FDA FINDS MODERNA’S COVID-19 VACCINE TO HAVE NO SPECIFIC SAFETY CONCERNS

The US Food and Drug Administration (FDA) has stated in its briefing document that Moderna’s experimental Covid-19 vaccine, mRNA-1273, is 94.1% effective in preventing symptomatic Covid-19.

This development comes ahead of a meeting by FDA advisers who will vote whether to recommend the grant of emergency approval for the vaccine in the US before a final FDA decision, Bloomberg reported.

The Moderna vaccine is based on SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles.

The proposed use of vaccine under an EUA is for active immunisation for Covid-19 prevention in adults.

Under the planned dosing regimen, two 100μg doses of the vaccine are to be given one month apart.

A safety data from an 11 November interim analysis of around 30,350 adults, who were randomly given the vaccine or placebo with a median of seven weeks of follow-up on receiving the second dose, showed a favourable safety profile.

Earlier this month, Moderna announced that the primary efficacy analysis data from the Phase III COVE study of mRNA-1273 indicated 100% vaccine efficacy against severe Covid-19.

SINGAPORE APPROVES PFIZER AND BIONTECH’S COVID-19 VACCINE

Singapore has approved the Covid-19 vaccine by Pfizer and its German partner BioNTech, and expects delivery of the first shots by December-end.

Singapore is the first Asian country to approve the vaccine, Reuters reported. The free vaccines will initially be administered to healthcare workers and the elderly.

The news agency quoted Singapore Prime Minister Lee Hsien Loong as saying in a national broadcast: “My colleagues and I, including the older ones, will be getting ourselves vaccinated early.

“This is to show you, especially seniors like me, that we believe the vaccines are safe.”

Pfizer and BioNTech have also announced additional data from the Phase I/II trial of its BNT162b2 Covid-19 vaccine conducted in Germany.

Data showed that the vaccine elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity.

BNT162b2 is authorised for emergency use in people aged 16 years or above.

ARCUS BIOSCIENCES AND WUXI BIOLOGICS EXPAND DEAL FOR ANTIBODIES DEVELOPMENT

Biopharmaceutical company Arcus Biosciences has expanded its existing strategic relationship with Chinese company WuXi Biologics to discover anti-CD39 antibodies using the latter’s proprietary technology.

It is the fourth antibody development programme for which the two firms have collaborated.

According to the agreement, Arcus will gain exclusive worldwide rights to anti-CD39 antibodies discovered under the partnership and handle all their further development and commercialisation activities.

Preclinical experiments showed that the combination of CD39 inhibition with either CD73 or adenosine receptor inhibition gives a strong inhibition of ATP-adenosine axis and improved anti-tumour immunity, Arcus noted.

Arcus Biosciences research head and president Juan Jaen said: “Our relationship with WuXi Biologics started in 2017 with a clinic-ready anti-PD1 antibody, zimberelimab, which possesses molecular properties similar to those of marketed anti-PD1 therapies and has shown impressive clinical anti-tumour activity.

“Furthermore, WuXi Biologics has been an excellent manufacturing partner for our anti-TIGIT antibodies, domvanalimab (AB154) and AB308.”

UK BECOMES FIRST COUNTRY TO INITIATE COVID-19 VACCINATION

The UK has started administering the Covid-19 vaccine, developed by Pfizer and its German partner BioNTech, outside a clinical trial, becoming the first country in the world to administer the new vaccine.

As part of the mass vaccination programme, a 90-year-old woman became the first person to receive the vaccine jab at University Hospital, Coventry. She will also receive a booster dose in 21 days.

In the phased programme, the vaccination will be initially given to patients aged 80 years or above in the outpatient setting, as well as those discharged after a hospital stay.

The Department of Health and Social Care in the UK asked the care home providers to initiate booking staff into vaccination clinics.

Delivered by a simple injection in the shoulder, the vaccine must be stored at -70C before being thawed out. Moreover, it can only be moved four times within that cold chain ahead of use.

The UK plans to administer 800,000 doses in the coming weeks and up to four million more jabs are expected by the month-end.

UK BIOBANK UNVEILS STUDIES TO MEASURE CIRCULATING PROTEIN CONCENTRATIONS

UK Biobank has announced that a consortium of ten biopharma companies will conduct a study to analyse circulating concentrations of almost 1,500 plasma proteins in around 53,000 of its participants.

Companies including Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Genentech, GlaxoSmithKline (GSK), The Janssen Pharmaceutical Companies of Johnson & Johnson, Pfizer, Regeneron and Takeda Pharmaceutical commissioned and funded the Pharma Proteomics Project.

Reported to be one of the largest studies of blood protein concentrations, the project will aim to enhance the field of proteomics, aiding in better understanding of disease processes and supporting the development of innovative drugs.

UK Biobank made available de-identified genetic data on its 500,000 participants to scientists to find potential DNA hotspots associated with human diseases.

These genetic variants can act as signposts for scientists in discovering and developing drugs.

Measuring various circulating proteins will aid in studying the link between genetic variation and circulating protein levels to understand the connection between genetics and human disease.

PFIZER SEEKS EUA FOR COVID-19 VACCINE FROM DCGI IN INDIA

Pfizer has reportedly submitted an application to the Drugs Controller General of India (DCGI) for an emergency use authorisation (EUA) for its Covid-19 vaccine in India.

Pfizer is the first company to seek approval from India’s drug regulator, CNN-News18 reported.

NDTV quoted VK Paul, who is advising the Indian government on Covid-19 matters, as saying: “We welcome interest from Pfizer to seek emergency licensure in our country.”

Paul added that typically DCGI may take up to 90 days to decide on such applications and give approval. However, a decision on Pfizer’s vaccine could be made much faster.