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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…
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Refrigerated Storage

Prevenar 13Pfizer

Pfizer
Prevenar 13
Suspension for injection

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

Prevenar 13 is licensed for storage at temperatures up to 25°C for four days. At the end of this period, any unused Prevenar 13 should be discarded.

In-house stability data shows 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.

Public Health England has guidance on responding to errors in vaccine storage, handling and administration.

25 February 2022
London MI Service

Pneumovax 23Merck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Pneumovax 23
Solution for injection in pre-filled syringe

Contact MSD in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

Public Health England has guidance on responding to errors in vaccine storage, handling and administration.

23 February 2022
London MI Service

ApexxnarPfizer

Pfizer
Apexxnar
Suspension for injection in pre-filled syringe

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

Apexxnar is stable for 96 hours when stored at temperatures from 8°C to 25°C. At the end of this period Apexxnar should be used or discarded.

The vaccine is also stable when exposed for a cumulative storage at 25 ºC ± 2 ºC for 9 days after which the vaccine was returned to licensed storage conditions through its remaining shelf life.

A single excursion of 40 ± 2ºC is allowed for up to 14 days. Once an exposure has occurred, there is no information regarding returning the vaccine to the fridge in this case.

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

UK Security Health Agency has guidance on responding to errors in vaccine storage, handling and administration.

See above
19 October 2022
London MI Service

VaxneuvanceMSD

MSD
Vaxneuvance
Suspension for injection in pre-filled syringe

In the event of an inadvertent temperature excursion the following data may be used:
Stability data indicate that Vaxneuvance is stable at temperatures up to 25°C for 48 hours.

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

7 October 2022
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 of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults

Information

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

Development and Regulatory status

Launched
Approved (Licensed)
Launched
July 22
Jul 22Vaxneuvance is available in the UK. Suspension for injection in a pre-filled syringe, 1=£50.30 [16]
Dec 21Approved in UK for same indication as EU [14].
Dec 21Approved in the EU for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older [13]
Oct 21Launched in US [15].
Oct 21Recommended for EU approval by CHMP “for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older”. Vaxneuvance will be available as suspension for injection [12].
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 of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults
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]
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].

Evidence based evaluations

Apexxnar (UK/EU), Prevnar 20 (US)Pneumococcal infection - prevention in adults (20-valent)

Information

Apexxnar (UK/EU), Prevnar 20 (US)
New formulation
Pfizer
Pfizer

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
June 2022
Sep 22NHS list price for Apexxnar vaccine 0.5ml pre-filled syringes is £56.50 [21].
Jun 22June 22: Available in UK. Full licence “Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older” [19,20].
Mar 22Apexxnar is approved by the MHRA for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older [18]
Feb 22Approved in the EU for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older [17].
Dec 21Committee for Medicinal Products for Human Use of EMA has issued a positive opinion to recommend the granting of a marketing authorization for Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older. Trade name in the EU to be: APEXXNAR [16]
Jun 21Prevnar 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis [16].
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 in adults (20-valent)
Intramuscular

Trial or other data

Oct 21Pfizer announce positive top-line results from PIII study (n= 1,796) exploring co-administration of Prevnar 20 with influenza vaccine in older adults. Responses elicited by PREVNAR 20 for all 20 serotypes and by seasonal influenza vaccine when given together were non-inferior to those elicited when the vaccines were administered one month apart in adults ≥65 years [16].
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].

Evidence based evaluations

Apexxnar (UK/EU), Prevnar 20 (US)Pneumococcal infection prevention in children (20-valent)

Information

Apexxnar (UK/EU), Prevnar 20 (US)
Licence extension / variation
Pfizer
Pfizer

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

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
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 (20-valent)
Intramuscular

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
Launched
Launched
Oct 22Licence change approved in EU [11].
Sep 22Recommended for EU approval by CHMP – the extension to the existing indication is “for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age” [10].
Jun 22FDA approves use of Vaxneuvance for children ages 6 weeks to 17 years. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to make its recommendations on the use of Vaxneuvance in the pediatric population. Children make up 80% of the pneumococcal vaccine market [9].
Apr 22FDA extends its deadline for a regulatory decision to July 1, requesting additional analyses of data [8].
Dec 21FDA has accepted, for Priority Review, a sBLA with a target action date of April 2022 [7]
May 21Merck plan to file a sBLA to FDA Q4 21 [5].
Feb 19Granted breakthrough therapy status in the US for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in paediatric patients 6 weeks to 18 years of age [1]

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

Trial or other data

Aug 21The PIII PNEU-PED-EU-1 trial (EudraCT2018-003787-31; NCT04031846) completed which evaluated the safety, tolerability, and immunogenicity of V114 in healthy infants. The randomised, double-blind trial was initiated in Sept 2019 and enrolled 1,188 European patients. The PIII PNEU-PED-EU-2 trial to evaluate the safety and tolerability of V114 (EudraCT2018-003788-70; V114-026; NCT04016714) is ongoing [6]
May 21Merck announce topline results from two PIII trials. The NEU-DIRECTION trial found immune responses in children treated with a 4-dose PCV13 series and in those treated with a mixed dose schedule of PCV13 followed by V114 were comparable. In the PNEU-PLAN trial, a catch-up regimen was considered comparable to PCV13 [5].
Jan 21PIII PNEU-ERA trial (NCT04193215) still recruiting now with an estimated primary completion date of June 2023.[4]
Dec 19MSD plans PIII (NCT04193215) PNEU-ERA trial for prevention of vaccine type acute otitis media in infants. The study is not yet recruiting but intends to recruit 4000 participants with an estimated primary completion date of June 22 [3].
Feb 19Breakthrough status in the US is based on results from immunogenicity data from two studies. Study 005 (NCT02531373) was a PI/II, multicentre, randomised, double-blind study to evaluate the safety, tolerability and immunogenicity profiles of 4 different lots of V114 in healthy adults and infants. Study 008 (NCT02987972) was a proof of concept, PII, paediatric trial to confirm the results from Study 005 in a larger population of infants. In both studies, V114 induced an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines [1].
Dec 18The double-blind, randomised PIII PNEU-LINK trial has commenced (n=2400 planned) in the US and Canada. The trial aims to evaluate the safety and tolerability of V114 and Prevnar 13 in healthy infants (NCT03692871; V114-031) [2].
Oct 18The double-blind, randomised PIII PNEU-DIRECTION trial has commenced enrollment (n=900 planned) in the US and Puerto Rico. The trial will evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13 in healthy infants switched from Prevnar 13 to V114 during the Pneumococcal Conjugate Vaccine (PCV) immunisation schedule (NCT03620162; V114-027) [2].