Pharmaceutical giants Sanofi and Glaxo Smith Kline (GSK) on Thursday started a clinical trial for their jointly developed Covid-19 vaccine candidate.
A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US, the two drugmakers said.
The vaccine candidate uses the same recombinant protein-based technology as one of Sanofi's seasonal influenza vaccines with GSK's pandemic adjuvant technology.
The Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and immune response of the Covid-19 vaccine candidate.
The companies anticipate first results early December which will support the initiation of a Phase 3 trial in the same month.
If data are sufficient for licensure application, the plan is to request regulatory approval in the first half of 2021, French pharma company Sanofi and its British peer GSK said, adding that the two companies are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.
"Sanofi and GSK bring proven science and technology to the fight against the global Covid-19 pandemic, with the shared objective of delivering a safe and effective vaccine," Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said in a statement.
"The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat Cocid-19."
Preclinical data showed an acceptable tolerability profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralising antibodies that are comparable to levels in humans who recovered from the Covid-19 infection, the drugmakers said, adding that pre-clinical results will be published later this year.
"Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing," said Roger Connor, President of GSK Vaccines.
Sanofi and GSK said they are committed to making the vaccine available globally.
Locals’ stage road blockades remanding power restoration, lift stir after assurance
Residents of Kulubari under Sonamura Sub-divison frustrated by the prolonged lack of electricity, staged a blockade on the Sonamura Boxanagar road demanding immediate action.
20 Company jawans of TSR to go Himachal Pradesh and Odisha for poll duty
The Tripura State Rifles (TSR), renowned as an elite counter-insurgency force, is currently gearing up for election duty in various regions across India. Recent reports indicate that 20 companies, totaling 1,600 personnel,
Club Secretary murder row: Court sends two to four days Police Remand
The Chief Judicial Magistrate Court of West District has remanded two individuals, including a woman, to police custody until May 7 in connection with the murder of Durga Prasanna Deb, also known as Viki, who served as the secretary of the Bharat Ratna Sangha club in Agartala which is the largest social club of Tripura.
Two held for involving in human trafficking case in Tripura
Speaking with reporters on Saturday, Officer-In-Charge of Government Railway Police Station, Tapas Das, stated that the arrests were made based on the interrogation of six Bangladeshi nationals who were detained on April 30 at Agartala Railway Station after illegally crossing the international border.
Mini School Bus mishap leaves driver critically injured, children slightly hurt
In a harrowing incident today, a mini school bus belonging to a private school met with a grave accident in the vicinity of Paschim Dewan Pasha Gram Panchayat.
Rs 1.22 crore power infrastructure destroyed in thunderstorm struck Tripura
A thunderstorm that struck Tripura on Thursday has destroyed power infrastructure worth Rs 1.22 crores, including 166 km of crucial transmission lines, 235 electric poles, and 30 transformers suffering irreparable damage.
Mayor distributes water, fruits to common people
In a thoughtful gesture to combat the scorching summer heat, Ward No. 35 of Agartala Municipal Corporation extended a refreshing hand to the common people.
Youth Congress demands resignation of TSCB MD after fatal bus accident
The delegation representing Pradesh Youth Congress managed to enter the premises of the bank and held discussions with the acting Managing Director, in the absence of the MD.