DrugBaron

JANUARY 2, 2021

Over the past week a furious debate has broken out over the merits of delaying the second dose of the approved COVID vaccines, to increase the number of people who can be given a single dose. The case against doing so is clear: the labels of the approved vaccines are unambiguous that two doses should be given within a certain time window.

Vaccine 100

Vaccine Science Trials Clinical Trials 100

Science Daily: Pharmacology News

MAY 23, 2023

Researchers have engineered bacteria to synthesize an amino acid that contains a rare functional group that others have shown to have implications in the regulation of our immune system. These findings provide a foundation for developing unique vaccines and immunotherapies in the future.

Engineering 133

Engineering Vaccine Regulations Research 133

The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. The Cambridge, Mass.-based

Vaccine 52

Vaccine International Regulations Trials 52

The Pharma Data

DECEMBER 9, 2020

COVID-19 Vaccine Caution Issued by U.K. 9, 2020 — People with a “significant history” of allergic reactions should not receive the new Pfizer-BioNTech COVID-19 vaccine, U.K. regulators said Tuesday. mass vaccination program, the Associated Press reported. Professional. WEDNESDAY, Dec.

Vaccine 52

Vaccine Clinical Trials Regulations Trials 52

The Pharma Data

MARCH 18, 2021

Today the Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks. Furthermore, there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.

Vaccine 52

Vaccine Virus Regulations Production 52

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

DECEMBER 30, 2020

Is First Country to Approve Oxford-AstraZeneca COVID-19 Vaccine. 30, 2020 — Britain became the first country to give authorization to the COVID-19 vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. WEDNESDAY, Dec. The New York Times Article. © 2020 HealthDay. All rights reserved.

Vaccine 52

Vaccine Clinical Trials Government Regulations 52

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

The Pharma Data

DECEMBER 16, 2020

Moderna has revealed that it was impacted by last week’s cyberattack on the European Medicines Agency (EMA), during which hackers compromised agency computer systems and accessed vaccine regulatory submission documents for Pfizer/BioNTech’s and Moderna’s COVID-19 vaccines. biotech firms ( DID , July 22 ).

Vaccine 52

Vaccine Regulations Government Research 52

The Pharma Data

MAY 7, 2021

Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ). Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ). The US opened pandora’s box on IP waivers for Covid-19 vaccines. . In Focus: US. What happens now?

Vaccine 52

Vaccine Compounding Pharmacies Regulations Drugs 52

The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

Vaccine 52

Vaccine Trials Long-Term Care Facilities FDA 52

The Pharma Data

SEPTEMBER 23, 2020

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Eventually, it’s the public who will either take this vaccine or not, so it is to their advantage to be transparent as possible.”. Matt Fellows. Source link.

Vaccine 52

Vaccine Trials Science Regulations 52

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.

Vaccine 52

Vaccine Virus Licensing Licensing 52

The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. There were no serious adverse safety events.

Vaccine 52

Vaccine Virus Trials Regulations 52

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.

Vaccine 52

Vaccine Immune Response Nurses Government 52

The Pharma Data

SEPTEMBER 14, 2020

After sparking a wave of concern through industry and mainstream media with the news it had halted international studies investigating its COVID-19 vaccine on 6 September, AstraZeneca has now announced that clinical trial operations conducted alongside its partners at the University of Oxford are now back in full swing. Matt Fellows.

Vaccine 52

Vaccine Trials Clinical Trials International 52

The Pharma Data

JANUARY 13, 2021

Brazil’s Butantan Institute has reported that Sinovac’s COVID-19 vaccine, CoronaVac, demonstrated an overall efficacy of only 50.38 The researchers previously said that the vaccine offered 78 percent efficacy against mild-to-severe infections, but they failed to include data from volunteers who contracted mild cases.

Vaccine 52

Vaccine Trials Regulations Research 52

The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. This is the first authorisation for this vaccine.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

thought leadership

SEPTEMBER 23, 2024

Whether it’s pharmaceuticals, vaccines, or other veterinary products, companies must navigate complex regulations to bring their products to market and keep them there.

Compliance 74

Compliance Vaccine Production Regulations 74

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

DECEMBER 11, 2020

11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. regulators. A recent COVID-19 infection could put a person a bit farther back in line for the vaccine, however.

Vaccine 52

Vaccine Immune Response Virus Trials 52

The Pharma Data

APRIL 29, 2022

Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

Vaccine 52

Vaccine FDA Production Regulations 52

The Pharma Data

JANUARY 21, 2021

Because the new COVID-19 vaccines should still work on these viral interlopers. Luckily, the new variants still rely on the coronavirus’ “spike protein” to infect cells, and the two COVID vaccines now on the U.S. FRIDAY, Jan. “The spike is really critical. “I am extremely worried about the U.K.

Vaccine 52

Vaccine Virus Immune Response Disease 52

The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. We are deeply committed to providing global access to our SARS-CoV-2 vaccine candidate.

Government 52

Government Vaccine Pharmaceutical Companies Clinical Trials 52

The Pharma Data

DECEMBER 30, 2020

The United Kingdom authorized AstraZeneca ’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said. Those concerns have pushed back expected Emergency Use Authorization (EUA) of the AstraZeneca vaccine by two months.

Vaccine 52

Vaccine Trials FDA Regulations 52

The Pharma Data

MAY 5, 2022

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.

Vaccine 52

Vaccine FDA Pharmaceutical Companies Production 52

The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. November 20, 2020 — The U.S.

Vaccine 52

Vaccine FDA FDA Approval Production 52

The Pharma Data

MARCH 21, 2022

Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” said Peter Marks, M.D.,

Vaccine 52

Vaccine FDA Virus Production 52

Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

Vaccine 126

Vaccine Trials Disease Treatment 126

The Pharma Data

SEPTEMBER 22, 2020

Clinical trials testing Russia’s Sputnik-V coronavirus vaccine in India could begin in the next few weeks, according to Indian pharma firm Dr Reddy’s Laboratories Ltd. . The RDIF have said that vaccine deliveries could begin in late 2020, but Sapra feels it could take longer as the clinical trial process will take months. .

Clinical Trials 52

Clinical Trials Vaccine Trials Laboratories 52

Cytel

OCTOBER 23, 2023

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the two main divisions of the FDA responsible for regulating drugs and biological products, as well as combinations of drugs and biological products.

Packaging 69

Packaging Vaccine Regulations Production 69

The Pharma Data

SEPTEMBER 28, 2021

Many parents have questions on COVID-19 and when vaccines are going to be available for youngsters younger than 12 years aged. We are therefore also wanting to see COVID-19 vaccines available for young children. We also know that we all share the interest in ensuring this process is completed with safety at top of mind.

Vaccine 52

Vaccine FDA Science Clinical Trials 52

The Pharma Data

SEPTEMBER 12, 2020

Trials of a Covid-19 vaccine being developed by AstraZeneca and Oxford University will resume after being paused due to a reported side effect in a patient in the UK. On Tuesday, AstraZeneca said the studies were being paused while it investigated whether the adverse reaction was linked with the vaccine. Image copyright.

Vaccine 52

Vaccine Trials Virus Government 52

The Pharma Data

MARCH 24, 2021

New findings from a multi-country survey show that 50 per cent of parents whose child had a scheduled meningococcal disease (meningitis) vaccination appointment, had the appointment delayed or cancelled during the COVID-19 pandemic. pandemic’s impact on meningitis vaccinations over the last 12 months. the current need?to

Vaccine 52

Vaccine Disease Regulations Treatment 52

The Pharma Data

MARCH 29, 2022

Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

Vaccine 52

Vaccine FDA FDA Approval Immune Response 52

The Pharma Data

NOVEMBER 29, 2020

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. The FDA’s vaccines advisory committee will meet on Dec. James Miessler.

Vaccine 52

Vaccine Trials FDA Clinical Trials 52