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Safety in Lactation: Vaccines and antisera

21 September 2020Although vaccines and toxoids (diphtheria and tetanus) are considered to be compatible with breastfeeding, their use should be limited to those situations where there is…

Vaccination and antibiotic prescribing in patients with asplenia or splenic dysfunction in primary care

24 April 2019Following the death of a young asplenic patient in 2016 our project involves the identification and review of asplenic or hyposplenic patients in primary care,…
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Refrigerated Storage

Prevenar 13Pfizer limited

Pfizer limited
Prevenar 13
Suspension for injection

In the event of an inadvertent temperature excursion the following data may be used:

Prevenar 13 may be exposed to temporary elevated temperature excursions (such as a refrigerator malfunction) of up to 25°C for a cumulative period of up to 7 days.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

No
Yes
3 August 2020
London MI Service

Pneumococcal Polysaccharide VaccineMerck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Pneumococcal Polysaccharide Vaccine
Solution for injection in a vial

Contact MSD in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Do not freeze.

15 May 2020
London MI Service

Lactation Safety Information

Yes
Inactivated vaccines (containing components of between 13 and 23 types of pneumococcus)
11 September 2020

New Medicines

VaxneuvancePneumococcal infection - prevention in adults and elderly

Information

Vaxneuvance
New formulation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

None
Pre-registration (Filed)
Approved (Licensed)
Jul 21MSD announces FDA have approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older [11]
Jan 21US FDA accept Biologics License Application (BLA) for V114 for priority review. This is based on PII and PIII trials in adults inc. those >65 years. The BLA has a target action date of July 18, 2021. It is also being reviewed by the European Medicines Agency (EMA). [9]
Nov 20Merck has submitted applications to the U.S. FDA and EMA for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older [8].
Oct 20Company announce plans to apply to regulatory agencies before end of 2020, starting with the US FDA. [7]
Dec 19PIII (NCT03547167) trial is currently active, but not recruiting. Primary completion data is anticipated in Jan 20 [4]

Category

15-valent pneumococcal vaccine conjugate
Infection with Streptococcus pneumoniae (pneumococcus) is common and may produce a range of illnesses - some more serious than others - eg, otitis media, meningitis, septicaemia and pneumonia. Serious or life-threatening infection is seen more commonly in children, the elderly, patients who have had their spleen removed and in immunocompromised patients [1].
Pneumococcal infection - prevention in adults and elderly
Intramuscular

Trial or other data

Oct 20Data from PIII PNEU-PATH trial of V114 in healthy adults >50 years. At 30 days after vaccination with either V114 or PCV13 (PNEUMOVAX 23) immune responses were comparable between arms across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F. The PIII PNEU-DAY study of V114 vs. PNEUMOVAX 23 in adults aged 18-49 at risk of pneumococcal disease also showed that, after 6 months, V114 led to immune responses comparable to PCF13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days after vaccination.[7]
Oct 20Data from PIII PNEU-PATH trial of V114 in healthy adults >50 years. At 30 days after vaccination with either V114 or PCV13 (PNEUMOVAX 23) immune responses were comparable between arms across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F.[7]
Sep 20Merck announce PNEU-AGE study in healthy adults ≥50 years showed V114 was non-inferior to the 13-valent vaccine for the 13 serotypes targeted by both and superior for 22F and 33F (targeted only by V114). In PNEU-TRUE, equivalent immune response across all serotypes was seen for three different lots [6].
Jun 20Merck announce PNEU-WAY (V114-018) study in adults with HIV showed V114 elicited immune response to all 15 serotypes included in vaccine, including 22F and 33F. PNEU-FLU (V114-021) study in healthy adults age ≥50 years showed V114 can be given concomitantly with quadrivalent flu vaccine [5].
Jul 18PIII trial to evaluate safety, tolerability and immunogenicity of V 114 followed by administration of PNEUMOVAX 23 six month later in vaccine-naïve immunocompetent adults at increased risk of pneumococcal disease, compared with Prevnar 13 starts (PNEU-DAY; NCT03547167). The trial intends to enrol 1500 adults in the US [2].
Jul 18PIII trial to evaluate the safety, tolerability and immunogenicity of V 114 and Prevnar 13 in pneumococcal vaccine-naïve adults infected with HIV and the safety, tolerability, and immunogenicity of PNEUMOVAX 23 when administered eight weeks after receipt of either V 114 or Prevnar 13 starts (PNEU-WAY; NCT03480802). The trial is enrolling approximately 300 patients in the US [2].
Jun 18PIII trial to evaluate the safety, tolerability and immunogenicity of V 114 followed by administration of PNEUMOVAX-23 one year later in healthy adults 50 years of age or older starts (PNEU-PATH; NCT03480763). The trial is enrolling approximately 600 volunteers in the US [2].

Prevnar 20Pneumococcal infection - prevention (20-valent)

Information

Prevnar 20
New formulation
Pfizer
Pfizer

Development and Regulatory status

None
Pre-registration (Filed)
Approved (Licensed)
Jun 21Approved for use in adults in the US. Development for use in children is ongoing with application expected late 2022 [15]
Feb 21EMA has accepted for review the MAA for 20-valent pneumococcal conjugate vaccine for prevention of invasive disease and pneumonia caused by S. pneumoniae serotypes in adults [14].
Dec 20Granted priority review in US with target action date of June 2021 [11].
Oct 20 Pfizer announces intention to submit MAA to EMA for Pneumococcal infections (In adults, Prevention) in Q1 2021. [13]
Sep 20Granted a breakthrough therapy designation for the prevention of pneumococcal infections in infants, children, and adolescents. [12]
May 20PIII adult clinical trials (NCT03760146, NCT03828617, and NCT03835975) evaluating the vaccine for prevention of invasive disease and pneumococcal pneumonia now completed [10].
Sep 19Enrolment in PIII trials in adults now complete and Pfizer plans to file in the US for adults by the end of 2020 [8].
Sep 19PIII studies in children are planned following data from the 4th dose becoming available.[7]
Sep 18Granted breakthrough therapy designation in the US for adults [1]
Oct 17Granted fast track designation in the US for adults [1]
May 17Granted fast track designation in the US for paediatrics [1]

Category

A 20-valent pneumococcal conjugate vaccine being developed to potentially extend coverage to include additional serotypes prevalent in causing pneumococcal disease in children and adults [3]
Infection with Streptococcus pneumoniae (pneumococcus) is common and may produce a range of illnesses - some more serious than others - eg, otitis media, meningitis, septicaemia and pneumonia. Serious or life-threatening infection is seen more commonly in children, the elderly, patients who have had their spleen removed and in immunocompromised patients.
Pneumococcal infection - prevention (20-valent)
Intramuscular

Trial or other data

Jul 20Pfizer reported achievement of proof-of-concept for PF-06482077. Results from the PII trial demonstrated that the vaccine candidate was safe and well-tolerated and induced functional immune responses that could kill all twenty serotypes. Pfizer is currently planning PIII program [2]
Mar 20PIII study (NCT03760146) results, which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The primary immunogenicity objectives of non-inferiority was met for 19 of the the 20 serotypes in adults 60 years of age and older at one month after vaccination. The other serotype missed non-inferiority by a small margin. Data are expected to meet licensure criteria and license is expected late 2020 [9].
Sep 19Pfizer announce positive preliminary from PII B7471003 study (NCT03512288) to assess safety and immunogenicity of 20-valent pneumococcal conjugate vaccine (20vPnC) for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes in healthy infants. The initial three doses of 20vPnC were found to have an overall safety profile similar to Prevnar 13. These data will be published once safety and immunogenicity data have been analysed following the completion of the four-dose regimen.[7]
Apr 19Pfizer report robust immunogenic responses for all 20 vaccine serotypes in the 20vPnC group of PII study. Injection site reactions (redness, swelling or pain) and systemic event rates were similar after vaccination with 20vPnC or Prevnar 13 [6]
Feb 19Pfizer announces 20vPnC includes 13 serotypes contained in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) plus 7 additional serotypes (8, 10A, 11A, 12F, 15BC, 22F and 33F). The 7 new serotypes are global causes of invasive pneumococcal disease; 6 serotypes (8, 10A, 11A, 15BC, 22F and 33F) are associated with high case-fatality rates; 4 serotypes (11A, 15B/C, 22F and 33F) with antibiotic resistance, and/or meningitis (10A, 15B/C, 22F and 33F). Together, all 20 serotypes included are responsible for the majority of currently circulating pneumococcal disease in adults [5].
Feb 19Pfizer initiates PIII trials (NCT03828617, NCT03835975 and NCT03760146) evaluating 20vPnC in adults. Combined, these three trials will enroll more than 6,000 adult subjects, including populations of vaccine-naïve adults and adults with prior pneumococcal vaccination
Dec 18PIII trial announced |(NCT03760146) that will enroll around 3,880 adults ≥60 years old to compare immune responses after 20vPnC administration with 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccines [4].

VaxneuvancePneumococcal infection - prevention in children and adolescents

Information

Vaxneuvance
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

15-valent pneumococcal vaccine conjugate
Infection with Streptococcus pneumoniae (pneumococcus) is common and may produce a range of illnesses - some more serious than others - eg, otitis media, meningitis, septicaemia and pneumonia. Serious or life-threatening infection is seen more commonly in children, the elderly, patients who have had their spleen removed and in immunocompromised patients.
Pneumococcal infection - prevention in children and adolescents
Intramuscular