Tag: AstraZeneca

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Vaccine Makers are Working to Determine how well the Current Vaccine Formulations hold up Against Omicron

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the staff of the Ridgewood blog
Ridgewood NJ, the emergence of the Omicron SARS-CoV-2 variant in southern Africa has vaccine manufacturers discussing vaccine effectiveness and the possibility of updating vaccines to make them variant-specific. Omicron has around 50 mutations, and more than 30 of the mutations are located on the viral spike protein that is responsible for entry into host cells. The SARS-CoV-2 spike protein also is one of the primary antibody targets for the immune system. According to some analysis, most of the antibody target sites on Omicron’s spike protein are mutated, and several of those differences could indicate that Omicron is capable of escaping current vaccine formulations. A subset of Omicron’s spike mutations have been previously reported in the Beta and Delta variants, but 26 spike mutations are believed to be unique. Scientists are anticipating a decrease in antibody neutralization of the virus, and doctors in South Africa are reporting reinfections in patients who have already recovered from COVID-19.

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US National Institute of Allergy and Infectious Diseases Questions AstraZeneca COVID vaccine’s Efficacy Estimate

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the staff of the Ridgewood blog
Ridgewood NJ, according to Johns Hopkins Center for Health Security, AstraZeneca announced preliminary results from a Phase 3 clinical trial for its SARS-CoV-2 vaccine, developed in collaboration with the University of Oxford. The trial included more than 32,000 participants in Chile, Peru, and the US, including 21,583 who received at least one dose of the vaccine. The press release reports an overall efficacy of 79% against any COVID-19 disease among all age groups and 80% efficacy for adults aged 65 years and older. Additionally, the press release describes 100% efficacy against severe disease and hospitalization. AstraZeneca explicitly noted that an independent review of the safety data “found no increased risk of thrombosis or events characterized by thrombosis” associated with the vaccine. Previous analysis of data from trials in Brazil, South Africa, and the UK estimated the overall efficacy to be 60%.

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AstraZeneca US Phase III trial 79% vaccine efficacy at preventing symptomatic COVID-19

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the staff of the Ridgewood blog

Ridgewood NJ, The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.

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AstraZeneca Faces Hurdles to Regulatory Approval of COVID19 Vaccine

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 the staff of the Ridgewood blog
Ridgewood NJ, previously reported on the Ridgewood blog that AstraZeneca issued a press release regarding preliminary results from the Phase 3 clinical trials of its candidate SARS-CoV-2 vaccine, developed in collaboration with Oxford University (UK). According to Johns Hopkins Center for Health Security ,the press release indicates that the vaccine demonstrated 90% efficacy when administered as an initial half-dose followed by a full dose a month later. Interestingly, however, the vaccine was 62% efficacious in participants who received 2 full doses over the same period of time, resulting in an overall efficacy of 70%. No serious adverse events were identified in the trials. In total, the Phase 3 portion of the trials included more than 11,000 participants, and the researchers identified 131 COVID-19 cases. As has been the case throughout the pandemic, the data published via press release have not yet been peer reviewed, although the researchers reportedly intend to publish the full data in the near future.

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University of Oxford-AstraZeneca Coronavirus Vaccine Produces Strong Immune Response in Older Adults

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University of Oxford , The ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults aged 56-69 and those over 70 years of age. The data, published today in The Lancet, suggest that one of the groups most vulnerable to serious illness, and death from COVID-19, could build immunity.

British pharmaceutical giant AstraZeneca, which is working in collaboration with the University of Oxford, has previously said interim data showed their experimental vaccine had produced an immune response in older and younger adults.

Older adults have been shown to be at higher risk from COVID-19 and should be considered to be a priority for immunisation should any effective vaccine be developed for the disease. Reporting on data from a Phase II trial of the ChAdOx1 nCov-2019 vaccine, the authors write that volunteers in the trial demonstrate similar neutralising antibody titres, and T cell responses across all three age groups (18-55, 56-79, and 70+).

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AstraZeneca and Johnson & Johnson, vaccine trials are positioned to restart after being paused over potential safety concerns

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the staff of the Ridgewood blog

New Brunswick NJ, according to Johns Hopkins Center for Health Security two major vaccine trials, those of AstraZeneca and Johnson & Johnson, are positioned to restart after being paused over potential safety concerns. The AstraZeneca trial was paused on September 6th, but after independent monitoring of the adverse event several trial sites in other countries resumed later in September. The US FDA held off on restarting AstraZeneca trial sites in the US through October in order to further investigate the event with their own team. The Johnson & Johnson vaccine trial was paused on October 11 after a participant suffered a stroke. This adverse event was also independently reviewed and a final report was sent to the US FDA that recommends the vaccine trial continue. The Johnson & Johnson trial can start re-enrolling participants as early as next week. This vaccine is of particular interest to many since it is a one-dose vaccine which would greatly simplify the process of quickly inoculating millions of people. The AstraZeneca vaccine has already shown promising preliminary results and seems to produce an immunogenic response in elderly participants as well as in younger ones. It is important that any eventual vaccine can produce immunogenic responses in the eldery, in children, and in those with underlying conditions. The Pfizer vaccine has begun to enroll a cohort of children between the ages of 12-18 to test its efficacy in this age group. 16- and 17-year-old volunteers are the first to be enrolled in this study, with researchers soon looking to enroll their younger peers.

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COVID19 : LATEST VACCINE CLINICAL TRIALS

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the staff of the Ridgewood Blog
Oxford UK,  according to Johns Hopkins Center for Health Security, less than a week after suspending Phase 3 clinical trials for its candidate SARS-CoV-2 vaccine due to a serious adverse event, AstraZeneca announced that the trials have resumed in the UK. According to a press release issued by AstraZeneca, the trials resumed after the UK government’s Medicines Health Regulatory Authority (MHRA) evaluated the evidence and determined that it was safe to continue testing the vaccine. The press release states that AstraZeneca and the University of Oxford are not permitted to “disclose further medical information” regarding the adverse event, presumably including the associated safety data reviewed by MHRA or the results of their analysis. It appears that the Phase 3 trials in other countries remain on hold.

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AstraZeneca’s COVID19 Vaccine Trial Paused Over Safety Concerns

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the staff of the Ridgewood blog

Oxford UK, The Phase 3 clinical trial for AstraZeneca’s candidate SARS-CoV-2 vaccine (developed in collaboration with Oxford University) has been paused following the identification of a serious adverse event in one of the participants. Neither AstraZeneca nor Oxford University have yet disclosed details of the adverse event, which reportedly occurred in the UK; however, The New York Times reports that the patient developed transverse myelitis. It has not yet been determined whether the condition was associated with the vaccine. An earlier clinical trial for the AstraZeneca vaccine was also paused following the diagnosis of transverse myelitis in a participant, but the trial resumed after a safety review determined that the condition was not related to the vaccine.

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AstraZeneca COVID-19 Vaccine Expands into US Phase III clinical trial across all adult age groups

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the staff of the Ridgewood blog

Ridgewood NJ, AstraZeneca COVID19 vaccine expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity.1

The  US trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine. Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”

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Two COVID19 Vaccines Show Promising Results

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the staff of the Ridgewood blog

Ridgewood NJ, two studies were published in The Lancet, describing results of clinical trials for candidate vaccines from China and the UK. The candidate from Chinese pharmaceutical manufacturer CanSino is a single-dose vaccine that utilizes a recombinant adenovirus vector. The associated trial was a randomized, double-blind, placebo-controlled Phase 2 trial that involved 508 healthy human volunteers in Wuhan, China. Two dosages were tested, and both demonstrated high seroconversion after 4 weeks (96% and 97%, respectively) and significant neutralizing antibody response. Severe adverse reactions were reported in 9% of those receiving the higher dose and 1% of those receiving the lower dose, a statistically significant difference. Based on these results, the researchers intend to conduct a Phase 3 trial for the lower vaccine dose in the near future.

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