Pfizer Inc

Evaluated: medicine & vaccine pipelines for priority* bacteria & fungi

A.1 Investments in R&D 
Pfizer does not disclose publicly, or to the Benchmark, its R&D investments during 2019 and 2020 in antibacterial and antifungal medicines and/or vaccines for pathogens in scope. Pfizer has pledged USD 100 mn to the AMR Action Fund over the next ten years. 
 
A.2.1 Pfizer nearly doubles the size of its pipeline 
The company reports 13 projects targeting pathogens in scope: eight medicines and five vaccines. Twelve targeting bacterial pathogens and one targets fungal pathogens. Out of the 13 projects, five are in discovery/preclinical stage, six are in clinical development and two received marketing approval.

A.2.2 Both innovative and adaptive medicine clinical candidates
Pfizer’s clinical-stage medicine pipeline consists of both innovative and adaptive R&D projects. Pfizer is working on extending the indications of ceftazidime/avibactam (Avycaz®/Zavicefta®) and ceftaroline fosamil (Teflaro®/Zinforo®). It is developing the combination of aztreonam/avibactam (PF-06947387) against MDR gram-negative infections. In April 2021, Pfizer acquired Amplyx Pharmaceuticals Inc and is now taking over the clinical development of its novel antifungal, fosmanogepix.

A.2.3 Five vaccine candidates
Pfizer reports five vaccine projects in its pipeline. It includes three innovative and two adaptive projects. Pfizer’s vaccines in clinical stages of development include candidates targeting C. difficile, group B Streptococcus and S. pneumoniae. In June 2021 Prevnar20®, a 20-valent pneumococcal vaccine was approved by the FDA. Pfizer is conducting Phase III trials to extend the use of this newly approved vaccine to paediatric populations. 

A.2.4 Seven candidates targeting critical and/or urgent priorities
Pfizer has seven projects targeting pathogens defined as ‘critical’ by WHO’s list of priority pathogens and/or characterised as ‘urgent’ threats by the US Centers for Disease Control and Prevention (CDC). In clinical development, Pfizer has medicine candidates against Carbapenem-resistant/ESBL-producing E. coli and C. auris, and a vaccine candidate targeting C. difficile.

A.3 Comprehensive planning for access and stewardship
Pfizer has eight late-stage R&D projects targeting pathogens in scope, the highest number across all the R&D-based companies evaluated, four of them are vaccines. Three are in Phase II, three in Phase III and two have obtained marketing approval. 
For seven out of eight of its projects in late-stage development, Pfizer has ongoing clinical trials or aims to file the successful products in access countries§. The plans for this projects include a wide range of access components such as filing for registration in access countries§, equitable pricing and measures to strengthen supply. Furthermore, its late-stage R&D medicine projects are covered by portfolio-wide stewardship plans, including initiatives for surveillance (ATLAS) and research and education on AMR (via unrestricted grants). For its recently acquired Phase II antifungal, fosmanogepix, Pfizer plans to continue the Expanded Access Programme that Amplyx Pharmaceuticals Inc had in place.

Evaluated: antibacterials manufacturing (APIs and drug products)

B.1 Comprehensive environmental risk-management for own sites and suppliers; tracks compliance with limits at own sites
Pfizer reports a comprehensive strategy to minimise the environmental impact of wastewaters and solid waste from antibacterial manufacturing at its sites, including audits every three years. It reports setting discharge limits in the receiving environment for all antibacterials manufactured at its sites, based on PNECs to limit AMR, as recommended by the AMR Industry Alliance. Discharge levels are quantified at all sites using a mass balance approach, verified by chemical analysis if applicable. It reports that compliance of own sites with discharge limits is tracked.

Pfizer requires third-party suppliers of antibacterials to follow the same standards, including limits based on PNECs. It reports conducting on-site audits at least every five years. It requests and reviews the discharge levels of its suppliers. All supplier sites have quantified discharge levels. 

Pfizer expects external private waste-treatment plants to comply with its general environmental standards. It audits these plants every 3-6 years which includes the suitability of technologies used for processing waste and protocols for preventing contamination. It also employs conservative measures for effluents sent to external private and public wastewater treatment plants.

B.2 Publicly discloses some information on environmental risk management and commitment to set limits
Pfizer publishes some components of its environmental risk-management strategy. It is a member of the AMR Industry Alliance, which publishes a list of recommended antibacterial discharge targets. Pfizer publishes its commitment to setting these targets. It also publicly discloses that it is developing a, AMR Industry Alliance sponsored, consensus-based standard to demonstrate responsible manufacturing of antibiotics. Pfizer publicly discloses that >90% of own sites are compliant with the guidelines of the AMR Industry Alliance, and that >80% suppliers are assessed against these guidelines. It is unclear whether such compliance also includes compliance with discharge limits. Pfizer does not publish: (1) the results of environmental audits, conducted at its own sites, the sites of suppliers and/or external private and public waste-treatment plants; (2) a list of these suppliers and plants; or (3) the levels of antibacterial discharge from its own or suppliers’ sites.

B.3 System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective action 
Pfizer reports that its own sites and suppliers have a system to maintain high-quality antibacterial production consistent with international GMP standards. This includes periodic risk-based audits and tracking of corrective and preventive actions. Pfizer also requires its suppliers to audit their own suppliers. The Benchmark found no requests for official corrective action from the FDA or EMA related to non-conformities with cGMP at Pfizer’s own sites or any subsidiaries that manufacture antibacterials.

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries§

C.1.1 Filed to register on-patent medicines in 14 access countries on average
Pfizer performs above average, filing four of its five relevant on-patent medicines for registration in 14 access countries§ on average. Its most widely filed relevant product is the antifungal anidulafungin (Eraxis; Ecalta®) used to treat invasive candidiasis, filed in 22 access countries. Its reserve antibiotic, ceftazidime/avibactam (Zavicefta®), was filed for registration in 20 access countries, including three LICs. Its antifungal isavuconazole (Cresemba®) was filed for registration in nine access countries.

C.1.2 Filed to register off-patent/generic medicines in 17 access countries on average
Pfizer performs above average, filing eight of ten relevant off-patent/generic medicines for registration in 17 access countries on average. Its most widely filed relevant product is the antifungal fluconazole, filed in 52 access countries. Six of its sample products are filed in less than 10 access countries. Four of its sample products are filed for registration in at least one LIC.  

C.1.3 Filed to register on-patent vaccines in 24 access countries on average
Pfizer has an average performance, filing three of its four relevant on-patent vaccines for registration in access countries. Its most widely filed relevant vaccine is the Pneumococcal Conjugate Vaccine (13-valent) (Prevnar 13®) filed in 65 access countries. Prevnar 13® is followed by the meningococcal vaccine Nimenrix® , filed for registration in 23 access countries, including LICs. 

C.2.1 Several strategies to expand access to on-patent medicines 
Pfizer performs above average, with access strategies reported for three of five relevant on-patent medicines. It aims to expand access to its on-patent medicines in access countries through equitable pricing policies, one price per patient capitation model, and patient assistance programmes. To set the prices of ceftazidime/avibactam (Zavicefta™) and isavuconazole (Cresemba®), Pfizer takes into account local economic conditions, the average income, and GDP growth. It allows for net price flexibility for specific procurement requests. Pfizer provides evidence of patient reach and geographic reach for all its reported approaches. It estimates to have ensured access to ceftaroline (Zinforo®) ceftazidime/avibactam (Zavicefta™) and isavuconazole (Cresemba®) for 51,000 cumulative patients in low- and middle-income countries in 2020.

C.2.2 Several strategies to expand access to off-patent/generic medicines 
Pfizer performs above average, with access strategies reported for four of its ten relevant off-patent/generic medicines. It aims to expand access in low- and middle-income countries through donations and public/private partnerships. It provides evidence of patient and geographic reach for all its reported approaches. Pfizer takes part in the International Trachoma Initiative (ITI) and donated 31 mn azithromycin treatments to 12 countries in 2020. It extended its donation programme until 2025. Through its Diflucan® Partnership Program, Pfizer distributed 7mn doses of fluconazole to nine access countries through governments and NGOs in 2019 and 2020.

C.2.3 Several strategies to expand access to on-patent vaccines 
Pfizer performs above average, with access strategies reported for one of its four relevant on-patent vaccines. It aims to expand access in access countries through equitable tiered pricing, public/private partnerships, humanitarian emergency assistance settings and tenders. It has set a six-tiered pricing policy for Prevnar 13®. The tiers are defined by several criteria such as countries’ GNI per capita. Pfizer partners with Gavi to provide Pneumococcal Conjugate Vaccine (13-valent) (Prevnar 13®) to Gavi-eligible and Gavi-transitioned countries at a public price of USD 2.90 per dose until 2027. Pfizer provides evidence of patient reach and geographic reach for all its reported approaches. It commits to supply 930 mn doses of its Pneumococcal Conjugate Vaccine (13-valent) (Prevnar 13®) by 2027 through its partnership with Gavi.

C.3 Several strategies to ensure continuous supply 
Pfizer performs above average, with strategies reported in all four areas assessed. Pfizer ensures accurate demand planning and data analytics by forecasting on a monthly and 24-month rolling basis. Pfizer mitigates against shortage risks by keeping buffer stocks for its finished products at country-level, for APIs at a global-level, and manufactures some of its APIs in-house. Pfizer reports one technology transfer initiative. Since 2014, it has engaged in a public/private partnership in South Africa to enable a local partner to manufacture Pneumococcal Conjugate Vaccine (13-valent) (Prevnar 13®). To mitigate against substandard and falsified products, Pfizer maintains a Disruption Programme which identifies and disrupts online illicit sales. Pfizer uses serialisation with unique products identifiers and has a public counterfeit awareness page.

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally 

C.4 Comprehensive COI mitigation strategies in place for its educational programmes
Pfizer performs strongly in conflict of interest (COI) mitigation for the five AMR-related educational programmes for HCPs assessed by the Benchmark. To mitigate COI for all five programmes, it provides financial resources to independent third parties (BSAC, the University of Dundee, EBRD, ISID and Micron) to develop the programme.

C.5 Engages in sales and marketing practices to address appropriate use
Pfizer performs above average in sales practices. It reports that it partly decouples incentives for sales agents from sales volumes of its antibacterial and/or antifungal medicines. Its percentage of variable pay is capped at 30% and sales targets are set at the national level. Its incentives for sales agents in emerging markets in Asia are provided on the basis of confidentiality. However, Pfizer does not reward its sales agents based on antibacterial volumes sold in the UK.
Pfizer engages in marketing practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines consistent with the approved indication. Its marketing materials reflect emerging resistance trends and/or include treatment guidelines for healthcare professionals: for all antibacterial medicines and isavuconazole (Cresemba®), by using data from its ATLAS surveillance programme in the materials.

C.6 Makes three types of brochure and/or packaging adaptations to facilitate appropriate use by patients
Pfizer adapts packaging to facilitate the appropriate use of azithromycin (Zithromax®) by patients. Pfizer performs strongly in this measure, taking account of adherence to treatment, paediatric use and language. It adapts the packaging of azithromycin, named the Z-Pak, which facilitates patient adherence by organising the pill intake for each day, so that the patient knows exactly which pill(s) to take on which day until the Z-Pak is completed. Moreover, Pfizer includes a QR code on the packaging of azithromycin as an oral suspension that directs patients to a video explaining how to administer the oral suspension properly for adults and children. This is applied in Vietnam and the Philippines and the video will be played in the local language. Finally, Pfizer has translated instructions on the packaging to the local language in Japan.

C.7 Active in multiple AMR surveillance programmes; one openly shares raw data
Pfizer leads in this area. It is active in multiple AMR surveillance programmes. It runs the multinational ATLAS programme, which is focused on resistance against its antibacterial and antifungal medicines in 81 countries and has been running since 2004. Pfizer shares the raw data on the AMR Register, an open-access data platform, as well as the aggregated results on the ATLAS website and through peer-reviewed open-access journal articles. For the remaining programmes, only the aggregated results are shared through peer-reviewed open-access journal articles, as well as on open-access data platforms for the SENTRY programme (an antifungal resistance programme managed by JMI laboratories) and the CANWARD programme (a national programme managed by the Canadian Antimicrobial Resistance Alliance).