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FDA weighs shift in COVID vaccination strategy

Bio Pharma Dive

Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens

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Pfizer begins plan to challenge Shingrix with an mRNA vaccine

Bio Pharma Dive

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine

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Is it time for vaccination mandates?

World of DTC Marketing

29 percent of Americans said they were unlikely to get vaccinated — up from 24 percent three months earlier. Most workers do not want their own employer to require vaccination, including the vast majority of unvaccinated workers (92%). The post Is it time for vaccination mandates?

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The Constitution and vaccinations

World of DTC Marketing

The government has latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” With respect to children, parents do not have carte blanche. The post The Constitution and vaccinations. in the news Vaccinations & the law

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

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FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

Bio Pharma Dive

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults

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The one-shot cervical cancer vaccine paradigm

Pharmaceutical Technology

On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage. The vaccine is also safe, with millions of doses administered globally,” she continues.

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Merck pays $250M to license Moderna cancer vaccine

Bio Pharma Dive

The drugmaker’s decision to grab rights to the shot deepens its ties with the COVID-19 vaccine developer and comes weeks before a key data release

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US speeds rollout of monkeypox vaccine, treatment

Bio Pharma Dive

million doses of the Jynneos vaccine and 50,000 courses of antiviral Tpoxx to states and local governments The Biden administration next week will provide 1.8

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Responding to outbreak, Moderna starts early work on monkeypox vaccine

Bio Pharma Dive

began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus One day after the U.S.

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Profiteering off a Covid vaccine

World of DTC Marketing

SUMMARY: Johnson & Johnson and AstraZeneca publicly committed to not profiting off their products during the pandemic; Pfizer and Moderna made no such pledge and are already planning ways to make more money from their Covid vaccines. The post Profiteering off a Covid vaccine.

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The Covid-19 vaccine numbers game

World of DTC Marketing

SUMMARY: The numbers game for COVOD-19 vaccine makers has started but what most of the public, and the media, don’t understand is that the preliminary numbers don’t mean a damn thing until they are peer-reviewed. As I See It COVID Vaccine

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European regulator recommends Bavarian Nordic's vaccine for monkeypox

Bio Pharma Dive

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines

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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The company stated that the vaccine needs to be used as per official recommendations.

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GSK hires away top Pfizer vaccine scientist

Bio Pharma Dive

Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month

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EMA adds allergic reaction warning to Novavax's COVID-19 vaccine

Bio Pharma Dive

The regulator said there have been “a few” spontaneous severe allergic reactions following administration of the vaccine, which was this week authorized in the U.S.

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Mandating vaccinations is the right decision

World of DTC Marketing

The government has the latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” We, as a nation, can not allow ignorance and stupidity to endanger us all. were for people who skipped out on getting vaccinated.

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Covid vaccine profits and the strain on supply channels

World of DTC Marketing

SUMMARY: Pfizer and Moderna will sell $28 billion of Covid-19 vaccines this year. Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others.

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COVID-19 vaccine maker Medicago to close down

Bio Pharma Dive

The company, which worked with GSK to develop a coronavirus shot, is ceasing operations after its corporate parent cut off further investment

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CureVac sues rival COVID-19 vaccine maker BioNTech for patent infringement

Bio Pharma Dive

The biotech, whose own efforts to develop a COVID-19 vaccine have faltered, claims its inventions were crucial to the development of BioNTech’s top-selling coronavirus shot

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UK, Moderna formalise 10-year vaccines alliance

Pharma Phorum

Construction will start early next year of a new manufacturing centre in the UK with the capacity to produce 250 million vaccine doses per year, the centrepiece of a 10-year alliance between the government and US biotech Moderna.

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Pfizer, BioNTech bet mRNA can make a better shingles vaccine

Bio Pharma Dive

The pharma company, already partnered with BioNTech on vaccines for COVID-19 and influenza, will pay $225 million upfront to further expand its work with the German biotech

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RVAC and University of Pennsylvania to develop mRNA vaccines

Pharmaceutical Technology

RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The partnership will focus on developing potential new vaccines to treat certain selected autoimmune indications, as well as food allergies.

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Moderna sues Pfizer, BioNTech over COVID-19 vaccine technology

Bio Pharma Dive

The biotech claims its rivals’ vaccine Comirnaty, one of the world’s top-selling pharmaceutical products, infringes on two patents covering its messenger RNA technology

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Vaccine from Medicago, GSK protective against COVID-19 in large study

Bio Pharma Dive

The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited

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Consumers fall into three COVID-19 vaccine adoption segments

World of DTC Marketing

(Mckinsey) Much of the prevailing market research on COVID-19 vaccination frames sentiment as “likely,” “unlikely,” or “neutral.” Their research has found that consumers’ attitudes towards receiving a COVID-19 vaccine fall into three primary segments. in the news COVID Vaccine

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CSL closes mRNA vaccine deal with Arcturus

Pharmaceutical Technology

CSL subsidiary CSL Seqirus has closed the international partnership and licence agreement with Arcturus Therapeutics for research, development, production and international marketing of self-amplifying messenger ribonucleic acid (sa-mRNA) vaccines.

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What DTC marketers can learn from people who refuse a COVID vaccination

World of DTC Marketing

SUMMARY: Even though the Delta variant of COVID is highly contagious, people are still choosing not to get vaccinated. Concerns about safety, fear of unknown side effects, and misinformation about COVID-19 are some reasons why people may not accept the vaccine.

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Pfizer forecasts $100B in sales, fueled by COVID-19 vaccine, pill

Bio Pharma Dive

The company estimated revenue from its COVID-19 vaccine and antiviral pill Paxlovid will total $54 billion this year. Curiously, its stock fell by more than 5

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Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda

Bio Pharma Dive

The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales

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FDA names new head to vaccine review office

Bio Pharma Dive

David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters

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Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Bio Pharma Dive

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies

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J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

Bio Pharma Dive

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies

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mRNA can deliver universal flu vaccine, say US researchers

Pharma Phorum

Scientists in the US say they have developed an mRNA-based vaccine that encompasses all 20 known subtypes of influenza that could form the basis of a future universal jab. The goals of the programme are also similar to those in COVID vaccine development.

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UK authorizes AstraZeneca, Oxford coronavirus vaccine, but questions linger

Bio Pharma Dive

The first public vaccinations with AstraZeneca and Oxford’s shot will begin early in the New Year. But it’s still unclear how effective the vaccine is, or the best way to use it

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Pfizer set to double weekly production of coronavirus vaccine

Bio Pharma Dive

The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday

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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]).

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Health Canada approves Novavax’s Covid-19 vaccine for adolescents

Pharmaceutical Technology

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. Homologous boosting with the vaccine in adults was approved in November.

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J&J's coronavirus vaccine faces new US limits

Bio Pharma Dive

Days after the FDA strengthened safety warnings for the company's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred" over J&J's

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FDA grants full approval to Pfizer, BioNTech's coronavirus vaccine

Bio Pharma Dive

The long-awaited decision could strengthen the case for vaccine mandates as public health officials seek to boost rates of immunization amid a wave of COVID-19 cases

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Tracking the FDA's meeting on Pfizer's vaccine for kids

Bio Pharma Dive

Outside experts are reviewing Pfizer's application for emergency authorization of its vaccine in 5- to 11-year-olds. Follow their discussion with BioPharma Dive reporters live

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FDA authorizes J&J's one-shot coronavirus vaccine

Bio Pharma Dive

The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time

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FDA starts speedy review of Takeda’s dengue vaccine

Pharma Phorum

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. Takeda said last year that the vaccine could reach up to $1.6