A renewed interest in whether the BCG vaccine (for tuberculosis) could also have an application for COVID-19 has been on the rise, as evidenced by this recent Cell publication, the University of Exeter’s involvement in the BRACE Trial and ongoing general press coverage. Furthermore, the list of clinical trials focusing… Read More »BCG – COVID-19 Hackathon Challenge Now Extended Through End of Year
Merck & Co has built more momentum behind its attempt to depose Pfizer’s blockbuster pneumococcal conjugate vaccine Prevnar 13, with two new phase 3 trials backing its rival shot V114. The two trials are both in adult subjects, a group that has been driving growth… Read More »Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13
AstraZeneca’s COVID-19 vaccine trial could be ready to resume this week in the US after a seven-week hiatus while the FDA completed its review of a serious illness, according to reports. Citing four sources, Reuters said that the FDA is about to allow the large-scale… Read More »AZ’s COVID-19 vaccine trial ready to resume – reports
The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has… Read More »UK government signs contract for COVID-19 challenge trial
Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late… Read More »Pfizer to wait until after election to file COVID-19 vaccine in US
Medicare doesn’t currently cover drugs approved under emergency use designations. But CMS Administrator Seema Verma said the agency was coming up with a plan to make sure Medicare beneficiaries were covered once a coronavirus vaccine is developed.
Shots: GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on March 27, 2020). The equity investment and collaboration will complete at the same time & are conditional upon customary conditions… Read More »GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses
Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work… Read More »BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2
The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. The announcement comes just days after the regulator said its CHMP scientific… Read More »Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab
As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease. According to weekend press reports… Read More »Older people first to receive COVID-19 vaccine in UK, says government
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines… Read More »European regulators begin rolling review of AZ’s COVID-19 vaccine
We’ve seen the scientific community come together time and again throughout the COVID-19 pandemic, and we’re thrilled to have been part of a hackathon bringing together data scientists, epidemiologists and partner organizations focusing on analysing the hypothesis of whether the tuberculosis (TB) vaccine – BCG… Read More »BCG-COVID 19 Hackathon: Task 1 winners announced, Task 2 – data scientists – we need you!
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Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the… Read More »Pfizer/BioNTech say COVID-19 jab on track for approval by year-end
Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the… Read More »Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020
Shots: mAbxience will produce ~200M + doses of AZD1222 and will supply it to all Latin American countries, except Brazil The company will produce API in its facility located in Garín (Argentina) and will send it to Mexico to complete the production and filling process.… Read More »AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America
Shots: The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine has proven safe and effective. The agreement includes an option to purchase up to an additional 200M dose If approved,… Read More »EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine
Shots: AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region The price for the vaccine is not final but it is expected not to exceed $4/ dose.… Read More »AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021
Russia has become the first country in the world to approve a coronavirus vaccine, amid scepticism from international experts who have been unable to review or verify clinical data from the jab called ‘Sputnik V’. According to press reports the vaccine has been tested on… Read More »Scepticism as Russia claims coronavirus vaccine breakthrough with Sputnik V
Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B
Shots: The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating… Read More »Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B
Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created… Read More »Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development
Shots: The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine The US government has an option to… Read More »Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine
The US government has selected a potential vaccine from Sanofi and GlaxoSmithKline for its Operation Warp Speed COVID-19 vaccine development initiative, committing up to $2.1 billion for an initial 100 million doses. The collaborative effort with the US government will accelerate the development and manufacturing… Read More »US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine
Shots: The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19 Sanofi leads the clinical development and registration of the vaccine and expects a P-I/II study to be initiated in Sept’2020, followed by a P-III… Read More »Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine
Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19
Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate… Read More »Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19
A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab. The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483… Read More »Moderna gets further $472m as expanded phase 3 COVID-19 trial begins
The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials. There is no approved COVID-19 vaccine, but governments across the world are busy signing deals with developers to gain access should trial results… Read More »UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva
Press reports suggest that there is good news about AstraZeneca and Oxford University’s COVID-19 vaccine due from an early stage trial in the coming days – but the focus is moving on how to get the in-depth safety and efficacy results needed to get the… Read More »Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout
The health authorities have time and again requested people not to take any drug or medicines by themselves in an attempt to cure coronavirus. When something is available for the treatment of COVID-19, it will be publicly announced by the World Health Organization (WHO). The… Read More »No Approved Drug or Chemical For Prevention and Treatment of Coronavirus