USPSTF Recommendations: Role of Aspirin to Reduce CVD Risk
The 2022 USPSTF recommendations, based on the most current literature, provide updated guidance regarding the use of aspirin to reduce risk for cardiovascular disease (CVD). CVD is responsible for approximately 25% of deaths in the US and is currently the leading cause of mortality.
Evaluation of CVD risks
Effectiveness of aspirin to reduce the risk of CVD events (myocardial infarction and stroke) | Cardiovascular mortality | All-cause mortality in persons without a history of CVD
Harms: Primary focus on bleeding
GI bleeding | Intracranial hemorrhage | Hemorrhagic stroke
Adults ≥40 years
No signs or symptoms of CVD or known CVD (including history of myocardial infarction or stroke)
Not at increased risk for bleeding
Ages 40 to 59 years and ≥10-year CVD Risk
Decision to initiate low-dose aspirin use for the primary prevention of CVD should be an individual one
Evidence indicates that the net benefit of aspirin use in this group is small
Persons who are not at increased risk for bleeding and are willing to take low-dose aspirin daily are more likely to benefit
The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences
There is at least moderate certainty that the net benefit is small
Offer or provide this service for selected patients depending on individual circumstances
The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD
The USPSTF recommends against the service
There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits
Discourage the use of this service
CVD risk assessment tool
The American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equations
May be used to estimate 10-year risk of CVD | Only validated US-based CVD risk prediction tool | Age is a main driver of risk for CVD
Risks using the ACC/AHA tool are only estimates
Bleeding risk is increased with the following
Increasing age | Male sex | Diabetes | GI history (e.g., peptic ulcer disease) | Liver disease | Smoking | Elevated BP | Certain medications (e.g., NSAIDs)
Recommendations of Others (see ‘Learn More – Primary Sources’)
The ACC/AHA recommends that low-dose aspirin use (75 to 100 mg/d) might be considered for the primary prevention of atherosclerotic CVD among select adults aged 40 to 70 years at higher CVD risk but not at increased risk of bleeding
Low-dose aspirin use is not recommended on a routine basis for primary prevention of CVD in adults >70 years or among adults of any age who are at increased risk of bleeding
Benefits of aspirin for CVD prevention appear similar for a low dose (≤100 mg/d) and for all doses that have been studied in CVD prevention trials (50 to 500 mg/d)
The USPSTF states that “A pragmatic approach would be to use 81 mg/d, which is the most commonly prescribed dose in the US”
Compared with interpregnancy intervals of 18 to 23 months
< 6 months associated with increased risks of preterm birth, low birth weight, and small for gestational age
6 to 17 months and longer than 59 months were also associated with a significantly greater risk for the 3 adverse perinatal outcomes
Short interpregnancy intervals are associated with reduced VBAC success
Take into account personal/mitigating circumstances such as age, fecundity, economic and social support systems
Provide full range of contraceptive options being sensitive to context and history of marginalized populations on this subject
Insurance coverage and Policy Considerations
ACOG endorses paid parental leave for 6 weeks, including full benefits and 100% pay and in addition
Insurance coverage policies should be aligned to support this tailored approach to “fourth trimester” care.
Optimizing care and support for postpartum families will require policy changes. Changes in the scope of postpartum care should be facilitated by reimbursement policies that support postpartum care as an ongoing process, rather than an isolated visit.
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Discuss how OR set-up affects success in a gynecologic laparoscopy case
Discuss surgical strategies utilizing the retroperitoneum to accomplish difficult pelvic surgery
Review alternate techniques for control of the uterine blood supply during hysterectomy
Review techniques to successfully and safely address the difficult bladder flap
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high-quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The faculty reported the following relevant financial relationships with ineligible entities related to the educational content of this CE activity:
Mallory A. Stuparich, MD, FACOG has nothing to disclose
Planners & Managers The PIM and ObGProject planners and others have nothing to disclose.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
ACOG Addresses Use of Oxygen for Fetal Indications During Labor
ACOG has released a Practice Advisory regarding the use of oxygen supplementation in the setting of category II or III fetal heart tracings. The Advisory supplements the Practice Bulletin regarding intrapartum fetal heart rate monitoring and recommends against supplemental oxygen. The Advisory is based on recent literature, and focuses on a key paper by Raghuraman et al.
Maternal Oxygen Supplementation Compared With Room Air for Intrauterine Resuscitation (JAMA Pediatrics, 2021)
The research team assessed whether there was an association between umbilical artery (UA) gas measures and neonatal outcomes with peripartum maternal oxygen administration vs room air
Systematic review and meta-analysis
Study inclusion criteria
Studies that compared oxygen with room air at the time of scheduled cesarean delivery or labor
Participants were patients with singleton, nonanomalous pregnancies
Umbilical artery (UA) pH
UA pH <7.2 | UA PaO2 | UA base excess | Apgar scores (1 and 5 min) | NICU
Supplemental oxygen therapy at delivery was not associated with improvement in umbilical artery pH or other neonatal outcomes
An associated editorial to the above study concludes
While maternal oxygen administration to the normally oxygenated mother in labor is likely as innocuous as it is useless, concern for the practice of evidence-based medicine would seem to suggest that recommendations for its use in 2 million to 3 million women annually may be inappropriate
The ACOG Practice Advisory states
Based on this body of research, routine use of oxygen supplementation in individuals with normal oxygen saturation is not recommended for fetal intrauterine resuscitation
Physicians and Patients Take On – and Win – the “Post Polypectomy Surprise” Billing Controversy
Organizing efforts led by physicians and advocacy groups have resulted in a new law removing a problematic barrier to colon cancer screening, and a big win for patients.
Current Colorectal Cancer Screening Guidelines
Colorectal cancer (CRC) is still a major public health issue but is largely preventable. The USPSTF currently recommends
Asymptomatic adults ≥45 years
50 to 75 years (A recommendation)
45 to 49 years (B recommendation)
Selectively offer screening in adults 76 to 85 years (C recommendation)
Guidance refers to individuals who are at average risk of CRC
No family history of known genetic disorders predisposing to high lifetime risk of CRC (e.g., Lynch syndrome or familial adenomatous polyposis)
No personal history of IBD, previous adenomatous polyp, or previous CRC
Grade A and B recommendations take on special importance because they specify that doctors and other healthcare professionals should ‘offer to provide this service’
What’s the Good News Regarding Grade A and B USPSTF Recommendations?
The Affordable Care Act (ACA) addresses reimbursement for preventative care with a focus on key professional recommendations including those of USPSTF. This means that health insurance plans must provide coverage resulting in no out-of-pocket payments for patients.
What Went Wrong?
Even prior to the ACA, there have been efforts to reduce the financial burdens associated with colorectal cancer screening. Starting in 2002, the Screen for Life Act sought to increase reimbursement for colorectal cancer screening and diagnostic tests and waived the deductible for colorectal cancer screening tests. With the 2010 Affordable Care Act, financial barriers to CRC screening have slowly disappeared. However, an unintended quirk in the law brought sticker shock to asymptomatic patients if a worrisome polyp was actually removed during a colonoscopy screening procedure. Even though the polypectomy would be considered standard of care (and considered a positive outcome of the screening procedure), the procedure was now considered therapeutic. Known as the ‘post polypectomy surprise’, the waiver of cost-sharing goes away and patients would have unexpected bills. This surprise expense was viewed as barrier to screening aside from being unfair to patients and physicians alike who are simply following best practices.
What Happened in January 2022?
The push back against the ‘post polypectomy surprise’ is an excellent example of how physicians can organize, along with the support of other advocacy groups, to address and reverse a problematic barrier to care. Once the billing issue became clear following the passage of the ACA, advocacy led to the passage of ‘The Removing Barriers to Colorectal Cancer Screening Act (S. 668; HR 1570)’. Thanks to these efforts, over the next eight years, starting on January 1, 2022, the Medicare beneficiary coinsurance that stands at 20% for when a polyp or other growth is found and removed as part of a screening colonoscopy or screening flexible sigmoidoscopy will be phased out to zero. The eight-year phase arises from the pay-as-you-go rule, also known as PAYGO. It requires to pay for such legislation by reducing other entitlement spending or increasing other revenues with the goal of limiting any expansion of the budget deficit.
Physician societies and organizations spent years of effort and resources to remove this barrier to care. Enactment of the ACA is associated with a significant 23% reduction in colorectal cancer cases and deaths. Dr. David Greenwald, President of the American College of Gastroenterology stated the following which should be a clarion call to physicians of all specialties about taking a stand on behalf of our patients
On behalf of the American College of Gastroenterology, I want to thank Congress for including the Removing Barriers to Colorectal Cancer Screening Act (S. 668; HR 1570) in the larger spending and COVID-19 relief packages today. This legislation is long overdue and will help increase colorectal cancer screening rates in the Medicare population. Thank you, Rep. Donald Payne, Jr. (D-NJ), Sen. Sherrod Brown (D-OH), and all current and former members of the U.S. Congress for championing this important bipartisan issue throughout the years. ACG is grateful to partner with many patient advocacy groups and professional societies, who have all joined together to get this passed through Congress
Colorectal cancer is still a major public health issue, yet still is largely preventable. Over 50,000 Americans are estimated to die from colorectal cancer this year. It does not take a pause due to COVID-19, or any other public health crisis. Thus, it is important for policy makers to do everything we can do to incentivize and increase colorectal cancer screening rates in the Medicare population
External Cephalic Version: Clinical Recommendations and Factors for Success
Breech occurs in approximately 3 to 4% of term pregnancies. The goal of External Cephalic Version (ECV) is to increase the proportion of vertex presentation at term and to decrease the risk of cesarean delivery secondary to breech presentation. Between 20 to 30% of eligible women are not offered this procedure
Fetal presentation should be assessed beginning at 36w0d
Preterm ECV has been linked with higher rates of initial success, but increased risk of preterm birth and higher rates of reversion
If spontaneous version is going to occur it is likely to have occurred by then
Risk of spontaneous reversion is decreased
ECV during delivery admission vs breech presentation has a 65% success rate and is associated with
Lower cesarean delivery rate
Lower likelihood of hospital stay >7 days
Limited information in women with preexisting uterine scar or during early stages of labor
ECV is contraindicated when vaginal delivery is not clinically appropriate
There are no absolute or relative contraindications
Evaluate each case individually
Fewer cesarean deliveries
Lower odds of
Endometritis | Sepsis | Hospital stay > 7 days
Lower hospital charges
No differences for
Low Apgar | Low umbilical vein pH | Neonatal death
Risks and Adverse effects
Most common risk is fetal heart rate changes
Typically, heart rate stabilizes when procedure is discontinued
Overall serious adverse effects are very low with rates <1%
Consider depression screen with PHQ-2, PHQ-9 if the 2 values screen is positive
Other signs / symptoms
Loss of appetite
Abnormal uterine bleeding
Breast, ovarian, colon cancers
Other family members with similar pain syndromes
Gait, affect, positioning
Abdominal muscles (pain when palpating in presence of flexed abdominal muscles is indicative of myofascial etiology [Carnett’s sign])
Abd: Bowel sounds | Palpation in standing and reclining for pain, hernia or mass
GU: Suprapubic exam | Vulvar exam | Speculum and bimanual pelvic exam (typically start with no hand on the abdomen hand to assess for uterine / adnexal tenderness) | Pelvic floor exam for tension | Trigger points
Further Diagnostic Workup
CBC | Metabolic panel | Urinalysis | STI screen
Pelvic ultrasound with transvaginal component is sensitive for GYN etiology
Abd/Pelvic CT with contrast may better describe bowel and intraperitoneal etiologies
Surgical evaluation: Laparoscopy
Histology of lesions removed at surgery remains a method for definitive diagnosis of endometriosis (even with negative ultrasound report)
May detect ovarian or fallopian tube torsion, with treatment potentially possible during the procedure
DIFFERENTIAL DIAGNOSIS FOR ABDOMINAL ABD/PELVIC PAIN
Typically presents with pain around menses, can progress to chronic, constant pain; confirmation via laparoscopy and/or biopsy
Typically presents with menses-related pain, severe cramping with menses | While adenomyosis is defined histologically as “the presence of ectopic endometrial tissue (endometrial stroma and glands) within the myometrium” new imaging techniques such as ultrasound or MRI can aid in detection
Note: Both endometriosis and adenomyosis may be detected on ultrasound, but can also exist in the setting of a negative scan | Both may respond to combined OCP, progesterone-only hormonal treatments, or GnRH agonists | Surgical evaluation for endometriosis may be undertaken for diagnosis and treatment
Usually in setting of past pelvic inflammatory disease (PID) or endometriosis
Ovarian or Fallopian tube torsion
Absence of flow to adnexal structures is indicative
Note: periodic torsion can present as cyclic pain and show normal flow on ultrasound
Surgical evaluation may be necessary if these diagnoses are suspected
Levator Ani / Pelvic Floor pain
On examination, pelvic floor muscles are often tight and tender: associated with dyspareunia
Assessed on exam with careful palpation | Myofascial trigger points usually present
Urinalysis looking for blood, WBC and infection | An ultrasound or non-contrast CT may help find kidney stones | A post void residual volume can be used to exclude retention due to outlet obstruction or neurologic issues | Cystoscopy may be done to look for other etiologies of bladder pain, especially if there is hematuria on microscopy | Cystoscopy may not be needed to make the diagnosis of IC
THE WRAP UP: NEGATIVE WORK-UP AND PERSISTENT PAIN
Consider Acute Hepatic Porphyria (AHP)
Clinical presentation following a negative work-up is consistent with Acute Hepatic Porphyria (AHP) and therefore further diagnostic evaluation may include a random (spot) urine for porphobilinogen (PBG), δ‐aminolevulinic acid (ALA) and porphyrins
There are four types of AHP: acute intermittent porphyria (AIP) is the most common; variegate porphyria (VP), hereditary coproporphyria (HCP) and ALAD-deficient porphyria (ADP) are the other types
Timely diagnosis is critical because AHP may mimic other diseases/conditions and lead to negative outcomes, including potentially unnecessary treatments, surgeries and hospitalizations
65% of AHP patients with recurrent attacks reported chronic symptoms between attacks
Risk for potential long-term complications: Elevated risk for primary liver cancer (hepatocellular carcinoma) | Chronic renal disease and hypertension | Lasting neurologic and mental health issues
Progestins, among other drugs often used in women’s health, could exacerbate symptoms and incite acute attacks of abdominal pain
Management and treatment options are available
What Should Tip You Off That This May Be AHP?
While AHP can be difficult to diagnose due to the non-specific symptoms and overlap with other more common conditions, clues are present in this case. For educational purposes, the patient in this case had numerous triggers and clues leading to porphyria, but not all may be present in all cases.
Intermittent cyclical severe pain leading to multiple visits associated with psychological symptoms such as anxiety
Worsening or triggering of symptoms occurring with certain medications, such as sulfonamides
Red/brown urine can be observed if urine is exposed to light, especially during a painful attack (can be mistaken for or masked by hematuria)
Usually begins in women at the onset of puberty, typically effects women in their second to fourth decades of life
More predominant in women as hormones associated with the menstrual cycle can precipitate an attack
Attacks can be unpredictable, but cyclical attacks in women often begin during the luteal phase of the menstrual cycle when progesterone levels are elevated
Progesterone-containing medications have also been associated with attacks
Often symptoms of AHP are nonspecific and therefore delays in diagnosis and numerous misdiagnoses are common
General Features That May Point to Porphyria
Note: AHP can present in variable ways | Patients may not have all of these symptoms
Abdominal pain that is severe, unremitting and diffuse
Usually the hallmark sign of an attack
Pain may be described as cramping; may also present with pain in the chest, neck, thighs, arms and back
Liver transplantation is rare and limited to severely affected patients
Pregnancy and AHP
Hormonal changes may worsen AHP in some individuals
Some fertility treatments have also been associated with triggering acute attacks
Autosomal Dominant Inheritance Pattern with low penetrance: 50% chance with each pregnancy of passing mutation on to offspring
The educational materials, including the hypothetical case study, are sponsored by Alnylam Pharmaceuticals. They are not intended to replace a healthcare professional’s independent clinical judgment. The “Learn More Primary Sources” below are provided for reference. Alnylam Pharmaceuticals does not endorse the “Learn More” sites below and is not responsible for their content.
Wildflower Health today announced a partnership with The ObG Project, propelling efforts by both companies to re-imagine maternal health by powering virtual and value-based OB care.
Over the past decade, Wildflower has worked with hundreds of hospitals and health systems to align payers and clinical care teams around women and their families. The company uses a combination of software, hardware and humanware to improve patient outcomes and lower medical costs. The ObG Project is the leading professional information resource for women’s health and primary care clinicians. Established for healthcare professionals by healthcare professionals, it offers clinicians a single, efficient and unbiased educational hub.
Wildflower is working with The ObG Project to strengthen its platform’s capabilities for risk identification and patient stratification, as well as helping its virtual advocates expertly identify and connect high-risk patients with appropriate clinical resources. Wildflower will also make The ObG Project’s premium services available to its clinical partners, enabling robust professional education and clinical guideline alerts to help busy clinicians keep current.
“One of the reasons we are so excited about Wildflower is that they have solved for the missing piece, which is turning data into actionable information to support the clinician,” said Sue Gross, MD, CEO of The ObG Project. “It’s important to make sure clinicians are a central part of the story, however most of the solutions in the market today have not done a very good job of addressing the provider’s needs. With Wildflower, there is now a venue for clinicians to quickly and easily access vital information to help them care for their patients.”
Wildflower’s platform integrates social, demographic and clinical factors for a holistic view of each patient. Based on risk assessment surveys and data collected from app usage and connected devices, Wildflower establishes an initial risk stratification for each individual. From that point onward, patients undergo longitudinal monitoring and risk assessment.
Advocates are supported with a playbook that details relevant medical information and protocols for escalation. Leveraging risk assessment data from the Wildflower platform and a portal powered by The ObG Project content and resources, Wildflower’s advocates synthesize information and connect to partner OB professionals with appropriate patient referrals and escalations. OB professionals can leverage The ObG Project literature to inform and support evidence-based provider decisions.
Leah Sparks, CEO & Founder of Wildflower Health commented: “To fully reach the potential of the value-based care models we are enabling, we have to accurately assess risk, empower patients for self-management, support evidence-based care decisions by our partner providers, and escalate individuals to proper care in a timely fashion. By teaming up with The ObG Project, we have bolstered our ability to deliver on all of these key requirements, which are all equally important to transform healthcare for women while shrinking the cost of care.”
“When health for women improves, the health of society improves,” added Dr Gross. “Wildflower and The ObG Project are aligned on this goal and incredibly excited to be partnering to support both providers and patients on the journey to value-based care.”
About The ObG Project – For physicians, by physicians
The ObG Project is a digital media company created to deliver guideline-based medical information to physicians and other healthcare professionals. Designed to address how today’s clinicians want to receive information, our digital platforms are easy to access, quick to read, mobile-friendly, and focused on how this information can benefit their patients. We create content and design everything from social media campaigns and digital platforms to full communication infrastructures. We understand how to engage busy physicians because we are physicians: since our founding in 2016, physicians from around the world have visited ObGproject.com generating millions of page views of The ObG Project’s physician-focused content. For more information, check our website at ObGProject.com or contact us at firstname.lastname@example.org.
Wildflower connects women and families to better care by breaking down silos among providers, payers and best-in-class partners. Our digital platform and virtual patient advocates engage the Chief Health Officer of the home (aka mom) by delivering personalized experiences that simplify the healthcare journey for families. Our model also fuels the transition from fee-for-service to value based care. Empowering women. Collapsing silos. Rewarding value. This is a smarter way to care. http://www.wildflowerhealth.com
What is DNA@ObG?
Q:What is DNA@ObG?
A: DNA@ObG is a resource for the latest genetic information in women’s health to share with your patients. It is clearly written, references our professional organizations, and free from commercial bias. DNA@ObG was created for and by healthcare professionals to support discussions with your patients about topics such as genetic screening versus diagnostic testing, common ultrasound findings, cancer genetics, and much more.
Q:Who can access DNA@ObG?
A: ObGFirst® Members can access DNA@ObG at no additional cost – now included with your subscription!
Q: Where will I find DNA@ObG?
A: You (ObGFirst Members only) can access DNA@ObG from The ObG Project Homepage. To share information with patients, simply save and/or print a copy by using the PDF icon that appears at the top and the bottom of every entry.
If you tap/click on the icon, a PDF will be generated that you can save and share the page as a PDF file.
Q: Is DNA@ObG being updated or is this a ‘one and done’?
A: The team at ObG makes every effort to update the site as new guidelines become available.
Q: What if I just want to send my patient to the site?
A: Contact us here and we will personally help you get this set up and provide you with a special code just for your patients.
Q: I have an ObG subscription, but when I put in my username and passcode, I am not able to get into DNA@ObG. What’s the problem?
A: If you have an ObG subscription, but are being blocked from the site, it is likely because you have a subscription to our free weekly eNewsletter, The ObG Insider™, or to our ObG L&D eBook. Only subscribers to ObGFirst can access DNA@ObG for free. In addition to DNA@ObG, our ObGFirst membership includes:
Prenatal ultrasound atlas
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The DNA@ObG entries are meant for healthcare providers to share with patients as an educational tool. They are not intended as and do not constitute or substitute for medical or healthcare advice or diagnosis, and may not and should not be used for such purposes. Individuals should always consult with a qualified healthcare provider about their specific circumstances, including before starting or stopping any treatment, medical or otherwise. DNA@ObG content via this web site is provided with the understanding that The ObG Project is not engaged in rendering medical, counseling, legal, or other professional services or advice.
Safety and Efficacy Data of BNT162b2 COVID-19 Vaccine
BACKGROUND AND PURPOSE:
BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein
The messenger RNA (mRNA) used in this vaccine includes the code used by SARS-CoV-2 to produce spike protein that helps the virus enter and infect cells
Following vaccination, the mRNA enters the vaccine recipient’s normal cells that will use the mRNA code to produce spike proteins that will generate an immune reaction
In the future, if the vaccine recipient is exposed to the SARS-CoV-2 virus, the antibodies generated by this immune system reaction will recognize and neutralize the invading virus
Polack et al. (NEJM, 2020) report on the safety and efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine in preventing COVID-19
Efficacy of the vaccine against laboratory-confirmed COVID-19
42,448 participants were randomized and received injections
BNT162b2: 21,720 participants
Placebo: 21,728 participants
BNT162b2 was 95% effective in preventing COVID-19
Placebo: 162 cases
BNT12b2: 8 cases (onset at least 7 days after the second dose)
(95% CI, 90.3 to 97.6)
Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by
Age | Sex | Race | BMI | Coexisting conditions
There were 10 cases of severe COVID-19 with onset after the first dose
Placebo: 9 cases
BNT162b2: 1 case
Mild-to-moderate pain at the injection site
Fever (≥38°C): After second dose: 16% of younger vaccine recipients (16 to 55 years) | 11% of older recipients (>55 years)
Fever ≥38.9 to 40°C
After first dose: 0.2% of vaccine recipients | 0.1% of placebo
After second dose: 0.8% of vaccine recipients | 0.1% placebo
2 participants each in the vaccine and placebo groups
Incidence of serious adverse events was low and similar for the vaccine and placebo groups
Two doses of BNT162b2 spaced 21 days apart conferred 95% protection against COVID-19 in people aged 16 and over with a safety profile similar to other vaccines
This study does not address the following populations
Adolescents | Children | Pregnant women
Vaccine requires very cold temperatures for shipping and long-term storage
Standard refrigerators can be used for up to 5 days when ready for use
The authors state
The data presented in this report have significance beyond the performance of this vaccine candidate
The results demonstrate that Covid-19 can be prevented by immunization, provide proof of concept that RNA-based vaccines are a promising new approach for protecting humans against infectious diseases, and demonstrate the speed with which an RNA-based vaccine can be developed with a sufficient investment of resources
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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