COVID-19 vaccine trial Archives - Page 9 of 13

NIH launches study of allergic reactions to COVID-19 vaccines

(Image by Sam Moqadam on Unsplash)

The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines.

Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the public began. Still, such anaphylactic reactions are rare, with only a few cases per million doses. To put things in perspective, tens of thousands of Americans end up in emergency rooms annually with severe allergic reactions.

The NIH’s National Institute of Allergy and Infectious Diseases is sponsoring and funding the news study, which is enrolling 3,400 adults ages 18 to 69 years at up to 35 academic allergy-research centers nationwide.

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

AstraZeneca vaccine linked to rare blood clots, according to EMA official

European Medicines Agency (EMA) official Marco Cavaleri said there was a link between AstraZeneca’s COVID-19 vaccine and rare reports of blood clots, including pulmonary embolism, deep vein thrombosis and thrombocytopenia, according to a Reuters report.

Two separate research groups in Europe had reached similar conclusions regarding the blood clots in March.

AstraZeneca had previously downplayed the possibility that its COVID-19 vaccine is linked to such events. The company did not immediately respond to a request for a comment.

The benefits of the vaccine, which was jointly developed by AstraZeneca and Oxford University, still outweigh the risks, said Marco Cavaleri, head of health threats and vaccine strategy, in an interview with Rome’s Il Messaggero paper.

EMA is poised to make a formal announcement regarding the subject, Cavaleri said.

The EMA press office itself notes that it “has not yet reached a conclusion, and the review is curren…

Johnson & Johnson to test COVID-19 vaccine in adolescents

Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in a study involving 12-to-15 year-olds. FDA has already authorized its vaccine for patients 16 or older.

Moderna (NSDQ:MRNA) announced plans to launch a Phase 2/3 study known as TeenCove that will test its COVID-19 vaccine in adolescents aged 12 to 18.

Johnson & Johnson’s recent announcement shared its plans to extend its randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to adolescents.

The study had previously intended to evaluate the reactogenicity and immunogenicity of its Ad26.COV2.S vaccine after administering it in a vari…

Moderna begins study on variant-specific COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) is beginning a new Phase 1 study to test the effectiveness of a new version of its COVID-19 vaccine designed to enhance protection against the B.1.351 first detected in South Africa.

The recent study will help Moderna and its partner, the National Institute of Allergy and Infectious Diseases determine whether to update the vaccine.

Moderna had announced its plans to launch the study in January.

In February, the company announced that it had completed manufacturing of a variant-specific vaccine candidate, known as 1273.351. Moderna anticipates that the clinical trial will be fully enrolled by the end of April.

The B.1.351 variant has similar mutations to other variants of concern spotted in the U.K. and Brazil.

The study will enroll approximately 210 healthy adults in four centers across the U.S.

Modern…

Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months

The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine

The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 COVID-19 vaccine was effective for at least 90 days after the second dose.

Pfizer plans on releasing more data related to the long-term vaccine immunogenicity in the coming weeks.

Pfizer and BioNTech plan on doing two years of follow-up for their Phase 3 vaccine trial.

Earlier this year, the two companies released data indicating that their vaccine also remains effective against a highly-transmissible SARS-CoV-2 variant first identified in South Africa.

Pfizer and BioNTech are also testing the vaccine on adolescents. Recent data suggest that the vaccine is 100% effective in ad…

Pfizer and Moderna COVID-19 vaccines 90% effective in real-world study

[Photo by Daniel Schludi on Unsplash]

A single dose of Pfizer or Moderna vaccine is about 80% effective at preventing COVID-19 infection at least two weeks after injection. The efficacy level rises to 90% two weeks after the second dose of either mRNA vaccine, according to a recent CDC study involving roughly 4,000 essential workers.

In contrast to the Phase 3 trials from Pfizer-BioNTech and Moderna, the CDC study analyzed vaccines’ ability to prevent COVID-19 infection. Study participants underwent weekly COVID-19 testing for 13 consecutive weeks.

Conversely, the Pfizer-BioNTech and Moderna Phase 3 trials sought to analyze their vaccines’ ability to prevent symptomatic COVID-19 disease. Participants in the Pfizer had to have at least one COVID-19 symptom before they received a SARS-CoV-2 test. Study volunteers in the Moderna trial had to have at least two systemic symptoms or one respiratory symptom …

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…

Oravax to focus on oral COVID-19 vaccine

Premas Biotech (Gurugram, India) and Oramed Pharmaceuticals (Jerusalem) have announced that they are developing an oral COVID-19 vaccine that has shown efficacy after a single dose in animals.

To accelerate the development of the vaccine, the two companies have created a joint venture known as Oravax Medical.

The availability of effective single-dose oral COVID-19 vaccines could go far in simplifying logistics.

Supply chain challenges have hampered mass vaccination campaigns in many parts of the world. Many coronavirus vaccines require two doses and several require uncommonly cold storage temperatures.

“An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale distribution, enabling people to take the vaccine themselves at home,” said Nadav Kidron, CEO of Oramed in a statement. “While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the likely case tha…

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.…