AstraZeneca Archives - Page 8 of 9 - Medical Design Sourcing

AstraZeneca doubles down on COVID-19 vaccine performance

After a quarrel with its independent data safety monitoring board, AstraZeneca confirmed that its COVID-19 vaccine offers strong performance in protecting against COVID-19 in a U.S. study.

The company announced that the vaccine was 76% effective against symptomatic COVID-19. That figure was three points lower than the percentage it released on Monday. The data safety monitoring board had accused the company of cherry-picking data to inflate its efficacy rating. The 76% efficacy figure of the two-shot vaccine is marginally higher than that of the one-dose Johnson & Johnson vaccine. The J&J vaccine was 72% effective in the U.S. and 66% globally.

The 76% efficacy rate for AstraZeneca’s vaccine reflects a more recent validation of the study’s statistical analysis, including COVID-19 cases reported later in the trial.

The data is 100% effective at protecting against severe disease and death, according to AstraZeneca.

The company could release c…

EU threatens to tighten COVID-19 vaccine exports

The European Union announced plans to invoke emergency rules that could substantially reduce exports to the United Kingdom and other countries for six weeks.

AstraZeneca, a central provider of vaccines to the European Union, had reduced EU projected shipments to the EU after encountering production delays at plants in Belgium and the Netherlands.

AstraZeneca will likely face the biggest impact from the rules, which would also apply to Pfizer and Moderna vaccines.

Canada and Israel also rely on EU-produced COVID-19 vaccines.

The U.S. and U.K. are largely reliant on domestically-produced vaccines.

It’s possible, however, that the EU and U.K. will come to a common agreement related to COVID-19 shipments. A joint statement released from the two governments describes an attempt to “ensure a reciprocally beneficial relationship between the UK and EU on COVID-19.”

U.K. prime minister Boris Johnson had earlier expressed frustration at the pl…

An overview of the AstraZeneca COVID-19 vaccine saga

Over the past several months, AstraZeneca has struggled to win broad support for its vaccine, which it jointly developed with Oxford University. In the past several months, a series of bruising headlines have put the company on the defensive, forcing the company to issue a series of statements answering questions over its vaccine data.

The AstraZeneca vaccine will likely be the fourth to be authorized in the U.S. There is “a growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups,” said Mene Pangalos, executive vice president, biopharmaceuticals R&D at AstraZeneca in a statement on data from its U.S. clinical trial.

Several health authorities ranging from the WHO to the U.K.-based Medicines and Healthcare products Agency have supported the vaccine’s safety and efficacy.

AstraZeneca did not immediately respond to a request for comment for this story.

No…

NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial.

NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned after information released by the company surrounding the clinical trial for its AZD1222 vaccine may be outdated. In turn, that may have provided an incomplete view of the efficacy data, NIAID said.

Get the full story at our sister site, Drug Discovery & Development.

NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial.

NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned after information released by the company surrounding the clinical trial for its AZD1222 vaccine may be outdated. In turn, that may have provided an incomplete view of the efficacy data, NIAID said.

“We urge the company to work with the [Data and Safety Monitoring Board (DSMB)] to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” NIAID wrote in the statement.

AstraZeneca yesterday published results from the trial, revealing that the vaccine developed in collaboration with Oxford University was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization.

Buoyed b…

AstraZeneca touts COVID-19 vaccine study results, will seek FDA nod

AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial.

AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity and age, with participants aged 65 and older experiencing an effectiveness of 80%.

The two-dose vaccine is administered at a four-week interval. It can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and can be administered without the need for preparation within existing healthcare settings.

Get the full story at our sister site, Drug Discovery & Development.

AstraZeneca touts COVID-19 vaccine study results, will seek FDA nod

AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial.

AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity and age, with participants aged 65 and older experiencing an effectiveness of 80%.

The two-dose vaccine is administered at a four-week interval. It can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and can be administered without the need for preparation within existing healthcare settings.

“These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in…

HRS Heat Exchangers is helping to support COVID-19 vaccine production: Here’s how

Image from HRS Heat Exchangers

HRS Heat Exchangers announced that it received orders for pharmaceutical heat exchangers for use with the manufacturing of COVID-19 vaccines.

Orders were placed by subcontractors working with Pfizer and Moderna, which both have vaccines authorized in the U.S., and Oxford/AstraZeneca, which has been approved across Europe but not yet in the U.S. The orders are set for use in the United Kingdom and in Europe and cover different areas of the vaccine manufacturing process, according to a news release.

HRS SP05 heat exchangers are slated to be used to heat purified water and water for injection (WFI) which is used as make-up water in the vaccine formulation. The heat exchanger series produced by the company has high-quality, pharmaceutical-grade manufacturing and its K Series heat exchangers offer a cleaning-in-place (CIP) solution for cleaning manufacturing equipment between…

AstraZeneca vaccine offers little protection against South Africa SARS-CoV-2 variant

The ChAdOx1 COVID-19 vaccine jointly developed between AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM.

In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based on that data, the vaccine has an efficacy of 22% in protecting against mild-to-moderate disease in South Africa more than 14 days after the second dose. Efficacy against the B.1.351 variant specifically was 10.4%.

Get the full story from our sister site, Drug Discovery & Development.

AstraZeneca vaccine offers little protection against South Africa SARS-CoV-2 variant

The ChAdOx1 COVID-19 vaccine jointly developed between AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM.

In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based on that data, the vaccine has an efficacy of 22% in protecting against mild-to-moderate disease in South Africa more than 14 days after the second dose. Efficacy against the B.1.351 variant specifically was 10.4%.

Last month, South Africa decided to pause its rollout of the vaccine based on the data points, which hadn’t then been peer-reviewed.

The B.1.351 variant has three mutations in the receptor-binding domain portion of the virus, which enhance transmissibility.

The AstraZeneca remains 75% effective against the B.1.1.7 variant, which was first identified in the U.…

WHO: AstraZeneca vaccine pauses in EU unwarranted

The World Health Organization endorsed the AstraZeneca COVID-19 vaccine after several European countries have halted its use over potential safety risks.

AstraZeneca has observed 15 deep vein thrombosis (DVT) reports and 22 pulmonary embolism (PE) cases out of 17 million vaccine recipients in the E.U. and U.K. as of March 8. Based on that data, the incidence rate among that population would be roughly 0.00022%. The company issued a statement saying the rate of events is “much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.

WHO stressed in prepared remarks that COVID-19 vaccines cannot “reduce illness or deaths from other causes” and that “thromboembolic events are known to occur frequently.”

The agency said, based on the data currently available, the benefits of the vaccine outweigh the risks.

Blood clot fears prompt Europe to suspend use of AstraZeneca vaccine

Although no causal link has been found between blood clots and the AstraZeneca COVID-19 vaccine, several European nations have decided to suspend its use out of an abundance of caution.

Germany, France, Italy, and Spain recently halted the use of the vaccine following reports of blood clots in the brains of vaccinated people.

There have been 37 blood clot reports among more than 17 million doses administered in the EU and the U.K.

The bans are likely to be temporary. The European Medicines Agency has recommended the continued use of the vaccine, stating that the vaccines outweigh the possible risks. The agency will likely offer its interpretation of the blood clot reports this week.

The World Health Organization has also stated that it, to date, has found no links between blood clots and the AstraZeneca vaccine, which was jointed developed with Oxford University.

The incidence of blood clots in AstraZeneca vaccine recipients is in line with…