XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. Related: Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

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pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . of individuals in low-income countries have received their first dose.

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pharmaphorum

DECEMBER 16, 2022

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. Vaccine access for a price. Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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XTalks

FEBRUARY 19, 2024

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

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The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine. COVID-19 Vaccine AstraZeneca , formerly AZD1222.

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Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.

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The Pharma Data

AUGUST 28, 2020

The government plans to train up an army of health professionals to be ready to give the coronavirus vaccine, if and when one is shown to work. This could include pharmacists, who already deliver flu vaccines, midwives and physiotherapists. But a vaccine is not expected to be ready before Christmas. Source link.

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The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,

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The Pharma Data

MAY 4, 2021

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has banned the trade in unapproved COVID-19 vaccines for a year to prevent the use of vaccines that may not be safe or effective. . The public could also import personal supplies of vaccines. TGA warns of unlawful advertising of listed medicines.

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The Pharma Data

JANUARY 6, 2021

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

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The Pharma Data

NOVEMBER 13, 2020

WHO today listed the nOPV2 vaccine (Bio Farma, Indonesia) for emergency use to address the rising cases of a vaccine-derived polio strain in a number of African and East Mediterranean countries. The emergency use listing, or EUL, is the first of its kind for a vaccine and paves the way for potential listing of COVID-19 vaccines.

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The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. million doses of the COVID-19 Vaccine Moderna. About the COVID-19 Vaccine Moderna.

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XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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The Pharma Data

MARCH 2, 2021

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. “For

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The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. in the U.S.)

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The Pharma Data

NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

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The Pharma Data

MARCH 26, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

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The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

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The Pharma Data

MARCH 11, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

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The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. This press release features multimedia.

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The Pharma Data

MAY 6, 2021

Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.

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The Pharma Data

FEBRUARY 24, 2022

If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older. . The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. and Europe.

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The Pharma Data

JANUARY 31, 2021

Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. This press release features multimedia. View the full release here: [link].

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The Pharma Data

OCTOBER 15, 2020

More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. The vaccine trial, which has resumed in other countries but remains halted in the U.S., The length of time the U.S.

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The Pharma Data

OCTOBER 19, 2020

.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S.

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The Pharma Data

OCTOBER 14, 2020

Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and may lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19. CHATHAM, N.J., About TNX-1800. 2018) PLoS One.

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The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

JANUARY 4, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. The MOH has secured 6 million doses of the COVID-19 Vaccine Moderna.

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