Vaccine

Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

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European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by… Read More »Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

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Shots: The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs. The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response,… Read More »Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

South African variant may cut response from Pfizer/BioNTech shot, study finds

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The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Researchers from the University of Texas Medical Branch based their findings on lab tests using SARS-CoV-2 coronaviruses that were genetically engineered to have the… Read More »South African variant may cut response from Pfizer/BioNTech shot, study finds

AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19

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Shots: WHO has granted EUL to AZ’s vaccine for active immunization to prevent COVID-19 in individuals aged ≥18yrs., including those over 65yrs. EUL granted AZ and SII enabling global access to the vaccine The WHO’s SAGE recommended a dosing interval of 8-12wks. and also recommended… Read More »AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19

Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan

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Shots: Daiichi Sankyo signs an outsourcing Agreement to Manufacture AstraZeneca COVID-19 Vaccine AZD1222 in Japan Following the AstraZeneca’s agreement with the Japanese government to manufacture and supply COVID-19 vaccine, Daiichi Sankyo will use undiluted solutions to manufacture COVID-19 vaccines in the Japan including vial filling… Read More »Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

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Shots: Clover plans to initiate a global P-II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the H1’2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021 Additionally, Clover discontinued their partnership with GSK… Read More »Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

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Shots: The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject to the execution of supply agreements under the Covax Facility structure Covax includes an Advanced Market Commitment (AMC) financial mechanism… Read More »Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

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Shots: The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject to the execution of supply agreements under the Covax Facility structure Covax includes an Advanced Market Commitment (AMC) financial mechanism… Read More »Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing

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The state-owned backers of Russia’s Sputnik V coronavirus vaccine have ruled out a US filing, as talks began in earnest with European regulators over a review. Following a press conference on Thursday morning, the Russian Direct Investment Fund (RDIF), which has been bankrolling the vaccine… Read More »Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing

ConserV Bioscience works on mutation-proof coronavirus shots with US lab

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UK biotech ConserV Bioscience has joined with California’s Lawrence Livermore National Laboratory to develop broad-spectrum coronavirus vaccines as concerns mount over potentially more infectious strains emerging in the UK, South Africa and Brazil. This collaboration brings together ConserV’s expertise in identifying antigens and Lawrence Livermore… Read More »ConserV Bioscience works on mutation-proof coronavirus shots with US lab

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

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Shots: In the agreement, Aurobindo has obtained the exclusive rights to develop, manufacture & sell COVAXX’s UB-612 vaccine in India & UNICEF & also non-exclusive rights in other selected emerging & developing markets UB-612 is presently being assessed in P-I will be manufactured by Aurobindo… Read More »Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

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Shots: The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy The US FDA’s committees… Read More »Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

FDA gives emergency OK to Pfizer and BioNTech vaccine

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The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s White House, renewing concerns that politics drove the vaccine process even as the first doses are shipped.

Sinovac raises $515m to boost production of potential COVID-19 vaccine

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China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. According to press reports Sino Biopharmaceutical, a Hong Kong-listed generics firm, acquired a 15% stake in a subsidiary of Sinovac. Sinovac has… Read More »Sinovac raises $515m to boost production of potential COVID-19 vaccine

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

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Shots: The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety concerns identified to date Moderna plans to submit an EUA to the FDA & an application for CMA with the… Read More »Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

UK appoints COVID-19 vaccine rollout minister as country preps for launch

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The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first… Read More »UK appoints COVID-19 vaccine rollout minister as country preps for launch

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

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Shots: Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273 The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp… Read More »Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

What, Us Worry

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By KIM BELLARD 2020 has been an awful year.  Hurricanes, wildfires, murder hornets, unjustified shootings, a divisive Presidential election, and, of course, a pandemic.  Most of us are spending unprecedented amounts of time sheltering in place, millions have lost their jobs, the economy is sputtering,… Read More »What, Us Worry

Medicare to cover all FDA-approved Covid-19 vaccines

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CMS’ interim rule states that Medicare will cover Covid-19 vaccines approved by the FDA, including those receiving emergency use authorization, in a reversal from its usual policy. The vaccine will be made available at no cost to Medicare beneficiaries.

BCG – COVID-19 Hackathon Challenge Now Extended Through End of Year

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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

CMS promises a plan for Medicare to cover coronavirus vaccine

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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.

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

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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

BCG-COVID 19 Hackathon: Task 1 winners announced, Task 2 – data scientists – we need you!

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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!

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

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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

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

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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

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

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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