Bio Pharma Dive

DECEMBER 30, 2020

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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Pharmaceutical Technology

FEBRUARY 12, 2024

vaccine targeting Omicron variant. The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5

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Vaccine Vaccination 357

Bio Pharma Dive

FEBRUARY 19, 2021

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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Production Vaccine Vaccination 357

Bio Pharma Dive

AUGUST 27, 2020

Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.

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Vaccine Vaccination Trials 361

Bio Pharma Dive

FEBRUARY 27, 2021

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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Vaccine Vaccination 351

Bio Pharma Dive

JANUARY 25, 2021

The drugmaker, one of the largest vaccine developers globally, won't move forward with either of two candidates it's been testing after disappointing data in early trials.

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Vaccine Vaccination Development Trials 350

Bio Pharma Dive

JANUARY 28, 2021

So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.

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Vaccine Vaccination 356

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5

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Bio Pharma Dive

JULY 22, 2022

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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Regulation Vaccine Vaccination Medicine 343

Bio Pharma Dive

FEBRUARY 9, 2021

Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots?

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Vaccine Vaccination 364

Bio Pharma Dive

AUGUST 26, 2020

An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.

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Immune Response Vaccine Vaccination 363

Bio Pharma Dive

SEPTEMBER 12, 2020

study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume. Six days after a worrisome illness in a U.K.

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Vaccine Vaccination Regulation Drugs 350

Bio Pharma Dive

OCTOBER 21, 2022

The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.

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Bio Pharma Dive

FEBRUARY 10, 2023

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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Bio Pharma Dive

OCTOBER 8, 2020

The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.

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Vaccine Vaccination 353

Pharmaceutical Technology

MARCH 24, 2025

The FDA has granted approval for the IND application of Everest Medicines tumour-associated antigen (TAA) vaccine, EVM14.

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FDA Approval Vaccine Vaccination Medicine 263

Pharmaceutical Technology

JUNE 25, 2024

1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above. Novavax has sought EMA approval for its updated JN.1

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Vaccine Vaccination 321

Bio Pharma Dive

MAY 10, 2021

The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states are beginning to report waning demand.

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Vaccine Vaccination 333

Bio Pharma Dive

APRIL 23, 2021

A vaccine co-developed by the U.K. academic center and the Maryland biotech could be the first to meet the WHO's efficacy target for a malaria vaccine.

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Vaccine Vaccination Development 330

Bio Pharma Dive

JANUARY 23, 2023

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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Vaccine Vaccination Scientist 319

Bio Pharma Dive

FEBRUARY 1, 2023

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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Vaccine Vaccination 357

Bio Pharma Dive

MAY 24, 2022

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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Vaccine Vaccination Development 344

Bio Pharma Dive

DECEMBER 11, 2020

Vaccinations are expected to begin within days of the historic decision, which follows early approvals in the U.K., Canada and Mexico.

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Vaccine Vaccination 351

Bio Pharma Dive

OCTOBER 16, 2020

Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval.

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Vaccine Vaccination 348

Bio Pharma Dive

DECEMBER 16, 2021

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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Vaccine Vaccination 330

Bio Pharma Dive

JANUARY 26, 2021

The French drugmaker, having hit delays with its own coronavirus shot, agreed to manufacture over 100 million doses of Pfizer and BioNTech's vaccine for supply in Europe.

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Vaccine Vaccination Manufacturing 355

Bio Pharma Dive

MAY 4, 2021

The sum is $11 billion higher than Pfizer had estimated in February and, if realized, would make the vaccine the highest grossing pharmaceutical product by revenue in a single year.

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Bio Pharma Dive

NOVEMBER 9, 2020

An interim analysis conducted after 94 cases of COVID-19 in Pfizer and BioNTech's large study found their vaccine to be more than 90% effective.

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Vaccine Vaccination 344

Bio Pharma Dive

JANUARY 29, 2021

The vaccine's efficacy was higher in the U.S., but lower in Latin America and South Africa, where new, more infectious virus variants are circulating.

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Vaccine Vaccination Trials 353

Bio Pharma Dive

JANUARY 29, 2021

A deal to fill vials of Pfizer and BioNTech's vaccine could be the first of several Novartis signs to help others make COVID-19 treatments.

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Vaccine Vaccination Manufacturing 327

Bio Pharma Dive

OCTOBER 12, 2022

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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Bio Pharma Dive

AUGUST 31, 2021

Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.

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Vaccine Vaccination 363

Bio Pharma Dive

SEPTEMBER 8, 2020

A participant in a clinical trial of the experimental shot suffered from an unexplained illness, triggering an investigation and a pause in vaccinations.

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Bio Pharma Dive

SEPTEMBER 8, 2021

The company has previously said it could make up to three billion vaccine doses in 2022, depending on how booster shots are authorized.

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Vaccine Vaccination 335

Pharmaceutical Technology

MAY 10, 2024

The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.

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FDA Approval Vaccine Vaccination Development 279

Bio Pharma Dive

DECEMBER 9, 2020

A panel of vaccine and infectious disease experts will publicly vet the drugmakers' study results on Thursday. Follow the discussion along with BioPharma Dive reporters here.

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Vaccine Vaccination 324

Bio Pharma Dive

AUGUST 23, 2021

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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Vaccine Vaccination 324