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Coronavirus vaccine news

Yep I have seen people faint, but as Mo points out it is almost immediately.... The ones I know about anyway.
I'd say unfortunate for all those involved. Couldn't ask for worse optics. She was fine not long after and said something along the lines of "pain tolerance".
 
"Nothing to see here.

Move on and get yer vaccination. " ( copper takes out truncheon as walks towards person thumb surfing "vaccination" on mobile phone ).


I still reckon democracy and a free press are more dangerous to the West than any vaccination.

gg
 
"Nothing to see here.

Move on and get yer vaccination. " ( copper takes out truncheon as walks towards person thumb surfing "vaccination" on mobile phone ).


I still reckon democracy and a free press are more dangerous to the West than any vaccination.

gg

Democracy is the worst form of government, apart from all the others.
 
Anyone have data on the Chinese vaccine?


Haven't seen anything (DB008?) but Indonesian are going to use it expect to ignore Indo government data and look for inside information to get a sense of its efficacy.
 
I think there are 5 Coronavirus vaccines in development in China.

I haven't really been up to date with what is going on with China to be honest.


Sinovac is developing Coronavac
CoronaVac is an inactivated vaccine. It has recently been shipped to Indonesia. It’s manufactured by growing the COVID virus in laboratories and treating it with a chemical that inactivates it. The chemical locks the virus in a state where it’s unable to replicate, but its structure is maintained, allowing the body to recognise it as foreign and mount an immune response.
It’s also delivered with an adjuvant, an immune stimulant that’s given to improve the protective response. The phase 3 trials have recruited tens of thousands of participants to test vaccine efficacy and safety, and are taking place in Brazil, Indonesia and Turkey.


Sinopharm is developing 2 vaccines (the United Arab Emirates, a site of ongoing phase 3 trials, granted emergency use for one of Sinopharm’s vaccines in September, following testing in 31,000 participants).


Cansino - using a adenovirus to deliver a coronavirus protein. Phase 3 clinical trials, which began in August, are ongoing in countries including Saudi Arabia.


Anhui Zhifei Longcom has developed a protein subunit COVID-19 vaccine. Subunit vaccines use a purified piece of the virus, a protein, to trigger an immune response. It has recently started phase 3 clinical trials. There hasn’t yet been any announcement or published report of the results of phase 1 and 2 trials.


https://theconversation.com/chinas-...ork-and-where-are-they-up-to-in-trials-151589




CoronaVac


Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial


Summary - November 17, 2020.


Background


With the unprecedented morbidity and mortality associated with the COVID-19 pandemic, a vaccine against COVID-19 is urgently needed. We investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability and immunogenicity.​


Methods

In this randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, healthy adults aged 18–59 years were recruited from the community in Suining County of Jiangsu province, China. Adults with SARS-CoV-2 exposure or infection history, with axillary temperature above 37·0°C, or an allergic reaction to any vaccine component were excluded. The experimental vaccine for the phase 1 trial was manufactured using a cell factory process (CellSTACK Cell Culture Chamber 10, Corning, Wujiang, China), whereas those for the phase 2 trial were produced through a bioreactor process (ReadyToProcess WAVE 25, GE, Umea, Sweden). The phase 1 trial was done in a dose-escalating manner. At screening, participants were initially separated (1:1), with no specific randomisation, into two vaccination schedule cohorts, the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and within each cohort the first 36 participants were assigned to block 1 (low dose CoronaVac [3 μg per 0·5 mL of aluminium hydroxide diluent per dose) then another 36 were assigned to block 2 (high-dose Coronavc [6 μg per 0·5 mL of aluminium hydroxide diluent per dse]). Within each block, participants were randomly assigned (2:1), using block randomisation with a block size of six, to either two doses of CoronaVac or two doses of placebo. In the phase 2 trial, at screening, participants were initially separated (1:1), with no specific randomisation, into the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and participants were randomly assigned (2:2:1), using block randomisation with a block size of five, to receive two doses of either low-dose CoronaVac, high-dose CoronaVac, or placebo. Participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after injection in all participants who were given at least one dose of study drug (safety population). The primary immunogenic outcome was seroconversion rates of neutralising antibodies to live SARS-CoV-2 at day 14 after the last dose in the days 0 and 14 cohort, and at day 28 after the last dose in the days 0 and 28 cohort in participants who completed their allocated two-dose vaccination schedule (per-protocol population). This trial is registered with ClinicalTrials.gov, NCT04352608, and is closed to accrual.​

Findings

Between April 16 and April 25, 2020, 144 participants were enrolled in the phase 1 trial, and between May 3 and May 5, 2020, 600 participants were enrolled in the phase 2 trial. 743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population). In the phase 1 trial, the incidence of adverse reactions for the days 0 and 14 cohort was seven (29%) of 24 participants in the 3 ug group, nine (38%) of 24 in the 6 μg group, and two (8%) of 24 in the placebo group, and for the days 0 and 28 cohort was three (13%) of 24 in the 3 μg group, four (17%) of 24 in the 6 μg group, and three (13%) of 23 in the placebo group. The seroconversion of neutralising antibodies on day 14 after the days 0 and 14 vaccination schedule was seen in 11 (46%) of 24 participants in the 3 μg group, 12 (50%) of 24 in the 6 μg group, and none (0%) of 24 in the placebo group; whereas at day 28 after the days 0 and 28 vaccination schedule, seroconversion was seen in 20 (83%) of 24 in the 3 μg group, 19 (79%) of 24 in the 6 μg group, and one (4%) of 24 in the placebo group. In the phase 2 trial, the incidence of adverse reactions for the days 0 and 14 cohort was 40 (33%) of 120 participants in the 3 μg group, 42 (35%) of 120 in the 6 μg group, and 13 (22%) of 60 in the placebo group, and for the days 0 and 28 cohort was 23 (19%) of 120 in the 3 μg group, 23 (19%) of 120 in the 6 μg group, and 11 (18%) of 60 for the placebo group. Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group, and none (0%) of 59 in the placebo group.​


Interpretation

Taking safety, immunogenicity, and production capacity into account, the 3 μg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials.​


Funding

Chinese National Key Research and Development Program and Beijing Science and Technology Program.​


 
Yeah, sounds like there have been a few people with side effects. But on the scale of things, it's probably less than 0.1% ?
 
USA Statistics

I can't copy and paste the data from Bloomberg - please visit the site - very interactive.

Great vaccine tracker towards the bottom of the page too


More Than 4.2 Million Shots

Given: Covid-19 Vaccine Tracker

The U.S. has administered 1.94 million doses, according to the CDC

The biggest vaccination campaign in history has begun. More than 4.2 million doses in seven countries have been administered, according to data collected by Bloomberg. Delivering billions more will be one of the greatest logistical challenges ever undertaken.​
Vaccinations in the U.S. began Dec. 14 with health-care workers, and so far 1.94 million doses have been administered, according to a nationwide tally from the Centers for Disease Control and Prevention. Bloomberg is also tracking doses at the state and territory level to give a picture of how the rollout is going nationwide..​

 
Great read



Oxford-AstraZeneca vaccine: Bogus reports, accidental finds - the story of the jab


In the early hours of Saturday 11 January, Prof Teresa Lambe was woken up by the ping of her email. The information she had been waiting for had just arrived in her inbox: the genetic code for a new coronavirus, shared worldwide by scientists in China.​
She got to work straight away, still in her pyjamas, and was glued to her laptop for the next 48 hours. "My family didn't see me very much that weekend, but I think that set the tone for the rest of the year," she says.​
By Monday morning, she had it: the template for a new experimental coronavirus vaccine. The first death from the new virus was reported around the same time, but it was still a month before the disease it causes was named Covid-19.​
Lambe's team at Oxford University's Jenner Institute, led by Prof Sarah Gilbert, was always on the lookout for Disease X - the name given to the unknown infectious agent that could trigger the next pandemic. They had already used their experimental vaccine system against malaria and flu and, crucially, against another type of coronavirus, Middle Eastern Respiratory Syndrome (Mers). So they were confident it could work again.​

The checks did not fail, and after seven weeks they had enough doses of the vaccine to start the first trial. By this stage 10,000 volunteers had been recruited - all of them signing up within a matter of hours. Elisa Granato, a microbiologist, and Edward O'Neill, a cancer researcher, were the first two to receive Oxford's trial jab in April.

For Lambe, the vaccination of the first individuals was a monumental step. "I remember walking home from the lab and almost breaking down because we had a vaccine and got it into somebody's arm," she says.

The team waited 48 hours to check Granato and O'Neill had had no serious adverse reactions. With both doing well, they immunised a further six volunteers, and then gradually ramped up the numbers.

But only a few days later there were shocking reports on social media that the first volunteer, Granato, had died.

It wasn't true. I spoke to her that day, and she told me she had never felt better. I posted a bit of the interview online. It helped quash the story, but not completely. Bizarrely, there were suggestions the interview might be fake and she really needed to hold up that day's newspaper to the camera as "proof of life".

"It was very upsetting," says Gilbert. "A lot of work had to be done, for her sake as well as for the trial's sake, to make it clear that this was just fake news."

Disinformation spreads fast and has the potential to undo months of hard work. Green found it very stressful. "Oh God it's awful! To think how malicious that can be, how people are really spreading nasty things… that doesn't feel fair because my team were all doing their best," she says.

As the trial grew, it was clear that Oxford's small manufacturing facility would not be able to keep up with demand. The team decided to outsource some of the manufacturing to Italy. But when the first batch was ready, there was a snag - the Europe-wide lockdown meant there were no flights to airlift it from Rome.

"Eventually we chartered a plane to bring 500 doses of vaccine because it was the only way we could get it here in time," says Green.
This is a really important part of the story which ended up being highly significant months later.

The Italian manufacturers used a different technique to Oxford to check the concentration of the vaccine - effectively how many viral particles are floating in each dose. When the Oxford scientists used their method, it appeared that the Italian vaccine was double strength. What to do?

Calls were made to the medical regulators. It was agreed that volunteers should be given a half measure of the vaccine, on the basis that it was likely to equate to something more like a regular dose. This was partly a safety issue - they preferred to give them too little rather than too much.

But after a week, the scientists became aware that something unusual was going on. The volunteers were getting none of the usual side-effects - such as sore arms or fever. About 1,300 volunteers had only received a half-dose of the vaccine, rather than a full one. The independent regulators said the trial should continue and that the half-dose group could remain in the study.

The Oxford team bristle at any suggestion that there was a mistake, error, call it what you will. Perhaps the most accurate characterisation is that the volunteers were inadvertently given a lower dose. In months to come, they would be the stellar group in terms of vaccine efficacy.

From the start, the team at Oxford had had the goal of creating a vaccine that could help the world. To do that they would need billions of doses - something only industry could provide.

In November, two other vaccine trials published their results. They were astonishing. First Pfizer-BioNTech, then a week later Moderna, announced its vaccines were about 95% effective. The team in Oxford were encouraged.

Until then there was uncertainty that any vaccine could work on Covid-19, says Lambe. "There are so many infectious diseases out there that we can't impact."

Finally, on 21 November, the independent data safety committee was ready to reveal the Oxford-AstraZeneca findings. But the results were surprising - and more complex than expected.

Whereas Pfizer and Moderna had one efficacy figure from one big trial each, the Oxford jab ended up with three numbers: 70% overall, with the two full doses giving 62% protection while the smaller group, who were given that initial half dose had the highest protection, had 90%. It was a result no-one had expected.

Crucially, no-one who got the vaccine was hospitalised or got seriously ill due to Covid. Whereas in the control group there were 10 serious cases and one death.

The fact that those who had unwittingly been given the initial half dose from Italy showed stronger protection is intriguing. It may be caused by the immune system being primed more gradually, but the scientists can't yet explain it. Also, all the volunteers in this group were under 55.


 
Geezzass smaller dose given not because of a scientific strategy but because of circumstances forced on them.

Oh well how ever we get there o_O

Great to see the safety record held up.
 
The fact that those who had unwittingly been given the initial half dose from Italy showed stronger protection is intriguing. It may be caused by the immune system being primed more gradually, but the scientists can't yet explain it. Also, all the volunteers in this group were under 55.​

Ask the virus.

I must admit I am pessimistic about this vaccine. It is more for investors than any long term health outcome. Never before has a coronavirus vaccine been attempted, because the damn virus changes so quickly. It is Adaptation 101, the coronavirus.

I still await Covid-20 to be announced by the Chinese.

gg



 
Australian Government - Department of Health

Australia’s vaccine agreements

Australia has entered into 4 separate agreements for the supply of COVID-19 vaccines, if they are proved to be safe and effective.​
University of Oxford/AstraZeneca

Status​
Type​
Developer​
Likely Doses*​
Phase 3 clinical trials​
Viral vector vaccine​
AstraZeneca​
2​
  • *Based on early trial results
Novavax
Status​
Type​
Developer​
Likely Doses*​
Phase 3 clinical trials​
Protein vaccine​
Novavax Inc.​
2​
Pfizer/BioNTech
Status​
Type​
Developer​
Likely Doses*​
Phase 3 clinical trials​
mRNA-based vaccine​
Pfizer/BioNTech​
2​
COVAX Facility
The Australian Government has joined the COVAX Facility as part of a global effort to support rapid, fair and equitable access to COVID-19 vaccines. This participation enables us to purchase vaccine doses for Australia as they become available. Currently 188 countries around the world have entered into the COVAX Facility. The participation of countries like Australia means the facility can invest in a diverse portfolio of potential COVID-19 vaccines and support vaccine manufacturers. It is aiming to mobilise 2 billion doses for the world by the end of 2021, addressing the acute phase of the pandemic. COVAX is coordinated by Gavi with help from member countries, the Coalition for Epidemic Preparedness Innovations (CEPI), the World Health Organization, and UNICEF.​
Australia’s commitments to the COVAX Facility
The Australian Government has made 2 financial commitments to Gavi’s COVAX Facility for the supply of safe and effective COVID-19 vaccines:​
  • An upfront payment of $123.2 million to allow the purchase of over 25,000,000 doses of COVID-19 vaccines for the Australian population. This would be sufficient for 50 percent of the population to receive a 2 dose regimen.
  • A further $80 million to support vaccine access for up to 94 lower-income countries through the Facility’s Advanced Market Commitment.
Doses for Australia
Before any vaccines will be made available, they must be approved for use in Australia. This includes the Therapeutic Goods Administration’s (TGA) rigorous assessment and approval processes for safety, quality and effectiveness. The TGA is actively monitoring COVID-19 vaccine development that is occurring both in Australia and around the world.​
Potential COVAX Facility vaccines The following 9 vaccine candidates are in various clinical trial stages and, if found successful, will be included in the COVAX Facility.​
Developer​
Type​
Status​
AstraZeneca / University of Oxford​
Viral vector vaccine​
Phase 3 clinical trials​
Novavax​
Protein subunit vaccine​
Phase 3 clinical trials​
Moderna​
mRNA based vaccine​
Phase 3 clinical trials​
CureVac​
mRNA based vaccine​
Phase 2 clinical trials​
Sanofi / GSK​
Protein subunit vaccine P​
Phase 1/2 clinical trials​
Inovio​
DNA based vaccine Ph​
Phase 1/2 clinical trials​
Clover Biopharmaceuticals / GSK / Dynavax​
Protein subunit vaccine​
Phase 1 clinical trials​
Institut Pasteur / Merck / Themis​
Viral vector vaccine​
Phase 1 clinical trials​
University of Hong Kong​
Viral vector vaccine​
Preclinical​
Supporting our region
Access to safe and effective vaccines will play a critical role in the economic recovery of our region from this pandemic. Supporting our regional neighbours to access doses will progress health outcomes, and help open up movement of people and goods. This will enable economic recovery and longer-term resilience of the Pacific and South East Asia.​
.​
 
Moderna


The New England Journal of Medicine




Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine


Abstract
BACKGROUND
Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19.​
METHODS
This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2.​
RESULTS
The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups.​
CONCLUSIONS
The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427. opens in new tab.)​




 
Rubbish


Sinovac: Brazil results show Chinese vaccine 50.4% effective

A coronavirus vaccine developed by China's Sinovac has been found to be 50.4% effective in Brazilian clinical trials, according to the latest results released by researchers.​
It shows the vaccine is significantly less effective than previous data suggested - barely over the 50% needed for regulatory approval.​
The Chinese vaccine is one of two that the Brazilian government has lined up.​
Brazil has been one of the countries worst affected by Covid-19.​
Sinovac, a Beijing-based biopharmaceutical company, is behind CoronaVac, an inactivated vaccine. It works by using killed viral particles to expose the body's immune system to the virus without risking a serious disease response.​

Several countries, including Indonesia, Turkey and Singapore, have placed orders for the vaccine.

Last week researchers at the Butantan Institute, which has been conducting the trials in Brazil, announced that the vaccine had a 78% efficacy against "mild-to-severe" Covid-19 cases.

But on Tuesday they revealed that calculations for this figure did not include data from a group of "very mild infections" among those who received the vaccine that did not require clinical assistance.

With the inclusion of this data, the efficacy rate is now 50.4%, said researchers.

But Butantan stressed that the vaccine is 78% effective in preventing mild cases that needed treatment and 100% effective in staving off moderate to serious cases.

The Sinovac trials have yielded different results across different countries.

Last month Turkish researchers said the Sinovac vaccine was 91.25% effective, while Indonesia, which rolled out its mass vaccination programme on Wednesday, said it was 65.3% effective. Both were interim results from late-stage trials.

 
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