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peter doshi :: Article Creator New Research Reports On Financial Entanglements Between FDA Chiefs And The Drug Industry An investigation published by The BMJ today raises concerns about financial entanglements between US Food and Drug Administration (FDA) chiefs and the drug and medical device companies they are responsible for regulating. Regulations prohibit FDA employees from holding financial interests in any FDA "significantly regulated organization" and the FDA says it takes conflicts of interest seriously, but Peter Doshi, senior editor at The BMJ, finds that financial interests with the drug industry are common among its leaders. Doshi reports that nine of the FDA's past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company. That includes Margaret Hamburg, who led FDA between 2009 and 2015, but whose story is less well known. Like her colleagues, Margaret Hamburg h

Updates to the 2021 Adult Immunization Schedule - Monthly Prescribing Reference

The Advisory Committee on Immunization Practices (ACIP) approved the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States 2021 in October 2020. The 2021 schedule was approved by the Centers for Disease Control and Prevention (CDC), American College of Physicians, American Academy of Family Medicine, American College of Obstetricians and Gynecologists, American College of Nurse-Midwives, and the American Academy of Physician Assistants. This article consolidates and summarizes all of the updates to the 2020-2021 ACIP recommendations in regards to the use of each vaccine in adults, interim recommendations for the coronavirus disease 2019 (COVID-19) vaccinations, and guidance for the safe delivery of vaccines during the COVID-19 pandemic.1 The full ACIP recommendation for the Adult Immunization Schedule by Vaccine and Age Group is available on the CDC website.

Updates to the Interim Recommendations for COVID-19 Vaccines

ACIP recommends use of COVID-19 vaccines within the scope of the Emergency Use Authorization (EUA) or Biologics License Application for the particular vaccine. After conducting an evidence-based review of all data available at the time, the ACIP issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19 on December 12, 2020.2 On December 19, 2020, ACIP issued an interim recommendation for the use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19 following an EUA issued by the US Food and Drug Administration.3

Influenza Vaccination Updates1

Routine annual influenza vaccination is recommended for all persons aged 6 months and older without contraindications for the 2020-2021 flu season. The ACIP does not prefer one vaccine over another for persons in which more than one influenza vaccine product is applicable based on age and health status.

The live attenuated influenza vaccine (LAIV4) is an option for adults through age 49 years, except with immunocompromising conditions. According to the LAIV4 package insert, antiviral agents may reduce the effectiveness of LAIV4 if it is given within the interval from 48 hours before to 14 days after vaccination. Considering the longer half-lives of newer antiviral agents, the ACIP recommends that LAIV4 should not be used if a person received either oseltamivir or zanamivir within the previous 48 hours, peramivir within the previous 5 days, or baloxavir within the previous 17 days.


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Regarding persons with egg allergy with symptoms other than hives, if an influenza vaccine other than Flublok or Flucelvax is used, the vaccine should be administered in a medical setting under supervision of a health care provider who can recognize and manage severe allergic reactions.

The influenza vaccine is contraindicated in persons with a previous severe allergic reaction to the vaccine. Adults who have received a previous influenza dose and developed Guillain-Barre syndrome within 6 weeks of vaccination should not be vaccinated again unless benefits outweigh the risks.

Tetanus Toxoid, Diphtheria Toxoid, and Acellular Pertussis Vaccination Updates1

Language for wound management in the notes regarding the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) was updated. Specifically, for individuals who have received 3 or more doses of tetanus toxoid-containing vaccine, for clean and minor wounds, Tdap or Td should be administered if more than 10 years have passed since the last dose. For all other wounds, Tdap or Td should be administered if more than 5 years have passed since the last dose of tetanus toxoid-containing vaccine.

For those who have not previously received Tdap or whose Tdap history is unknown, Tdap is the preferred vaccine. Additionally, Tdap should be used to vaccinate pregnant women if a tetanus toxoid-containing vaccine is indicated.

Hepatitis A (HepA) Vaccination Updates1

ACIP recommends HepA vaccination in adults who are at risk for hepatitis A virus (HAV) infection or severe disease resulting from HAV infection or for adults requesting protection against HAV without risk factors. Under notes in travel in countries with high or intermediate endemic hepatitis A, language was added to include the accelerated schedule for Twinrix (HepA-HepB combination vaccine). The alternate 4-dose schedule includes doses at 0, 7, and 21-30 days, followed by a booster dose at 12 months.

Hepatitis B (HepB) Vaccination Updates1

ACIP recommends vaccination for hepatitis B virus (HBV) infection in the setting of adults who have high risk factors for HBV or adults requesting protection against HBV without risk factors. Under Special Situations, language was added in the notes to state that HepB vaccination is recommended by shared clinical decision-making for persons with diabetes aged 60 years or older.

Human Papillomavirus (HPV) Vaccination Updates1

Vaccination for HPV is recommended at 11 to 12 years, but can also be started at age 9 years. Catch-up is recommended through age 26 years.  Although public health benefit is generally minimal for adults aged 27 through 45 years, shared clinical decision-making is recommended because some may benefit from the HPV vaccine. Language under routine vaccination was changed to match the language in the child and adolescents dosing schedule. A bullet was added to state that additional doses of HPV are not recommended after completing a series at the recommended dosing intervals using any HPV vaccine. Bullet points were added to Special Situations: age ranges for routine and catch-up schedules also apply in these patients and the 3-dose series is recommended regardless of age of initial vaccination in immunocompromising conditions.

Meningococcal A, C, W, Y Vaccination Updates1

ACIP recommends routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for persons at risk for meningococcal disease caused by serogroups A, C, W, or Y and booster doses for those who were previously vaccinated who become or remain at risk. MenACWY-TT (MenQuadfi) was added to the schedule cover page to the list of approved MenACWY vaccines. MenACWY-TT was first licensed in 2020 for the prevention of meningococcal disease caused by serogroups A, C, W, Y in persons aged 2 years or older. A bullet regarding more information on booster doses was added in the notes.

Meningococcal B Vaccination Updates1

ACIP recommends routine vaccination with serogroup B meningococcal (MenB) vaccine in persons aged 10 or older who are at risk for serogroup meningococcal disease and MenB boosters are recommended for those who were previously vaccinated who become or remain at risk. ACIP recommends a MenB series for adolescents and young adults aged 16 to 23 years by shared clinical decision-making to provide short term protection against most strains of the serogroup B meningococcal disease. A bullet was added in the notes under Special Situations regarding more information on booster doses.

Pneumococcal Vaccination Updates1

ACIP recommends a routine single dose of PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in adults aged 65 or older. If not previously administered PCV13, PCV13 is recommended by shared clinical decision-making in persons aged 65 or older who do not have an immunocompromising condition, cerebrospinal fluid leak, or cochlear implant. If PCV13 is to be administered, it should be administered first, followed by PPSV23 at least 1 year later. A link for routine vaccination recommendations in persons aged 65 years or older was added to the notes for PCV13. Bullets were reordered under Shared Clinical Decision-Making.

Routine recommendations for the measles, mumps, and rubella (MMR), varicella, and zoster vaccinations have not changed for the 2020-2021 adult immunization schedule. Zoster vaccine live (ZVL, Zostavax) is no longer being sold in the United States, therefore, reference to Zostavax has been removed from the 2021 adult immunization schedule and the reference to recombinant zoster vaccine (RZV, Shingrix) being preferred was also removed.1 

For more on the complete ACIP recommended adult immunization schedule, including contraindications and additional guidance, please visit the CDC website.    

Vaccinations during the COVID-19 Pandemic

ACIP also emphasized the importance of routine vaccinations during the pandemic to prevent diseases. ACIP advised all providers to administer all due or overdue vaccines. Newborns, infants, and children up to age 24 months should be prioritized first, then young children and adolescents, and lastly adults. CDC recommends personal protective equipment and physical distancing for the safe delivery of vaccines during the COVID-19 pandemic. For more resources and checklists of best practices for vaccinations during the pandemic, please visit the CDC's Interim Guidance for Routine and Influenza Immunization Services During the COVID-19 Pandemic.

References

  1. Freedman MS, Bernstein H, Ault KA. Recommended Adult Immunization Schedule, United States, 2021. [published online February 11, 2021] Ann Intern Med. 2021 Feb 11. doi: 10.7326/M20-8080.
  2. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine – United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1922-1924. doi: 10.15585/mmwr.mm6950e2.
  3. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Moderna COVID-19 vaccine – United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1653-1656. doi: 10.15585/mmwr.mm695152e1.

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