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The Next Generation of Vaccine Mega Trials

PPD

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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The Vaccine Development Landscape and Its Associated Challenges

DrugBank

Vaccines have consistently demonstrated their efficacy in protecting people from infectious diseases. Yet, the recent COVID-19 pandemic highlighted the obstacles that are inherent today in the development of vaccines. Stabilizers play a crucial role in maintaining the vaccine's potency and integrity throughout its shelf life.

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Keys to Success in Vaccine Development for Special Populations

PPD

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

The Pharma Data

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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Everyone Who Gets COVID-19 Vaccine Will Receive Vaccination Card

The Pharma Data

3, 2020 — All Americans who get a COVID-19 vaccine will get a vaccination card, officials say. associate director of the Immunization Action Coalition, which supports frontline workers who will administer COVID-19 vaccinations, CNN reported. Further Support and Information on COVID-19. THURSDAY, Dec. CNN Article.

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COADMINISTRATION OF ITS 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

The Pharma Data

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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Johnson & Johnson Statement on COVID-19 Vaccine (Updated)

The Pharma Data

We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine. cases out of more than 6.8

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