Gavi collaborates with Salesforce for Covid-19 vaccine distribution
16 december | Covid-19
Gavi, the Vaccine Alliance, has collaborated with cloud-based software company Salesforce to help the former in handling critical information to fairly distribute two billion Covid-19 vaccines to 190 countries by the end of next year.
Gavi is a public-private partnership aimed at providing vaccines to the poorest countries in the world.
In June, Gavi and other partners launched a global alliance called COVAX.
Its objective is to ensure that people obtain global access to Covid-19 vaccines, irrespective of their wealth.
Salesforce Work.com for Vaccines, Experience Cloud and Nonprofit Cloud will power the Gavi’s COVAX country engagement platform to handle critical data.
Under the COVAX, all participating countries can make use of Salesforce’s secure portal for communicating and sharing information such as vaccine requirements and access reports.
Lower-income countries eligible for support by COVAX can utilise the site to give information that will aid in the planning of vaccine doses to be rolled out.
For the higher-income, self-financing countries that are part of COVAX, the portal can be used to obtain updates on their financial position since it changes with time.
16 december | covid-19
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.
15 december | vaccines
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.
14 December | Covid-19
US FDA AUTHORISES PFIZER AND BIONTECH’S COVID-19 VACCINE
The US FDA has authorised the emergency use of Pfizer and BioNTech’s mRNA vaccine, BNT162b2, against Covid-19 in individuals aged 16 years and above in the country.
At present, the vaccine is authorised under an Emergency Use Authorisation (EUA).
Pfizer and BioNTech are also collecting additional data and gearing up to submit a planned Biologics License Application (BLA) to the FDA for a full regulatory approval next year.
Previously, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favour of EUA grant to Pfizer and BioNTech’s BNT162b2.
The Department of Defense (DoD), along with agencies within the Department of Health and Human Services (HHS), including the US Centers for Disease Control and Prevention (CDC), will handle the allocation and distribution of vaccine in the country under Operation Warp Speed programme.
The CDC Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of the vaccine in people aged 16 years and above under the EUA.
It directs the CDC on population type and situations for which vaccines should be used.
10 december | deals
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.”
08 december | vaccines
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.
AstraZeneca’s heart failure treatment Forxiga gets approval in Japan
The Japanese Ministry of Health, Labour and Welfare has approved AstraZeneca’s Forxiga (dapagliflozin) for treating patients with chronic heart failure who are receiving standard of care in the country. Forxiga is an oral, once-daily sodium-glucose co-transporter 2 inhibitor.
EMA initiates rolling review of Janssen’s Covid-19 vaccine candidate
The European Medicines Agency’s (EMA's) Committee for Medicinal Products for Human Use has initiated a rolling review of Janssen and Cilag International’s Covid-19 vaccine candidate, Ad26.COV2.S. The vaccine candidate has genetic instructions for the spike protein present on the surface of SARS-CoV-2 virus.
US buys additional 650,000 doses of Lilly’s Covid-19 antibody for $812.5m
The US Government has entered into a purchase agreement worth $812.5m to procure 650,000 additional doses of Eli Lilly and Company’s neutralising antibody bamlanivimab (LY-CoV555) 700mg. Developed through collaboration between Lilly and AbCellera, the vaccine candidate is directed against the spike protein of SARS-CoV-2.
NIAID study shows Moderna’s Covid-19 vaccine provides three-month immunity
Researchers at the National Institute for Allergies and Infectious Diseases have reported that Moderna’s Covid-19 vaccine, mRNA-1273, caused the human immune system to produce potent antibodies that endure for at least three months.
Biogen and Sage Therapeutics to co-develop depression and tremor therapies
Biogen and Sage Therapeutics have entered a global collaboration and licence agreement to jointly develop and commercialise depression and tremor therapies, zuranolone (SAGE-217) and SAGE-324, respectively.
Under the deal, Sage will get $1.525bn in cash, which includes an upfront payment of $875m and $650m as an equity investment.
08 December | research
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.
07 December | vaccines
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.
Bangladesh signs Covid-19 vaccine deal with Serum Institute of India
Bangladesh has entered into a deal with the Serum Institute of India (SII) to acquire 30 million doses of a potential vaccine being developed by AstraZeneca for Covid-19. Under the deal, Beximco will purchase five million doses of vaccine per month.
EC approves AstraZeneca and Merck’s Lynparza for two cancer types
AstraZeneca and Merck’s Lynparza (olaparib) has secured approval from the European Commission for prostate cancer and ovarian cancer treatments in the European Union. A subgroup analysis of the PROfound Phase III trial of Lynparza backs the prostate cancer approval.
Australia to acquire 40 million doses of Novavax Covid-19 vaccine
Novavax has signed a non-binding heads of terms document with the Australian Government to supply 40 million doses of its Covid-19 vaccine candidate, NVX-CoV2373. The vaccine candidate is currently in Phase III clinical trial in the UK.
AIIMS find ivermectin prophylaxis reduces infection in Covid-19 patients
A study by All India Institutes of Medical Sciences (AIIMS)-Bhubaneswar in the Indian state of Odisha found that two doses of potential drug ivermectin prophylaxis resulted in a 73% reduction in Covid-19 infection.
Regeneron to continue patient recruitment for Covid-19 trial
The independent data monitoring committee (DMC) has recommended the continuation of Regeneron’s UK-based RECOVERY trial analysing REGN-COV2 in hospitalised patients with Covid-19. Prior to this, DMC recommended holding enrolment for the REGN-COV2 antibody cocktail treatment trials for Covid-19 based on a potential safety signal and an unfavourable risk/benefit profile.