Tag Archives: vaccine
Moderna Inc said it had dosed the first participant in an early-stage study of a new COVID-19 vaccine candidate that could potentially be stored and shipped in refrigerators instead of freezers. The company said its new candidate could make it easier for distribution, especially in developing countries where supply chain issues could hamper vaccination drives.
The early-stage study will assess the safety and immunogenicity of the next-generation vaccine, designated as mRNA-1283, at three dose levels, and will be given to healthy adults either as a single dose or in two doses 28 days apart, the company said. Moderna also plans to evaluate the new vaccine, mRNA-1283, as a potential booster shot in future studies.
Last week, Moderna began dosing the first participants in a study testing COVID-19 booster vaccine candidates targeting the variant, known as B.1.351, that first emerged in South Africa.
The booster vaccine candidates, designated mRNA-1273.351, will be tested in a trial of both a variant-specific shot and a multivalent shot, according to the company’s announcement.
Researchers from Cleveland Clinic’s Global Center for Pathogen Research & Human Health have developed a promising new COVID-19 vaccine candidate that utilizes nanotechnology and has shown strong efficacy in preclinical disease models.
According to new findings published in mBio, the vaccine produced potent neutralizing antibodies among preclinical models and also prevented infection and disease symptoms in the face of exposure to SARS-CoV-2 (the virus that causes COVID-19). An additional reason for the vaccine candidate’s early appeal is that it may be thermostable, which would make it easier to transport and store than currently authorized COVID-19 vaccines.
“Our vaccine candidate delivers antigens to trigger an immune response via nanoparticles engineered from ferritin–a protein found in almost all living organisms,” said Jae Jung, PhD, director of the Global Center for Human Health & Pathogen Research and co-senior author on the study. “This protein is an attractive biomaterial for vaccine and drug delivery for many reasons, including that it does not require strict temperature control.”
Added Dokyun (Leo) Kim, a graduate student in Dr. Jung’s lab and co-first author on the study, “This would dramatically ease shipping and storage constraints, which are challenges we’re currently experiencing in national distribution efforts. It would also be beneficial for distribution to developing countries.”
Other benefits of the protein nanoparticles include minimizing cellular damage and providing stronger immunity at lower doses than traditional protein subunit vaccines against other viruses, like influenza.
The team’s vaccine uses the ferritin nanoparticles to deliver tiny, weakened fragments from the region of the SARS-CoV-2 spike protein that selectively binds to the human entry point for the virus (this fragment is called the receptor-binding domain, or RBD). When the SARS-CoV-2 RBD binds with the human protein called ACE2 (angiotensin-converting enzyme 2), the virus can enter host cells and begin to replicate.
The researchers tested their vaccine candidate on a ferret model of COVID-19, which reflects the human immune response and disease development better than other preclinical models. Dr. Jung, a foremost authority in virology and virus-induced cancers, previously developed the world’s first COVID-19 ferret model–a discovery that has significantly advanced research into SARS-CoV-2 infection and transmission.
A coronavirus variant called B1525 has become one of the most recent additions to the global variant watch list and has been included in the list of variants under investigation by Public Health England.
Scientists are keeping a watchful eye on this variant because it has several mutations in the gene that makes the spike protein – the part of the virus that latches onto human cells. These changes include the presence of the increasingly well-known mutation called E484K, which allows the virus to partly evade the immune system, and is found in the variants first identified in South Africa (B1351) and Brazil (P1).
While there is no information on what this means for B1525, there is growing evidence that E484K may impact how effective COVID vaccines are. But there is no suggestion so far that B1525 is more transmissible or that it leads to more severe disease.
There are other mutations in B1525 that are also noteworthy, such as Q677H. Scientists have repeatedly detected this change – at least six times in different lineages in the US, suggesting that it gives the virus an advantage, although the nature of any benefit has not been identified yet.
The B1525 variant also has several deletions – where “letters” (G, U, A and C) of the virus’s RNA are missing from its genome. These letters are also missing in B117, the variant first detected in Kent, England. Research by Ravindra Gupta, a clinical microbiologist at the University of Cambridge, found that these deletions may increase infectivity twofold in laboratory experiments.
As with many variants, B1525 appears to have emerged quite recently. The earliest example in the shared global database of coronavirus genomes, called Gisaid, dates from 15 December 2020. It was identified in a person in the UK. And like many variants, B1525 had already travelled the world before it came to global attention. A total of 204 sequences of this variant in Gisaid can be traced to 18 countries as of 20 February 2021.
COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death
The primary analysis of the Phase III clinical trials from the UK, Brazil and South Africa, published as a preprint in The Lancet confirmed COVID-19 Vaccine AstraZeneca is safe and effective at preventing COVID-19, with no severe cases and no hospitalisations, more than 22 days after the first dose.
Results demonstrated vaccine efficacy of 76% (CI: 59% to 86%) after a first dose, with protection maintained to the second dose. With an inter-dose interval of 12 weeks or more, vaccine efficacy increased to 82% (CI: 63%, 92%).
The analysis also showed the potential for the vaccine to reduce asymptomatic transmission of the virus, based on weekly swabs obtained from volunteers in the UK trial. The data showed that PCR positive readings were reduced by 67% (CI: 49%, 78%) after a single dose, and 50% (CI: 38% to 59%) after the two dose regimen, supporting a substantial impact on transmission of the virus.
The primary analysis for efficacy was based on 17,177 participants accruing 332 symptomatic cases from the Phase III UK (COV002), Brazil (COV003) and South Africa (COV005) trials led by Oxford University and AstraZeneca, a further 201 cases than previously reported.
“This primary analysis reconfirms that our vaccine prevents severe disease and keeps people out of hospital. In addition, extending the dosing interval not only boosts the vaccine’s efficacy, but also enables more people to be vaccinated upfront. Together with the new findings on reduced transmission, we believe this vaccine will have a real impact on the pandemic,”said Sir Mene Pangalos, Executive Vice President BioPharmaceuticals R&D.
“These new data provide an important verification of the interim data that has helped regulators such as the MHRA in the UK and elsewhere around the world to grant the vaccine emergency use authorisation. It also helps to support the policy recommendation made by the Joint Committee on Vaccination and Immunisation for a 12-week prime-boost interval, as they look for the optimal approach to roll out, and reassures us that people are protected 22 days after a single dose of the vaccine,” explained Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial, and co-author of the paper.
Data will continue to be analysed and shared with regulators around the world to support their ongoing rolling reviews for emergency supply or conditional approval during the health crisis. AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.
The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
The Johnson & Johnson vaccine is getting a lot of people excited. Not only is it another potential option to protect more people from COVID-19, but their vaccine is only one dose, making it a lot easier to reach a broad swath of the population.
In Orange County, the fourth-highest county in the state for vaccine distribution, more than 82,000 initial doses have gone out. Across the sunshine state, more than 1.6 million Floridians have received at least their first dose with nearly 300,000 having completed their vaccine series. Nationwide, the U.S. is inching closer toward 30 million Americans having received at least one dose of the vaccine to protect them against COVID-19.
Johnson & Johnson’s vaccine isn’t approved just yet but it is expected to become the third vaccine for roll out across the country. With just a single dose needed, health leaders say this could be a game changer. Johnson & Johnson’s vaccine is only 66 percent effective compared to the 90 plus efficacy rate of both Pfizer and Moderna’s vaccine. However, health leaders stress that data is still promising. And Johnson & Johnson’s doses can remain stable for two years at -4 degree temperatures or at least three months when stored at 36 to 46 degree (8 degree Celsius) temperatures.
Johnson & Johnson say they have product ready to ship out immediately pending approvals. They’re expected to file for emergency use authorization for their vaccine early February.
Israel‘s Health Minister Edelstein provided ministry data showing that 2,272,000 people have so far had the first of the two-shot Pfizer-BioNTech vaccine, including 550,000 who have also had their second dose. The number represents close to a quarter of Israel’s 9.3 million citizens and maintains its position as the country with the highest per capita vaccination rate in the world, according to monitoring groups.
Edelstein on Wednesday presented figures showing that over 210,000 vaccination shots were administered the day before, a new record for the country’s mass inoculation program.
Israelis recieve a Covid-19 vaccine, at a vaccination center operated by the Tel Aviv Municipality
Urging continued adherence to Health Ministry lockdown guidelines, which on Tuesday were extended until January 31, Edelstein wrote “a little more and this will be behind us.”
His figures were more optimistic than numbers released by the ministry during the morning, which showed that 56,008 people had their first dose on Tuesday and another 114,769 had the second shot for a total of 170,777. It was not clear why there was a discrepancy in the numbers.
The ministry said 8,511 new cases were confirmed Tuesday, a drop of some 1,500 from the record-shattering 10,058 cases detected on Monday. The figure for Tuesday was the lowest weekday daily caseload in over a week. The positive test rate also dropped to 9.2%, having reached 10.2% on Monday.
Norway expressed increasing concern about the safety of the Pfizer Inc. vaccine on elderly people with serious underlying health conditions after raising an estimate of the number who died after receiving inoculations to 29. The latest figure adds six to the number of known fatalities in Norway, and lowers the age group thought to be affected to 75 from 80. While it’s unclear exactly when the deaths occurred, Norway has given at least one dose to about 42,000 people and focused on those considered most at risk if they contract the virus, including the elderly.
“There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said. All the reported deaths related to “elderly people with serious basic disorders,” it said. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition.”
Official reports of allergic reactions have been rare as governments rush to roll out vaccines to try to contain the global pandemic. U.S. authorities reported 21 cases of severe allergic reactions from Dec. 14-23 after administration of about 1.9 million initial doses of the Pfizer vaccine. The first Europe-wide safety report on the Pfizer-BioNTech vaccine is due to be published at the end of January. Until Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.
The Astrazenezca/Oxford vaccine could be rolled out across the UK within the next fortnight as the head of the company raised hopes of the jab’s “winning formula”. The Government is aiming for mass vaccination centres to start administering patients with either the AstraZeneca/Oxford or Pfizer jab from January 4, according to told the Sunday Telegraph, as the new variant of coronavirus first found in the UK continues to spread across the world. The Medicines and Healthcare products Regulatory Agency (MHRA) could reportedly approve the homegrown jab within days, with millions poised to start receiving the jab at the start of next month.
It comes as the AstraZeneca chief said he believed researchers had found the “winning formula” using two doses and promised to publish the results.
“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” Pascal Soriot told The Sunday Times. “I can’t tell you more because we will publish at some point.”
Health Secretary Matt Hancock said at least 60 different local authorities had recorded Covid infections caused by the new variant. He said the World Health Organization had been notified and UK scientists were doing detailed studies.“Nothing to suggest” it caused worse disease or that vaccines would no longer work, he added. Over the last week, there had been sharp, exponential rises in coronavirus infections across London, Kent, parts of Essex and Hertfordshire.
“We’ve currently identified over 1,000 cases with this variant predominantly in the South of England although cases have been identified in nearly 60 different local authority areas.“We do not know the extent to which this is because of the new variant but no matter its cause we have to take swift and decisive action which unfortunately is absolutely essential to control this deadly disease while the vaccine is rolled out”, he explained.
England’s Chief Medical Officer Prof Chris Whitty said current coronavirus swab tests would detect the new variant that has been found predominantly in Kent and neighbouring areas in recent weeks. The changes or mutations involve the spike protein of the virus – the part that helps it infect cells, and the target Covid vaccines are designed around.
It is too soon to know exactly what this will do to the behaviour of the virus.
For epidemiologists, the COVID-19 pandemic has greatly intensified their long-standing nightmare about another virus: the emergence of a new and deadly strain of flu. A universal flu vaccine, effective against any strain of the influenza virus that can infect humans, could protect us from this peril, but progress has been slow. A novel concept for one universal vaccine candidate has now passed its first test in a small clinical trial, its developers report today in Nature Medicine.
Seasonal flu vaccines induce antibodies against the “head” (slate) of the influenza surface protein hemagglutinin, but a new universal vaccine triggers antibodies (fragments of them shown in gray) that bind to the stalk (light blue) portion
“This is an important paper,” says Aubree Gordon, an epidemiologist at the University of Michigan School of Public Health who studies influenza transmission and vaccines.
The influenza virus rapidly accumulates mutations and easily “reassorts,” or swaps, genes between strains, creating variants that can dodge any past immunity people had acquired naturally or from vaccines. That’s why a new flu vaccine must be developed each year. Existing flu vaccines contain weakened or inactivated influenza viruses with a mix of hemagglutinins (HAs), the proteins that stud their surfaces. These vaccines primarily aim to trigger antibody responses against HA’s top part, or head. Genetic changes in flu viruses rarely alter most of the head. But a small part of the head does reassort, or mutate, frequently, which allows new viral strains to dodge any immune memory and forces flu vaccinemakers to prepare new formulations each year, with updated HAs.
In the trial, 51 participants received the various vaccines and their antibodies were compared with those of 15 people who received placebos. A single shot of vaccine with chimeric HA inactivated viruses, the researchers report, “induced remarkably high antistalk antibody titers.”