COVID-19 vaccine: Pfizer withdraws Emergency Use Authorisation application in India
New Delhi: Pharma major Pfizer on Friday said it has decided to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India.
Pfizer was the first pharmaceutical firm to seek an emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country, after it secured such clearance in the UK and Bahrain.
"In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. 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," a company spokesperson said in a statement.
Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement said.
"Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," the spokesperson said.
Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources had said.
Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.
Maharashtra sets up state vaccination task force to strengthen immunisation programme
Mumbai (PTI): The Maharashtra government has set up a State Vaccination Task Force to strengthen the regular immunisation programme and review the progress of related campaigns, a health department official said on Monday.
The State Vaccination Task Force will comprise at least 29 members and will be headed by the administrative head of the health department, he informed.
The government has also constituted separate district-level and municipal vaccination task forces to improve implementation and address challenges at the grassroots level, he said.
Municipal task forces, chaired by respective civic commissioners, have been constituted in view of the vast urban population in Maharashtra and the role of civic bodies in implementing different health programmes.
The district-level task forces will function under the chairmanship of collectors.
"Complete immunisation of children at the appropriate age is an extremely simple, cost-effective and highly effective measure to reduce child mortality and the prevalence of diseases among kids. Immunisation is a powerful tool for reducing illness in children," maintained the official.
To ensure full vaccination of all children, the state government implements various campaigns from time to time as per the central government guidelines, he pointed out.
"Active participation and cooperation of other relevant government departments are essential (in making these campaigns successful)," according to the official.
The state-level body will review the regular immunisation programme, associated campaigns and vaccine-preventable diseases in detail. It will also conduct focused assessments of high-risk districts and municipal corporations, including vacancies at district, municipal and sub-district levels, availability of cold chain equipment, resource gaps and training requirements, he noted.
The state task force will review allocation and utilisation of funds for immunisation and ensure timely action by officers concerned based on reports from district and municipal task forces and state-level monitoring mechanisms, the official said.
It will also ensure active coordination and participation of other government departments in immunisation drives, while district and municipal task forces will carry out similar functions at their respective levels, the official added.
