentage of people who need to be immune in order to achieve herd immunity varies with each disease. For example:
- Measles, mumps, rubella 95 out of every 100 people vaccinated will be completely immune.
- Whooping cough about 85 out of every 100 people vaccinated will be completely immune.
Careers In Community Health
Public health workers are engaged in a broad scope of activities, including research, education, program development, program management, medical care, and charitable aid. Roles can range from leadership positions to frontline caregivers. Professionals seeking careers in community health might work in medical, educational, government, corporate, or nonprofit settings.
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Why Community Health Is Important For Public Health
A young first-time mother receives at-home nurse visits as part of a community outreach program. A weekly clinic targeting high diabetes rates helps a struggling man with diabetes gain nutritional control and reduce symptoms. These success stories illustrate how improving quality of life in communities is an essential part of public health.
The public health workers goal in community-focused care is to enhance healthcare services and patient outcomes in targeted populations. By applying public health theory on a local, personalized level, community health providers can cater services to a specific demographic and bring a sense of wellness to communities that would otherwise lack proper access to care.
Community health programs address disparities by ensuring equitable access to health resources. Such disparities include living in an isolated rural area with limited healthcare providers or being unable to afford health insurance. Community health centers often serve as the primary care provider in communities where health equity is limited by socioeconomic factors.
Those seeking to apply public health principles to address a local populations needs must understand the areas unique characteristics. This allows them to interact dynamically with community members and create a lasting positive impact on the population.
Effective Messaging Is Critical
The study concludes that parents who vaccinate appear to have weaker belief systems than anti-vaccine groups, and are therefore potentially susceptible to change. Effective messaging to this group is critical and if trust in public health falters, many who currently support vaccination may re-evaluate their positions, he said.
While exemption rates appear to be low among school age children, there is an information vacuum about pre-school children, since Canada and Ontario lack a vaccine registry system. Parents concerns cant be effectively addressed without accurate information, Wilson stresses.
A 2006 study by the Institute for Clinical Evaluative Sciences estimated, based on doctors billings, that only 75 per cent of two year olds in Torontopre-schoolers not covered by vaccination legislation unless registered in day care or nurseries were up to date for age-appropriate vaccines and four percent had received no vaccines.
Natasha Crowcroft, chief of communicable diseases at Ontario Public Health, says public health officials need to be really creativeno one has the perfect answerabout how to sustain confidence in the system when things are going well.
Crowcroft was the guest on a CBC radio phone-in show about vaccination last month, and the majority of callers were opposed to vaccination. Parents, for example, argued that keeping children healthy with good nutrition is the best defence against illness.
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Reducing The Societal And Caregiver Burden
It is increasingly acknowledged that the costs of disease not only fall on the individual patient but also on caregivers including family, friends, communities, and the wider society. It is from this perspective that vaccination against preventable infectious diseases warrants a broader societal value. As mentioned previously, varicella disease in children incurs considerable indirect costs as a result of parental absenteeism and loss of productivity . For example, the total indirect costs of varicella over a 50-year period in Italy were estimated to be 2,280 million . In Germany, the total annual costs of varicella for payers was estimated to be 78 million, the largest portion of which was due to the significant work loss costs incurred by parents caring for their sick children. For the society, the total annual costs were estimated to be 187.5 million, 82% of which corresponded to indirect costs .
The Cost Of A Vpd Outbreak: Measles
The U.S. recently experienced an increase in measlesa highly contagious disease spread through the air when an infected person coughs or sneezes. Measles is so contagious that if one person is infected, nine out of 10 people with whom they have close contact who are not immune to measles will become infected. Before the measles vaccine was introduced in 1963, there were about three to four million cases of measles in the U.S. alone essentially every child had the disease by the time they were 15 years of age. About 1,000 people suffered disabilities from the disease, such as deafness or permanent brain damage from encephalitis, and approximately 450 people died each year from measles. By 2000, naturally occurring cases of measles had been eliminated. During 20002008, there were approximately 50 measles cases each year that had come from other countries where measles was still endemic, with increasing numbers of importations into the U.S. as a result of increases in measles cases in countries visited by U.S. travelers, including some parts of Europe, Asia, the Pacific, and Africa.
A public health response to measles in Salt Lake County, Utah, from March to April 2011 involved nine measles cases, but required officials to trace thousands of contacts, review immunization records of hospital workers and teachers, give post-exposure prophylaxis to nearly 400 people, and isolate 200 others. The estimated cost of this response was $300,000.
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What Are Your Challenges
Overall, its simplifying the amazing knowledge and information at the technical and scientific level, says Dubuc. When we create a guide or other product, the experts see the intricacies in every statement. Our challenge is to take their great work and explain it so your neighbour can understand it while respecting the level of accuracy the experts want. The messages we create also need to help healthcare providers talk to their patients. So we push the experts to answer the why behind the what because patients ask questions they want to know what evidence is behind the advice.
Reduction In Treatment Prescription
Preventing diseases through vaccination also leads to a reduction in the consumption of medications. For example, medication use is high in children who have influenza in addition to antipyretics and other symptomatic treatments, antibiotics were prescribed to 43% of children in primary care-based studies .
Vaccines that can prevent diseases, such as influenza, pneumococcal diseases, and shingles, in the elderly are likely to reduce not only the costs associated with medication consumption but also the costs associated with their side-effects. For example, a Dutch study of 84 patients with postherpetic neuralgia reported that 89% of patients took prescription medications such as antidepressants, opioids, various analgesics as well as antiepileptic medicines . The elderly are highly susceptible to side-effects from medications, partly because they generally take more than one medication, and there is often no dose adjustment . Polypharmacy is known to be associated with negative health outcomes and a major cause of drug interactions and safety problems in this age group .
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How To Get The Vaccine
To receive the vaccine your child must be born in 2016 or earlier and not have any COVID-like symptoms.
In Ontario, the recommended time between the first and second dose of the vaccine is at least 8 weeks.
Children 5 to 11 years old
As of November 23, at 8 a.m. appointments can be booked for children 5 to 11 years old through Ontario’s vaccine booking system or by calling 1-833-943-3900 .
Walk-ins are not available for this age group.
Children born in 2009 or earlier
First and second doses are offered at different types of clinics, including Peel Public Health vaccine clinics, pop-up clinics, school vaccine clinics, pharmacies, doctorâs offices, and walk-in clinics.
Access get the vaccine for booking and location details.
Providing consent for the COVID-19 vaccine
Peel Public Health requires informed consent for anyone receiving the COVID-19 vaccine, consistent with legal allowances in the Health Care Consent Act.
Children 12 years or older can give informed consent provided they understand the treatment, why it is being recommended, and the risks and benefits of accepting or refusing to be vaccinated.
Reduction Of Pressure On Healthcare Systems
Research highlights the importance of hospitals being able to cope in the event of unexpectedly large demands, for example, from an epidemic outbreak of an infectious disease such as swine influenza . This results in capacity being held back in preparation for such events, which represents around 5% of the total cost of an emergency admission .
In addition to reducing healthcare costs, vaccination can help to strengthen the sustainability of healthcare systems, especially at the hospital level. For example, vaccines such as influenza and rotavirus vaccines can contribute to a reduction in hospital admissions, thereby enabling a better allocation of resources.
The pressure on resources induced by RVGE or influenza for hospitals and emergency departments and the resultant impact on budgets and the ability to deliver care may be underestimated. While disease-related hospitalisation costs are usually included in economic studies, the impact of rotavirus infections on healthcare systems and hospital workload and organisation due to excess nosocomial infections, increased hospital resources, and hospital disruption are not usually considered.
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Enhancing Value Of Vaccination Through Indirect Protection
One of the unique properties of vaccination and sometimes even potentially one of the main goals is its ability to confer indirect protection through a herd effect to unvaccinated individuals and groups . Vaccination of a fraction of a population reduces the number of those susceptible to infection within the population and, thus, the probability of infection that can result in disease is also reduced. Hence, vaccination can control the transmission of the causative agent and limit the associated infection both directly and indirectly. This benefit is increasingly important given today’s globalisation and nomadic cross-border population movements and emphasises the broader value of vaccination as an essential preventative healthcare intervention.
What Diseases Have Vaccines Eradicated
When considering the benefits of vaccines, it is important to answer these questions
- How many lives are saved by vaccines?
- Why is vaccination important, and what benefits does it offer?
- What diseases have vaccinations eradicated, and how many lives saved by vaccines?
- How many lives have been saved by vaccines worldwide?
- How many diseases eradicated by vaccine have reappeared, if any?
The reality is, there are diseases eradicated by vaccine by public health initiatives that highly recommend a vaccination. For instance, smallpox and rinderpest have been eradicated with the use of vaccines given preventatively and therapeutically, as necessary.
There are many examples of diseases that have been almost eradicated by vaccines
- Measles
- Bacterial Influenza, among others.
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What Makes You Feel Good About The Work You Do
The answer to this question depends on who from the IPE team you ask.
- After a lot of hard work to create a product in a way thats useful for Canadians, to hold it in my hands and know that as a practicing public health nurse a short while ago, I could have used it to help me in conversations with a patient, thats when I feel good.
- At a recent conference when the CPHO spoke about our Parents Guide to Immunization during the speech, that was a significant moment for our group. Christina Comeau
- When I go to my doctors office and see our latest products available for patients, its satisfying. Carolyn Lacaille
Who Does Community Immunity Protect
Community immunity protects everyone. But its especially important because some people cant get vaccinated for certain diseases such as people with some serious allergies and those with weakened or failing immune systems .
Community immunity is also important for the very small group of people who dont have a strong immune response from vaccines.
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