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TWN
Info Service on Health Issues (Feb24/04) New Delhi/Geneva, 12 February (K M Gopakumar and Nithin Ramakrishnan) – Text has been proposed by the Bureau of the Working Group on Amendments to the International Health Regulations 2005 (WGIHR) that seeks to make WHO prequalified vaccines as a compulsory requirement for the issuance of vaccine or prophylaxis certificates, raising concerns of vaccine supply concentration. This took place at the recent 7th meeting of the WGIHR held from 5 to 9 February 2024. Vaccine certificates are used as evidence of vaccination to facilitate international travel. Article 36 of the IHR states that travellers in possession of a vaccine certificate should not be denied entry unless the competent authority has verifiable indications and/or evidence that the vaccination or other prophylaxis was not effective. However, Article 36 obligates State Parties to issue vaccine certificates as per the conditions mentioned in Annex 6 and Annex 7. Annex 6 sets out the general conditions and model certificates for vaccination/prophylaxis certificates. Annex 7 sets out the conditions and model certificates for vaccination/prophylaxis certificates for specific disease. Currently Annex 7 lists only yellow fever vaccines. The contentious proposal is to amend Paragraphs 1 and 3 of Annex 6. These paragraphs currently states that only those vaccines or prophylaxis designated or approved by WHO should be used. Paragraph 1 states: “Vaccines or other prophylaxis specified in Annex 7 or recommended under these regulations shall be of suitable quality; those vaccines and prophylaxis designated by WHO shall be subject to its approval. Upon request, the State Party shall provide to WHO appropriate evidence of the suitability of vaccines and prophylaxis administered within its territory under these Regulations.” Paragraph 3 states: “Certificates under this Annex are valid only if the vaccine or prophylaxis used has been approved by WHO.” The amendment proposals are replacing the word approval with WHO prequalification. The Bureau’s proposal on Paragraph 1 states: “Vaccines
or other prophylaxis specified in Annex 7 or recommended under these
Regulations shall be of suitable quality; those vaccines and prophylaxis
designated by WHO shall be prequalified or listed for emergency
use by WHO The proposal on Paragraph 3 states: “Certificates
under this Annex are valid only if the vaccine or prophylaxis used
has been prequalified or listed for emergency use [The words in bold indicate the proposed text addition, and those in strikethrough are proposed for deletion]. The proposal to introduce these phrases came from the United States during the December 2023 meeting who is not an original proponent of the amendments to Annex 6. The Bureau co-chair who was keen to avoid the proposals relating to equity coming from non-original proponents showed no hesitance in adopting this proposal from the U.S. Countries like Malaysia, Mexico, Brazil, Indonesia and Colombia indicated that “approval of WHO” under Annex 6 should not be modified to make it too prescriptive about the scheme of approval. According to them, the language in Annex 6 should be generic in nature to include any modified or new processes that may be developed in the future. Brazil has suggested to incorporate “safety and efficacy” along with “suitable quality” in paragraph 1 as compromise language for retaining the original language relating to WHO’s approval. However, the Co-chairs reserved against Brazil’s proposal on the ground that it is a new proposal and did not allow further discussion on it. It is learnt that the WHO Secretariat itself offered to come out with an explanation or definition of the phrase “subject to its approval” in Annex 6 and discussions were accordingly suspended. It is important to note that the existing condition mentioned in Annex 6 i.e. the vaccine is subject to WHO approval does not necessarily mean that it is a WHO prequalified product. WHO prequalification is a specific product marketing approval that involves a process of evaluation of data and inspection of the manufacturing facility concerned by WHO. In contrast, WHO-approved vaccine means a vaccine which complies with the WHO specified safety and efficacy specifications. The rationale provided by the Bureau is as follows: “WHO prequalification and emergency use listing procedures for vaccines and medicines are intended to ensure that a common set of requirements regarding quality, safety and efficacy are met. The Bureau maintains that it is desirable to preserve the integrity of these mechanisms as those underpinning the use of vaccines and medicines in international travelers. Therefore, the Bureau proposes not to retain the proposed reference to the competent national / regional regulatory authority of the State Party in which territory the vaccine was administered”. However, the above rationale totally undermines the need for diversified production and adequate availability. Further, this amendment, if adopted, will make it compulsory to use only vaccines or prophylaxis that are WHO prequalified or listed for emergency use by WHO to issue vaccine/prophylaxis-related certificates. In current practice, only WHO prequalified vaccines or prophylaxis can be used to issue vaccine certificate for yellow fever and any other public health emergency of international concern (PHEIC) requiring issuance of certificates under IHR such as COVID-19. The insistence of prequalified or listed for emergency use vaccines or prophylaxis effectively institutionalises monopoly because only a few producers can usually obtain the prequalification or be listed for emergency use. For instance, according to the WHO pre-qualification vaccines list only four yellow fever vaccines from two manufactures are prequalified to date. Institut Pasteur de Dakar has three prequalified products and Sanofi Pasteur has one. Similarly, out of fifteen Covid-19 Emergency Use Listed vaccines from 12 manufactures, only 5 are from developing countries. These 5 manufacturers are Beijing Institute of Biological Products Co., Ltd. and Sinovac Life Sciences Co., Ltd from China, and Bharat Biotech International Ltd, Serum Institute of India Pvt. Ltd and Biological E. Limited form India. However, the supply from Bharat Biotech International Ltd is listed as suspended. It is pertinent to note that the Secretariat did not respond to the question on how many developing countries have Stringent Regulatory Authorities or WHO Listed Authorities which play a significant role in this process. The prequalification process is expensive. A recent report of the US International Trade Commission (ITC) observes that prequalification is expensive and delays access. It states: “These procurement agencies, however, rely on WHO prequalification (or emergency use listing) and guidance issuance for all tests and treatments, which were reported to have caused delays. In the case of some therapeutics, such as remdesivir, WHO recommendation and prequalification came a full two years after U.S. authorization and the first VLs (voluntary licences) were signed. This means that although treatments were available, many countries were not immediately able to access them. WHO prequalification, which is also required for certain MPP (Medicines Patent Pool) sublicensing agreements, requires significant effort by manufacturers in order to complete the application requirements and address data standards, which may be challenging for some manufacturers. It can also be costly. As noted in chapter 2, a one-time application fee of $25,000 is required in addition to a $20,000 annual fee for a full product assessment. Industry representatives have noted that these fees may be too expensive for smaller manufacturers in many LMICs”. When asked about the application cost and annual fee, the WHO Secretariat, which had made an expert presentation did not provide a direct answer. “They were very reluctant to spell the application fee and annual fee”, a delegate told TWN. Instead, the audience was told that 60% of the cost for evaluation work by WHO is to be borne by the manufacturers and the remaining through the contributions from Bill Gates Foundation, GAVI, and UNITAID. The ITC report also notes that the standard timeline for the prequalification in 270 days excluding the time for manufacturers to respond to evaluators’ questions. The Report also states: “In the case of diagnostics, WHO Emergency Use Listing Procedure (EUL) and official guidance delays were a significant factor for access to rapid antigen tests. The WHO issued its first two EULs for rapid antigen tests in September and November 2020, but the initial guidance did not recommend their use. The guidance in late December 2020 only recommended the use of rapid antigen tests in limited circumstances where molecular testing was unavailable. … The delays in EULs and guidance from the WHO likely reduced demand for rapid antigen tests in LMIC markets, despite the ample supply”. The delay in the prequalification process is also cited as a reason for the underperformance of efforts to facilitate COVID-19 diagnostics through the Access to COVID-19 Tools Accelerator (ACT-A), a multi stakeholder plat form set up under the aegis of WHO. The Strategic Review of ACT-A states: “Although progress has been made in lowering the price of tests, internal stakeholders expressed dismay that the price had not yet fallen further, citing below one dollar to be the critical threshold for expanding access and uptake. Currently, despite over 1,000 COVID-19 tests being commercially available, only four rapid tests have the necessary Emergency Use Listing (EUL) for WHO procurement (two of which are variations from the same manufacturer)”. The External Evaluation of ACT-A observes: “Access to certain diagnostic types was delayed due to late WHO clearance (especially for self-tests). Diagnostics are usually less complex to develop than drugs and vaccines. They are very important throughout the pandemic, especially at the beginning of pandemics when other MCMs (medical counter measures) are not available”. Similarly, there is a difference between the time line required for prequalification of a product approved by a stringent regulatory authority (SRA) and a product approved by a regulatory authority of a developing country. According to current practices “WHO’s work is essentially an abridged procedure to verify that the product submitted to WHO [prequalification] is indeed the one approved by the SRA”. Thus, the insistence of WHO prequalification essentially facilitates products approved by a limited number of SRA, bearing the danger of concentration of supply and undermining the efforts to diversify manufacturing.
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