Interessant: Pfizer hat bereits Anfang Februar 2021 seinen Antrag auf Notfallzulassung von Comirnaty zurückgenommen, nachdem der Prüfer die Durchführung einer Studie in Indien verlangt hat.
Indien verlangt grundsätzlich eine zusätzliche Studie, eine sog. “Brückenstudie”, in der die Sicherheit und Immunantwort in Indien geprüft wird. Die in Deutschland und den USA durchgeführte Immunogenitätsstudie sowie die in Deutschland, USA, Argentinien, Brasilien, Südafrika und der Türkei durchgeführte Sicherheitsstudie reichten der zuständigen Behörde nicht aus.
Die Europäische Arzneimittelagentur EMA hat u.a. diese Studien ihrer Entscheidung zur Erteilung der bedingten Zulassung zugrunde gelegt.
Pfizer hatte einen Ausnahmeantrag gestellt, um keine lokale Studie durchführen zu müssen. Dieser Antrag wurde abgelehnt mit der Begründung, dass im Ausland gemeldete Nebenwirkungen immer noch (Februar 2021) untersucht würden. Pfizer habe keinen Plan zur Erlangung von Sicherheits- und Immunogenitätsdaten in Indien vorgelegt.
Pfizer drops India vaccine application after regulator seeks local trial
NEW DELHI, Feb 5 (Reuters) – Pfizer Inc (PFE.N) said on Friday it had withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.
The decision means the vaccine will not be available for sale in the world’s two most populous countries, India and China, in the near future. Both countries are running their immunisation campaigns using other products.
Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany. read more
Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens. There are, however, provisions under India’s rules to waive such trials in certain conditions.
The U.S. company, which was the first drugmaker to seek emergency approval in India for its vaccine developed with Germany’s BioNTech (22UAy.DE), made the withdrawal decision after a meeting with India’s Central Drugs Standard Control Organisation (CDSCO) on Wednesday.
The drug regulator said on its website its experts did not recommend the vaccine because of side effects reported abroad were still being investigated. It also said Pfizer had not proposed any plan to generate safety and immunogenicity data in India.
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” Pfizer said in a statement.
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”
Reuters was the first to break the news. read more
Pfizer had sought authorisation for its vaccine in India late last year, but the government in January approved two much cheaper shots – one from Oxford University/AstraZeneca (AZN.L) and another developed in India by Bharat Biotech with the Indian Council of Medical Research.
Both companies had applied for approval of their vaccines after Pfizer, and their trials are ongoing in India. Local company Dr. Reddy’s Laboratories Ltd (REDY.NS) is running trials for Russia’s Sputnik V vaccine, which is expected to be approved this month or next. read more