Mobilizing against monkeypox
As the world continues to navigate Covid and its many strains, it would be an understatement to say that everyone is on high alert for […]
Vaccine
First monkeypox deaths outside Africa recorded
Monkeypox has claimed the first lives outside Africa – one in Brazil and another two in Spain – although the World Health organization (WHO) has […]
Record Shingrix sales help GSK raise 2022 forecasts
In its first set of financial figures since spinning off its consumer health division, GSK has reported a 19% increase in revenues, driven by burgeoning […]
Nation’s largest nurses union calls on Biden administration to tighten COVID-19 restrictions
The country’s largest union of registered nurses called on the Biden administration to take action against rising COVID-19 cases and hospitalizations amid the surge of […]
DC has highest number of monkeypox cases nationally per capita
The nation’s capital has the highest number of monkeypox cases per capita, with 122 confirmed cases as of Sunday, health officials reported on Monday. According […]
White House COVID-19 coordinator says virus ‘still evolving rapidly’ from transcript
As variants continue to circulate and develop, White House COVID-19 response coordinator Ashish Jha says the U.S. has “got to stay on top of this […]
Amazon, research center partner on cancer vaccine
Amazon will collaborate with the Fred Hutchinson Cancer Center in Seattle on an FDA-approved clinical trial for a cancer vaccine. According to a filing with […]
NIH starts trial of Moderna’s mRNA Nipah virus vaccine
Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality […]
Monkeypox cases in New York City double in past week
The number of confirmed monkeypox cases in New York City has doubled in the past week, according to data from the city’s Department of Health […]
Pfizer seeks to overturn three RSV vaccine patents held by GSK
Already competing to bring the first vaccine against respiratory syncytial virus (RSV) to market, Pfizer and GSK are also fighting a patent infringement battle in […]
Merck ups the stakes in pneumococcal jab face-off with Pfizer
Dominance of the pneumococcal vaccine category is a race between Merck & Co and Pfizer, and while the latter is comfortably in front at the […]
Pfizer takes stake in French Lyme disease jab partner Valneva
Pfizer has acquired an 8.1% stake in French vaccines developer Valneva at a cost of €90.5 million (around $95 million) and rejigged the terms of […]
Takeda bolsters data for dengue jab as regulatory reviews roll on
Takeda has reported positive new, long-term results in its pivotal trial of dengue fever vaccine TAK-003 that builds the case for the shot as regulators […]
Relief for GSK as RSV vaccine clears phase 3 test in adults
GSK will start preparations for regulatory filings of its respiratory syncytial virus (RSV) vaccine straight away, after the shot hit the mark in the much-anticipated […]
White House unveils plans to roll out COVID-19 vaccines for kids 5 and under
Ten million pediatric COVID-19 vaccine doses will be available for states, Tribes and other jurisdictions to pre-order in anticipation of vaccinations for kids ages 5 […]
FDA clears GSK’s Priorix, first new MMR vaccine in 50 years
With vaccine hesitancy leading to a rise in measles cases, the FDA’s approval of GlaxoSmithKline’s venerable vaccine Priorix for sale in the US looks timely. […]
GSK bolsters vaccines division with $3.3bn swoop on Affinivax
GlaxoSmithKline has agreed a $3.3 billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that […]
Monkeypox cases are rising. Should we be worried?
The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan Africa, with cases rising above the 100-mark […]
Moderna’s HIV vaccine prepped for trials in Africa
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of […]
2nd Annual mRNA-Based Therapeutics Summit
Do you want to be part of the largest gathering of mRNA professionals? The 2nd Annual mRNA-Based Therapeutics Summit is returning in-person to Boston this July 26-28. Expect exclusive data from […]
J&J ducks out of Bavarian Nordic vaccine partnerships
Johnson & Johnson has halved the size of its collaboration with Bavarian Nordic on vaccine development, jettisoning its stake in shots targeting human papillomavirus (HPV) […]
Moderna asks FDA to authorize vaccine for kids under 6
Moderna on Thursday asked the Food and Drug Administration to authorize its vaccine for children under six years of age, becoming the first company to […]
Readout sets up phase 3 for Valneva/Pfizer’s Lyme disease jab
There’s only one vaccine candidate for tick-borne infection Lyme disease in clinical development – Valneva and Pfizer’s VLA15 – and it has just moved another […]
Clyburn requests briefing on status of COVID vaccines for young kids
House Majority Whip James Clyburn (D-S.C.) on Monday requested a briefing from the Food and Drug Administration (FDA) on the status of COVID-19 vaccines for […]
Next Generation RNA Therapeutics Summit
Are you looking to solve challenges with current RNA therapeutics, such as the degradation of RNA by RNAses, the difficulty of RNA crossing the cell […]
Moderna: Dual variant booster with beta more effective against omicron than current formula
Moderna on Tuesday said new clinical data had found that its bivalent COVID-19 booster shot was more effective against all variants of concern when compared […]
AXA beefs up life sciences investments with $500m push
Multinational insurance company AXA has launched a new €440 million ($500 million) drive to provide private equity investments in healthcare companies that deepens its interest […]
Trailing its RSV vaccine rivals, Bavarian Nordic cuts China deal
Bavarian Nordic has licensed rights to its respiratory syncytial virus (RSV) vaccine in China and certain other Asian markets to Shanghai’s Nuance Pharma in a […]
Does the pandemic mark a turning point in vaccine development?
After a period where vaccine development had fallen away, suddenly it is back in the limelight. Investment has flowed back into the sector and Ben […]
Welcome to the 2nd Chronic HBV Drug Development Summit
Advance Combination Therapies, Outline Clinical Endpoints & Understand the Immunology Perspective to Achieve Functional Cures for Chronic Hepatitis B. With a tight lens on late […]
After GSK stumble, Pfizer moves forward with RSV vaccine
Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position […]
Pfizer’s seeks silver lining in failed C. diff vaccine trial
Pfizer’s vaccine for Clostridium difficile (C. diff) looks like it may join a growing list of candidates that have been shelved or delayed, after the […]
GSK’s halts RSV vaccine trials in pregnant women after pause
It looks like GlaxoSmithKline’s concerns about its respiratory syncytial virus (RSV) vaccine in pregnant women aren’t going to be resolved quickly. After suspending three trials […]
Safety probe prompts GSK to halt RSV jab study in pregnant women
GlaxoSmithKline has a lot riding on its respiratory syncytial virus (RSV) vaccine, which it thinks could be a $4 billion product at peak, so investors […]
Vaccines upstart Curevo has designs on blockbuster GSK franchise
Seattle, US vaccine startup Curevo has raised $60 million in first-round financing that it says will be used to run head-to-head trials of its experimental […]
Digital innovation drives vaccine development
It is becoming increasingly important for people all over the world to understand the importance of vaccines and to have access to the vaccines they […]
Covid vaccine booster raises antibody levels in fight against Omicron
A third dose of vaccine has been shown to effectively neutralise the Omicron variant of covid-19, according to researchers. Research led by UCLH, UCL and […]
Japan approves Pfizer COVID vaccine for children aged 5 to 11
Japan’s health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11. The vaccine, Comirnaty, is claimed […]
Nine for 2022: innovation and opportunities in healthcare
In the second part of our examination of issues that will shape the course of 2022, we’ll update the ongoing impacts of the pandemic, which […]
Look out GSK, Pfizer and BioNTech are coming for Shingrix
GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. Now, Pfizer and BioNTech are joining forces […]
Nine for 2022: International issues that are compelling, new or changed in 2022
The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a […]
Sanofi snaps up acne vaccine developer Origimm Bio
Sanofi has added to its vaccine pipeline with an agreement to acquire Austria’s Origimm Biotechnology and its vaccine-based immunotherapy for people with acne. The French […]
Report suggests UK’s national vaccine facility is on the block
The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) – unveiled with fanfare by the government in 2018 – is rumoured to be up for sale. […]
Trial of intranasal Alzheimer’s vaccine gets underway in US
The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow […]
Vaccibody rebrands as Nykode, and unveils big Regeneron partnership
Norwegian biotech Vaccibody has changed its name to Nykode Therapeutics, and celebrated its new identity with a sizeable deal with Regeneron to develop vaccines for […]
Study shows HPV jab almost 90% effective at preventing cervical cancer
Routine vaccination with human papillomavirus vaccines have resulted in an 87% reduction in cervical cancer cases in England, and could even see the need for […]
9 Ways Pharmacists Are Helping the Community
You may not realize it, but your community pharmacist does so much more than fill the prescriptions your primary healthcare provider writes for you. In […]
9 Ways Pharmacists Are Helping the Community
You may not realize it, but your community pharmacist does so much more than fill the prescriptions your primary healthcare provider writes for you. In […]
The “Secret Sauce” – A Comparison of TSMC and Pfizer
By MIKE MAGEE This week’s Tom Friedman Opinion piece in the New York Times contained a title impossible to ignore: “China’s Bullying Is Becoming a Danger […]
GSK’s malaria vaccine gets WHO okay for mass rollout
The WHO has given a green light to widespread use of GlaxoSmithKline’s malaria vaccine in Africa, in what could be a major turning point in […]
Epic deploys Covid-19 vaccine credential feature
Epic’s Covid-19 vaccine credential, which shows up as a QR code within the MyChart patient portal, can be used to verify a person’s immunization status. […]
Booster data backs Pfizer, Valneva Lyme disease vaccine
Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of […]
Contact-tracing apps ‘could improve COVID vaccination strategy’
Targeting people for COVID-19 vaccination using contract-tracing apps could be a shortcut to achieving herd immunity in the population using fewer doses, according to Canadian […]
Analysis: Cost of care for unvaccinated Covid patients spikes to $5.7B
The cost of hospital care for unvaccinated Covid-19 patients has more than doubled, jumping from about $2 billion to $5.7 billion over the summer. And […]
As Delta surges, CMIOs’ focus on plans to provide vaccine booster shots, fight false information
Chief medical information officers are in a unique position to help their organizations fight the Covid-19 pandemic — from setting up IT systems to support […]
Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial
Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to […]
Merck raises pressure on Pfizer in pneumococcal vaccine tussle
Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that […]
Analysis: Care for the unvaccinated may be costing U.S. healthcare system $2.3B
The report, released by Kaiser Family Foundation and the Peterson Center on Healthcare, details the high cost of Covid care for the unvaccinated. In fact, […]
Providers will likely face more lawsuits against vaccine mandates. But they are also more likely to win.
Providers’ legal defense against lawsuits aiming to tear down vaccine mandates is wide-ranging, from making the argument that allowing an unvaccinated worker into their facilities […]
Boost vaccination rates with frictionless self-scheduling
It’s time to accelerate the pace of COVID-19 vaccinations. Healthcare experts are increasingly concerned about the rapid spread of the highly contagious delta variant, which […]
Boost vaccination rates with frictionless self-scheduling
As the country strives to ramp up the pace of COVID-19 vaccinations, providers need to take new approaches to drive registration volume. Healthcare experts are […]
Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn
Sanofi has been forging ever-closer ties with its mRNA partner Translate Bio since the two started working together in 2018, and has now gone all […]
Takeda spins norovirus vaccine out into separate company
Takeda has decided development of its norovirus vaccine candidate outside Japan will be more efficient if it is spun out into a dedicated company. The […]
Medicare vaccine coverage (including how the COVID-19 vaccines are covered)
How does Medicare cover vaccines? Are the paid for by Medicare Part B or Part D? MedPAC’s June 2021 report provides a nice overview. Medicare […]
World Hepatitis Day 2021
Every 30 seconds, a person dies from a hepatitis-related illness. This terrible death toll is why the mantra for World Hepatitis Day (July 28) this […]
Shot in the arm for Affinivax as it challenges Pfizer’s Prevnar
Already facing one rival to its blockbuster pneumococcal vaccine Prevnar, Pfizer could have another to contend with, after Affinivax reported positive phase 2 results with […]
Moderna plans triple vaccine targeting flu, COVID and RSV
Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different […]
COVID-19 vaccine development: Safety monitoring continues revolution in RWD
From cancer to COVID, real-world data is changing the way we research therapeutics, monitor safety, and collaborate on the development of treatments designed to improve […]
COVID-19 vaccine development: Safety monitoring continues revolution in RWD
From cancer to COVID, real-world data is changing the way we research therapeutics, monitor safety, and collaborate on the development of treatments designed to improve […]
AstraZeneca’s COVID-19 Vaccine Demonstrates 92% Efficacy Against Delta (Indian) Variant
Shots: Real world data from PHE demonstrated two doses of AZ’s vaccine are 92% effective against hospitalization due to the Delta variant and showed no […]
Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents
Shots: The P-II/III TeenCOVE study involves assessing mRNA-1273 (two 100 µg doses) vs PBO in 3700+ participants in a ratio (2:1) aged 12 to <18yrs. […]
Japan approves two more COVID vaccines as fourth infection wave hits
Japan has approved two more coronavirus vaccines, while expanding a state of emergency to cover the southern island of Okinawa. The two newly approved vaccines […]
Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan
Shots: MHLW has granted special approval under article 14-3 of the PMDA for emergency use of Moderna’s mRNA COVID-19 vaccine based on Takeda’s P-I/II immunogenicity […]
HIV Vaccine Awareness Day
The global focus on the development and distribution of COVID-19 vaccines over the past year has been a reminder that there are still many other […]
Sanofi/GSK move latecomer COVID-19 shot into phase 3
Sanofi and GlaxoSmithKline seem to be getting somewhere with their COVID-19 vaccine at last, announcing plans to move to phase 3 following supportive mid-stage trial […]
Sanofi and GSK Report Results of its COVID-19 Vaccine in a P-II Study Across All Adult Age Groups
Shots: The vaccine has achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all […]
Novavax delays COVID vaccine filings until Q3
Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are […]
FDA authorises Pfizer/BioNTech vaccine for adolescents
The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s […]
Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix
Coronavirus won’t be circulating in the UK by August, according to the outgoing chief of the country’s vaccine rollout scheme, Dr Clive Dix. Dix led […]
Pfizer shares slump as support grows for COVID-19 vaccine patent waiver
Shares in COVID-19 vaccine manufacturers have taken a hit after the US signalled its support for waiving patents on them, a moved aimed to boost […]
EU starts rolling review of Sinovac’s COVID-19 vaccine
Europe’s regulator has begun a rolling review of Sinovac’s COVID-19 vaccine, known as Vero Cell. The vaccine is based on an inactivated SARS-CoV-2 virus, which […]
UK orders 60m ‘booster’ doses of Pfizer/BioNTech COVID vaccine
The UK has ordered an extra 60 million doses of the Pfizer/BioNTech COVID-19 vaccine, which could be used as a potential booster campaign in the […]
European Commission legal battle with AZ over COVD vaccines contract
The European Commission has officially begun legal proceedings against AstraZeneca over supplies of COVID vaccines. The legal action marks an escalation in the dispute between […]
Oxford’s malaria shot set for phase 3 test after ‘unprecedented’ 77% efficacy
Following the success of the coronavirus vaccine developed with AstraZeneca, Oxford University’s Jenner Institute has unveiled trial results showing its experimental malaria shot could be […]
EU safety regulators clear J&J COVID shot despite tiny clot risk
The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. In a decision […]
Risk of brain clots higher with COVID than vaccine, study suggests
A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those […]
Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots
The Czech Republic wants to buy around 2.4 million doses of the AstraZeneca/Oxford University vaccine ditched by Denmark, which has said it will stop using […]
J&J Pauses Dosing of COVID-19 Vaccine Due to Blood Clotting
Shots: J&J temporarily pause the use of the COVID-19 vaccine in the US, following recommended of the CDC and FDA. The review data involves six […]
England begins Moderna vaccine rollout as lockdown eases
England is beginning its rollout of the Moderna COVID-19 vaccine, offering an alternative to the AstraZeneca/Oxford University jab following a potential link to a very […]
South African variant may evade Pfizer/BioNTech vaccine, study finds
The coronavirus variant discovered in South Africa may evade Pfizer/BioNTech’s vaccine, according to a real-world data study conducted in Israel. Known as variant B.1.351, the […]
Poll: About half of healthcare workers feel burned out, anxious when going to work
Though a majority of healthcare workers believe that the pandemic is at least somewhat under control now, about half still feel anxious or burned out […]
World leaders call for international pandemic preparedness treaty
More than 20 world leaders have called for an international treaty for pandemic preparedness to protect the world from future health crises. Backed by the […]
EU stops short of vaccine export controls after summit
The European Union has stopped short of export controls on vaccines after leaders met at a summit to discuss the issue of shortfalls in supply. […]
AZ issues revised efficacy figures for COVID-19 shot
AstraZeneca has issued revised efficacy figures from the US trial of its COVID-19 vaccine following a complaint from independent monitors that figures from an interim […]
Cell-Mediated Therapies for Infectious Disease Summit
In the fight against emerging coronavirus variants and spike mutations, the need for long-lasting immunity is greater than ever. This is why the time is […]
Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show
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 […]
EU probes low platelet safety issue with COVID-19 shots
EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. […]
J&J manufacturing delays hit US vaccine rollout
The rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & […]
Austria safety officials suspend batch of AZ vaccines after death
Austrian health officials have withdrawn a batch of Oxford University/AstraZeneca’s COVID-19 vaccine after two cases of severe coagulation, one of which was fatal. Both patients […]
Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan
Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing […]
Budget 2021: Sunak focuses on vaccine development to restart economy
UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with […]
‘Vaccine, vaccine’: Dolly Parton urges Americans to get COVID-19 shots
Efforts to encourage US citizens to take their COVID-19 vaccines received a boost from country music legend Dolly Parton, who updated her hit song “Jolene” […]
Novavax in talks with FDA over quick approval for COVID-19 shot
Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the […]
Genetic Vaccine Development for Infectious Diseases Summit
The COVID-19 pandemic brought life-changing disruptions to people around the world and has turned the typical vaccine R&D process on its head. A combination of […]
Data back use of AZ and Pfizer COVID-19 vaccines in older people
Both the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines are highly effective in reducing COVID-19 infections among older people, according to an emerging study data. Data […]
How advanced technology can streamline the COVID-19 vaccine rollout
Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. While the rollout […]
Johnson & Johnson Receives the US FDA’s EUA for COVID-19 Vaccine
Shots: The FDA has issued a EUA for a single-shot COVID-19 vaccine to prevent COVID-19 in individuals aged ≥18yrs. The company plans to file BLA […]
AZ sells stake in Moderna for more than $1billion
AstraZeneca has sold its stake in Moderna for more than $1 billion as the US biotech’s shares soared in value following its coronavirus vaccine breakthrough. […]
Altimmune begins trial of nasal vaccine for COVID-19
Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. Maryland, […]
Pfizer files tick-borne encephalitis shot with FDA
Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is […]
COVAX vaccine-sharing scheme delivers first COVID shots to Ghana
The first deliveries of vaccines from the World Health Organization-backed COVAX initiative, which aims to ensure access in low income countries, has arrived. A shipment […]
FDA guidance allows fast updates of COVID-19 vaccines
The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging […]
AZ to divert COVID-19 vaccines from global supply chain to meet EU target
AstraZeneca has said it will be able meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping […]
Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine
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 […]
Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation
Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase […]
Novavax provides 1.1 billion COVID shots to global vaccine drive
Novavax has signed a deal to provide 1.1 billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, […]
South African variant may cut response from Pfizer/BioNTech shot, study finds
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 […]
Livi fights anti-vaxxers with digital patient messaging campaign
Digital health firm Livi is planning to step up its digital campaign to encourage people to get their COVID-19 vaccines in the UK, with messaging […]
Europe orders another 200m doses of Pfizer/BioNTech COVID shot
The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. Under […]
AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19
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 […]
Guinea declares Ebola epidemic following first deaths since 2016
Guinea has officially declared it is dealing with an Ebola epidemic, after at least three people died from the virus. The BBC reported that these […]
UK government mulls lockdown review as it hits 15m COVID vaccine target
More than 15 million people in the UK have had their first coronavirus vaccine, described as a ‘significant milestone’ by prime minister Boris Johnson. While […]
Early data back J&J and AC Immune’s Alzheimer’s jab
Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a […]
AZ’s next-generation COVID-19 vaccine could be ready in autumn
AstraZeneca is aiming to get a next-generation vaccine targeting emerging variants approved and into the arms of patients by the autumn, company representatives said in […]
EU finalises order for 300 million more Pfizer/BioNTech COVID-19 shots
The European Union has rubber-stamped its order for a further 300 million doses of Pfizer/BioNTech’s COVID-19 vaccine, according to press reports. Citing a European Commission […]
China approves Sinovac’s coronavirus vaccine
China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical […]
Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan
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 […]
J&J seeks emergency use for Covid-19 vaccine, FDA advisory panel is next
Johnson & Johnson’s Covid-19 vaccine offers storage and distribution advantages compared to mRNA vaccines, and is the only single-shot vaccine to reach late-stage testing. The […]
J&J asks FDA for emergence clearance for single-shot COVID-19 vaccine
Johnson & Johnson’s Janssen unit has filed its single dose COVID-19 vaccine candidate with the FDA, asking for an Emergency Use Authorization (EUA). The EUA […]
UK reaches 10 million landmark with COVID-19 vaccination programme
The UK has reached a major landmark with its COVID-19 vaccination programme, with more than 10 million people receiving their first shot. After almost a […]
Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan
Shots: The Taiwan Ministry of Health and Welfare granted conditional approval to initiate P-II trial of UB-612 in 3,850 subjects including adolescents, adults, and seniors […]
Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate
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 […]
Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine
Shots: Gristone to receive $60M at closing, including $30M up front and a $30M as an equity investment at a premium and is eligible to […]
AstraZeneca to supply nine million more vaccines to EU
The diplomatic row that broke out last week over the supply of AstraZeneca’s vaccine to Europe appears to have cooled after the UK pharma agreed […]
AZ has ‘constructive talks’ with EU leaders after vaccine row
AstraZeneca has said it has had “constructive talks” with European leaders in a bid to cool the row over vaccine supplies to the EU. The […]
Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot
Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The […]
US Merck axes two COVID-19 vaccines, focuses on therapies instead
Merck & Co is to axe development of two COVID-19 vaccine candidates, focusing on development of two therapies instead following disappointing results in early trials. […]
Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19
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 […]
Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19
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 […]
Companies vie for a role in federal vaccine plans — and for their workers to get vaccinated
Amazon, Walmart, Starbucks and other retailers are offering to play a bigger role in helping distribute Covid-19 vaccines. In most states, essential workers are still […]
Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing
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 […]
ConserV Bioscience works on mutation-proof coronavirus shots with US lab
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 […]
One in 11 over-65s unwilling to take COVID-19 shot
One in 11 adults aged over 65 have reported a lack of willingness to receive a COVID-19 vaccine, according to a US-based survey. The findings […]
COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in
Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic. As vaccine manufacturers face […]
J&J single-shot COVID-19 vaccine shows early promise
J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial […]
YouTube teams up with providers, healthcare groups to combat health misinformation
The video-sharing giant is partnering with providers and groups, like Mayo Clinic and the American Public Health Association, to create evidence-based health content. YouTube has […]
IO Biotech raises $155m to develop breakthrough cancer vaccine
IO Biotech, an oncology specialist formed and backed by Denmark’s Novo Holdings, has raised €127 million ($155 million) to further develop its cancer vaccine technology […]
Some much-needed help: HHS doles out $22B for testing, vaccines
States will get some much needed support to roll out a coronavirus vaccine. Last week, the Department of Health and Human Services shared it would […]
UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens
The UK government has promised a “massive uplift” in the number of coronavirus vaccinations carried out this week, while conceding a target of 13.9 million […]
FDA and doctors warn against extending COVID-19 vaccine dose gap
Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK […]
Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine
Shots: Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use Following an agreement to […]
Anthem, Epic join Lyft to launch Covid-19 vaccine access campaign
Rideshare app Lyft is partnering with corporations and healthcare organizations to create an initiative that will help connect members of underserved communities to vaccination sites […]
Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF
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 […]
UK prepares for decision on AZ/Oxford vaccine as COVID cases soar
The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford […]
‘Highly likely’ BioNTech vaccine will work against new strain, says CEO
BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the […]
Moderna and BioNTech – who are they?
Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these […]
NHS pilots virtual assistant for flu jab bookings
More than 1,000 NHS patients have booked flu vaccinations using a virtual assistant as part of a pilot project in the south east of England. […]
FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote
The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted […]
Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19
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 […]
COVID-19 vaccine distribution: 4 ways providers can win with online self-scheduling
It’s been almost an entire year since COVID-19 changed life as we know it. The good news? A vaccine has finally arrived and is currently […]
Trials of Valneva COVID-19 vaccine begin in UK
Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s […]
Minervax raises €47.4m in Series B funding round for GBS shot
Denmark’s MinervaX has raised €47.4 million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into […]
Family doctors begin COVID-19 immunisation drive in UK
The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking […]
FDA gives emergency OK to Pfizer and BioNTech vaccine
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 […]
Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months
Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially […]
FDA advisers vote in favour of Pfizer/BioNTech COVID-19 shot
Advisers to the FDA have voted in favour of approving Pfizer and BioNTech’s COVID-19 vaccine, with a near-unanimous backing from an expert committee. While the […]
QliqSOFT, CPSI to offer Covid-19 vaccine chatbot to community hospitals
The COVID-19 Vaccination Assistant will provide information about the new vaccines to help allay fears among the U.S. public. It will also help people schedule […]
Coronavirus vaccine may have allergy warning in US, says expert
The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone […]
CO2 Safety Monitors for Dry Ice Vaccination
Ormond Beach, FL – CO2Meter, Inc. has partnered with a national pharmacy chain to keep their customers and employees safe from the potential hazardous effects […]
FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel
Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that […]
Sinovac raises $515m to boost production of potential COVID-19 vaccine
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 […]
UK faces “V-Day” and largest ever vaccination programme
Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a […]
Valneva accelerates Lyme disease vaccine R&D project with Pfizer
Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter […]
Pfizer cut vaccine production targets because of raw material shortage – reports
Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The […]
The known unknowns of COVID-19 vaccines
News that COVID-19 vaccines are up to 95 per cent effective has scientists cautiously optimistic. But questions remain. “There’s a long list of things we […]
Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval
Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world […]
Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end
Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the […]
Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study
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 […]
Vaccine nationalism, CDMO expansion, AMR and dual sourcing predicted in 2021
The new report looks ahead to a post-pandemic 2021 with pharma manufacturing capacity and payment structures shifting as new sourcing strategies emerge Amsterdam: A new […]
UK appoints COVID-19 vaccine rollout minister as country preps for launch
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 […]
Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine
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 […]
AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review
AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial […]
Brexit could hinder access to coronavirus vaccines, says pharma group
The UK’s pharma industry trade body has warned that Brexit could derail the government’s efforts to get coronavirus vaccines to the population, but welcomed other […]
What, Us Worry
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 […]
‘Mistake’ led to AZ’s more effective lower-dose COVID-19 shot
AstraZeneca’s research chief has said that the more effective dosing regimen of its coronavirus vaccine was discovered by accident. According to Reuters, the AstraZeneca development […]
AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19
Shots: Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and […]
AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival
AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the […]
Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing
Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. The […]
Pfizer prepares to file COVID-19 shot after reaching safety milestone
Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press […]
Pfizer begins US pilot delivery programme for COVID-19 vaccine
Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by […]
COVID-19 vaccine: More good news as Moderna releases results
Looks like more good news on the COVID-19 vaccine front. Dr. Fauci’s prediction that the Pfizer/BioNTech foreshadowed positive news for future vaccines appears to have […]
CMS to cover Covid-19 antibody treatments, but obstacles to use remain
CMS will cover monoclonal antibody treatments for Medicare beneficiaries with Covid-19. Though this is a step forward in increasing access to these treatments, there are […]
J&J begins trial of two-dose COVID-19 vaccine regimen
Johnson & Johnson has begun a second phase 3 trial of its potential COVID-19 vaccine, including sites in the UK, testing whether it works as […]
Hungary steps out of line with EU to order Russia’s COVID-19 vaccine
Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate. According to press reports, […]
GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine
Shots: Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant The study will evaluate the […]
EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine
The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% […]
J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU
Shots: J&J has resumed recruitment, enrolment, and vaccination in all studies of its COVID-19 vaccine across the EU, after a temporary pause. Trials in the […]
NHS set to roll out COVID-19 shot in New Year, says health secretary
The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock. In […]
Divided Congress paves way for drug price reforms on Biden’s watch
Unless president Donald Trump is successful with legal challenges, Democratic rival Joe Biden looks to have won the White House in last week’s election but […]
Positive news on a COVID-19 vaccine
Great news on progress for a COVID-19 vaccine from Pfizer. From their press release: Vaccine candidate was found to be more than 90% effective in […]
Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients
As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering […]
Drugs and vaccines may not swiftly end pandemic, says Merck & Co’s CEO
Merck & Co’s CEO Kenneth Frazier has warned that the drugs and vaccines in the pipeline to combat COVID-19 may not be enough to swiftly […]
Medicare to cover all FDA-approved Covid-19 vaccines
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 […]
BCG – COVID-19 Hackathon Challenge Now Extended Through End of Year
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 […]
Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13
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 […]
AZ’s COVID-19 vaccine trial ready to resume – reports
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 […]
UK government signs contract for COVID-19 challenge trial
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 […]
Pfizer to wait until after election to file COVID-19 vaccine in US
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 […]
CMS promises a plan for Medicare to cover coronavirus vaccine
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 […]
GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses
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 […]
BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2
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 […]
Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab
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 […]
Older people first to receive COVID-19 vaccine in UK, says government
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 […]
European regulators begin rolling review of AZ’s COVID-19 vaccine
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. […]
BCG-COVID 19 Hackathon: Task 1 winners announced, Task 2 – data scientists – we need you!
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 […]
2 billion vials. Public acceptance. The obstacles to vaccine delivery
The post 2 billion vials. Public acceptance. The obstacles to vaccine delivery appeared first on Healthy Debate.
COVID-19 vaccines in the making
The post COVID-19 vaccines in the making appeared first on Healthy Debate.
Pfizer/BioNTech say COVID-19 jab on track for approval by year-end
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 […]
Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020
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 […]
AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America
Shots: mAbxience will produce ~200M + doses of AZD1222 and will supply it to all Latin American countries, except Brazil The company will produce API […]
EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine
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 […]
AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021
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 […]
Scepticism as Russia claims coronavirus vaccine breakthrough with Sputnik V
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 […]
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 […]
Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development
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 […]
Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine
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 […]
US pays $2.1bn to Sanofi/GSK for 100 million 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 […]
Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M 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 […]
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 […]
Moderna gets further $472m as expanded phase 3 COVID-19 trial begins
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 […]
UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva
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 […]
Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout
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 […]
No Approved Drug or Chemical For Prevention and Treatment of Coronavirus
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 […]
