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By Atlantis
The readout of the phase 3 Janssen vaccine trial is expected for the end of January, which would get the vaccine approved by February. This will be the first 1-shot vaccine. If approved it'll substantially increase the available vaccine doses. The European Medicine Agency EMA already started the rolling review of the Janssen vaccine Dec. 1st.

Interim Results of Johnson & Johnson Single-Dose COVID-19 Vaccine Shows 90% Efficacy

2021-01-15 09:46:00

Johnson & Johnson’s (J&J) JNJ-78436735 COVID-19 vaccine was shown to be 90% efficacious in interim results, according to findings published in the New England Journal of Medicine. The single dose investigational vaccine, which is being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, is more commonly referred to as the Ad26.COV2.S vaccine, and is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike (S) protein.

After a single dose vaccination, data showed neutralizing antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100% of participants aged 18-55 years at Day 57. These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years. The company plans to release data in participants 65 years and older in late January.

The phase 1/2a analysis showed that the company’s COVID-19 vaccine candidate was generally well-tolerated across all study participants. While the vaccine is being studied as a single dose administration shot, the trial did evaluate 2 dose administration. The data showed that a second dose of JNJ-78436735, administered 56 days apart, was less reactogenic while it triggered more than a two-fold increase in antibodies against COVID-19.

“Although all ongoing phase 3 studies of other Covid-19 vaccines have assessed two-dose schedules, a single dose of Ad26.COV2.S elicited a strong humoral response in a majority of vaccine recipients, with the presence of S-binding and neutralizing antibodies in more than 90% of the participants, regardless of either age group or vaccine dose,” the investigators wrote.
By Atlantis
The Biontech/Pfizer vaccine works better than suggested by the trials.

“The Vaccine Works Wonderfully”: Preliminary Results Of Israeli Serological Study On Vaccine Efficacy

A study conducted among the hospital’s medical staff in Israel found that 100 out of 102 vaccinated workers developed high-level antibodies to the disease. Senior doctor: “Most vaccinated people have more antibodies than those who have recovered from the disease. Meaning: We will see the decrease in morbidity in the coming days.

The vaccinated will probably not be carriers, nor will they be contagious: this is the conclusion from the interim results of a study in Sheba Hospital. One week after receiving the second dose, there was usually a 6 to 20-fold increase in antibodies, with only two out of 102 vaccines developing almost no antibodies. “This means that the vaccine works wonderfully, and There is definitely a reason for optimism, ” said Prof. Regev-Yohai, who presented the results of the vaccine.

The data refer to 102 vaccinators at the hospital out of about a thousand Sheba Hospital employees who participated in the study so far and received the second dose of the corona vaccine.

Of those 102 people, only two developed very low-level antibodies, one of which was immunosuppressed.The vast majority have developed antibodies at very high levels. This means that we will begin to see the decline in morbidity because we see people with hundreds of high antibody levels,” added Prof. Regev-Yohai.
By Atlantis
Initial lab tests suggest that the Biontech/Pfizer vaccine is effective against the new British variant. Unless the virus starts to mutate like crazy, that indicates that the vaccine may be effective for years.

Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited human sera

Recently, a new SARS-CoV-2 lineage called B.1.1.7 has emerged in the United Kingdom that was reported to spread more efficiently than other strains. This variant has an unusually large number of mutations with 10 amino acid changes in the spike protein, raising concerns that its recognition by neutralizing antibodies may be affected. Here, we investigated SARS-CoV-2-S pseudoviruses bearing either the Wuhan reference strain or the B.1.1.7 lineage spike protein with sera of 16 participants in a previously reported trial with the mRNA-based COVID-19 vaccine BNT162b2. The immune sera had equivalent neutralizing titers to both variants. These data, together with the combined immunity involving humoral and cellular effectors induced by this vaccine, make it unlikely that the B.1.1.7 lineage will escape BNT162b2-mediated protection.
By Atlantis
The new South African variant can evade antibodies and may reduce vaccine efficacy. A minor reduction of efficacy from the 95% of mRNA vaccines may not be so bad, but it could make Sinovac or AstraZeneca useless because they only have 50% and 63% efficacy, respectively.

New COVID-19 variant defeats plasma treatment, may reduce vaccine efficacy

JOHANNESBURG (Reuters) - The new COVID-19 variant identified in South Africa can evade the antibodies that attack it in treatments using blood plasma from previously recovered patients, and may reduce the efficacy of the current line of vaccines, scientists said on Wednesday.

Researchers are racing to establish whether the vaccines currently being rolled out across the globe are effective against the so-called 501Y.V2 variant, identified by South African genomics experts late last year in Nelson Mandela Bay.

This lineage exhibits complete escape from three classes of therapeutically relevant monoclonal antibodies,” the team of scientists from three South African universities working with the National Institute for Communicable Diseases (NICD) wrote in a paper published in the bioRxiv journal.

Furthermore, 501Y.V2 shows substantial or complete escape from neutralising antibodies in COVID-19 convalescent plasma,” they wrote, adding that their conclusions “highlight the prospect of reinfection ... and may foreshadow reduced efficacy of current spike-based vaccines.”

The 501Y.V2 variant is 50% more infectious than previous ones, South African researchers said this week. It has already spread to at least 20 countries since being reported to the World Health Organisation in late December.

It is one of several new variants discovered in recent months, including others first found in England and Brazil.

The variant is the main driver of South Africa’s second wave of COVID-19 infections, which hit a new daily peak above 21,000 cases earlier this month, far above the first wave, before falling to about 12,000 a day.

Convalescent blood plasma from previous patients has not been shown to be effective when administered to severely ill patients requiring intensive care for COVID-19, but it is approved in several countries as an emergency measure.

British scientists and politicians have expressed concern that vaccines currently being deployed or in development could be less effective against the variant.

The paper said it remained to be seen how effective current vaccines were against 501Y.V2, which would only be determined by large-scale clinical trials. But results showed the need for new vaccines to be designed to tackle the evolving threat, it said.
By Atlantis
The question is: why aren't the Chinese releasing the technical data from their vaccine trials so they can be peer-reviewed. If they are as good as the Chinese claim, it would be an advantage to have the data confirmed by a third party.

Also, it's a myth that the Chinese vaccines are cheap. China provides them to "friendly" nations at a mate's price.

China's COVID-19 vaccines are being given the green light without the data being revealed. Why?
By Atlantis
It's impossible to reach herd immunity against the new British variant with low-efficacy vaccines like the Oxford vaccine. It'll be even harder to reach herd immunity with the Chinese Sinovac vaccine, which has even lower efficacy, against the Brazilian variant, which is even more dangerous.

The government vaccination programme may not be sufficient to achieve herd immunity - even if everyone in the UK is vaccinated - according to new research from the University of East Anglia.

Researchers modelled the effectiveness of UK-wide immunisation programmes using the Oxford and Pfizer vaccines, taking into account the highly transmissible new Covid-19 variant.

They found that the only way to reach herd immunity for the UK would be to vaccinate almost everyone – including children – with the more effective Pfizer vaccine.
They say data for the recently licenced Moderna vaccine would be similar to the Pfizer results.

And the study recommends that all health and social care professionals should receive the 95 per cent effective Pfizer/Moderna vaccines to prevent asymptomatic spread to patients and vulnerable people.

Due to the rapid response nature of this research it has not yet been peer reviewed.
Covid-19 expert Prof Paul Hunter, from UEA’s Norwich Medical School, said: “Getting vaccinated has a huge benefit to you personally. It greatly reduces the risk of serious illness and reduces your risk of symptomatic disease by an estimated 70 per cent for the Oxford vaccine, or 95 percent for the Pfizer and Moderna vaccines.

“But we wanted to find out whether ‘herd immunity’ is a realistic outcome of any immunisation programme with the main vaccines licenced in the UK given that immunisation, even though it can reduce illness, may not prevent all infections.

“And importantly, can these vaccines achieve a sufficient level of population immunity to reduce the reproductive R number to below one in the absence of any non-pharmaceutical interventions?”

The research team used mathematical models of Covid-19 transmission and vaccine efficacy to predict how well the Oxford and Pfizer vaccines will work to bring the R number down and achieve herd immunity.

They initially found that 69 per cent of the population would need to be vaccinated with the Pfizer vaccine, or 93 per cent of the population with the Oxford vaccine, to bring the R number below one.

However, when they took into account the new more transmissible Covid-19 variant, they found that vaccinating the entire population with the Oxford vaccine would only reduce the R value to 1.325. Meanwhile the Pfizer vaccine would require 82 per cent of the population to be vaccinated to control the spread of the new variant.

Modeller Prof Alastair Grant, from UEA’s School of Environmental Sciences, said: “The Oxford vaccine reduces the incidence of serious illness to a greater extent than it reduces symptomatic illness, which is still common in those who have had this vaccine.

“Its efficacy against the incidence of asymptomatic infections is lower, reducing its efficacy against all infection from 70.4 per cent to 52.5 per cent for the pooled data. This means that its overall protection against infection is only partial - around 50 per cent.
“Although asymptomatic cases are less infectious, including this in our calculations still raises R values by 20 per cent or more, from 1.33 to 1.6 for the new variant with a 100 per cent vaccination.

“This combination of relatively low headline efficacy and limited effect on asymptomatic infections means that the Oxford vaccine can't take us to herd immunity, even if the whole population is immunised.

“Vaccinating 82 per cent of the population with the Pfizer vaccine would control the spread of the virus - but it isn't licenced for use on under 16s, who make up 19 per cent of the population.

“Also, some people will refuse the vaccine, so achieving an 82 per cent vaccination rate will likely be impossible. In the absence of vaccination, ‘herd immunity’ would only occur when 89 per cent of the population has had the virus.”

Prof Grant added: “We know that a substantial fraction of those who have been vaccinated or have had a natural infection can still become infected and pass the virus on others.

“It is very worrying that vaccinated but asymptomatically infected people could still pass Covid-19 on to those who have not been vaccinated, and particularly those who may be immunocompromised.

“For this reason, we recommend that health and social care workers, and others who have lots of contacts with those vulnerable to infection, should receive one of the mRNA vaccines in preference.

“The Oxford vaccine will no doubt be an important control intervention, but unless changes to the dose regime can increase its efficacy, it is unlikely to fully control the virus or take the UK population to herd immunity.”

Prof Hunter added: “If we cannot achieve herd immunity, vulnerable unvaccinated individuals will remain at risk. We do need to consider how best to protect these individuals when social restrictions are eventually relaxed as the result of a successful vaccine roll out programme.”

Prof Hunter was funded by the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Emergency Preparedness and Response at King’s College London in partnership with Public Health England (PHE) and collaboration with the University of East Anglia.

University of East Anglia
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By MistyTiger
Vaccinating 82% of the population sounds like an impossibility or a multi-year effort. I could see it taking 3-4 years to make that happen. There is a lot of skepticism about the effectiveness and the need for vaccination. Plus, the current rate of production is behind the demand. Production needs to be increased, like maybe the vaccine needs to be created around the clock, the machines will be constantly running with very little down time.

In the meantime, how long till life returns to some sort of normal? How long can we keep up the WFH policy? How long can restaurants and other contact-reliant businesses survive in such a limited capacity?
By Atlantis
MistyTiger wrote:Vaccinating 82% of the population sounds like an impossibility or a multi-year effort. I could see it taking 3-4 years to make that happen. There is a lot of skepticism about the effectiveness and the need for vaccination. Plus, the current rate of production is behind the demand. Production needs to be increased, like maybe the vaccine needs to be created around the clock, the machines will be constantly running with very little down time.

In the meantime, how long till life returns to some sort of normal? How long can we keep up the WFH policy? How long can restaurants and other contact-reliant businesses survive in such a limited capacity?

Last summer, most experts were still predicting that it would take at least 18 months to develop a vaccine. It's a miracle that we have a vaccine in 11 months. It's an even greater miracle that the two frontrunners have 95% efficacy.

If governments want more vaccines faster, they should have invested more in production facilities 6 months ago. They didn't because nobody knew which vaccine would succeed and which vaccine would fail.

GSK/Sanofi has already dropped due to low efficacy. Everybody expected GSK/Sanofi to be successful because these are two of the biggest pharma companies worldwide. In the end, it was small innovative startups like Biontech and Moderna that succeeded while big companies failed. Biontech and Moderna were able to rapidly develop a high-efficacy vaccine based on mRNA carrier technology that has been developed for 20 years primarily for cancer treatment.

Rather than starting new production facilities now, it's better to wait for the dozens of other vaccines that are scheduled to arrive in the coming months and for which production is already in the planning and/or existing. We don't know which vaccine will be best in the end.

Once production facilities for the mRNA vaccine have been built up, it'll be easy and cheap to produce large amounts of vaccine. They can also be rapidly adapted to new variants in about 6 weeks.

The scientists and engineers have succeeded where politicians failed. Now left-wing politicians want to punish the inventors by disowning them so that they won't be able to develop any new technology.
By late
Atlantis wrote:
Now left-wing politicians want to punish the inventors by disowning them so that they won't be able to develop any new technology.

Is there something I am missing here?

Which politicians, and what are they doing?

This isn't relevant to this thread, but based on the new research, the USA could reach a million dead by the end of the year. Hope I am wrong about that.
By Atlantis
late wrote:Is there something I am missing here?

You would if you are based in the US since you don't have a left, not in the proper sense of the term.
By Atlantis
Following GSK/Sanofi, the French Pasteur Instituted, which had partnered with Merck, also dropped out of the Covid vaccine race. The Institute continues research on two other Covid vaccines; however, vaccine candidates that haven't completed enrolling participants for their phase 3 trials will find it difficult to do so now since the first successful vaccines are being deployed. Especially the elderly are unlikely to risk participating in a double-blinded trial in which they may get the placebo.

France’s Pasteur Institute says it is abandoning its principal Covid-19 vaccine project

"In these first human trials, the prospective vaccine was well tolerated but produced immune responses that were inferior to those observed in people who had recovered naturally and to those observed in the authorised vaccines,"

Sanofi and the Pasteur Institute both dropped out because of low efficacy. Covid vaccines with less than 90% efficacy don't stand a chance. AstraZeneca and Sinovac are continuing despite low efficacy because they are used as means for geopolitical influencing, which may prove to be counterproductive.

The Russian Sputnik V also claims to reach 90% efficacy. They have applied for approval with the EU's EMA a week ago. It'll be interesting to see if the high efficacy can be confirmed.
By Atlantis
AstraZeneca has now been approved in the EU; however, the US approval isn't expected before April. Days before getting EU approval the company announced that it could only deliver 1/3 of the contractual amount due to a massive production shortfall. That is delaying vaccination in Europe. The European regulator approved AstraZenca for an efficacy of 60% for all ages above 18; however, a number of national agencies have already said that they aren't going to use it for the elderly because of lack of data.

In addition to Biontech/Pfizer, Moderna and Astrazeneca, which have been approved, Janssen and Novavax have also announced their 3rd phase results. Janssen which is another vector DNA vaccine like AstraZeneca also had low efficacy. It's advantage is that it is a 1-shot vaccine. Novavax had good results in its UK trial (86% efficacy); however, the South African trial was very low with 49% efficacy, probably due to exposure to the new variant.

Since the GSK/Sanofi vaccine has already flopped, that only leaves CureVac as the last of the EU's vaccines in phase 3 trials that's due for readout in March. After its agreement with Bayer for producing the Curevac vaccine currently in p3 trials, Curevac has also announced an agreement with GSK for producing its booster vaccine against new variants at its plant in Belgium.

Sputnik V has also applied for approval in the EU, but I think this is just a political move to get recognition for the Russian vaccine because they probably don't have the production capacities to deliver substantial quantities to the EU.

Hungary received some vaccines from Russia and China, but I don't think the Chinese will get their vaccine approved by the European regulator.
By Atlantis
South Africa has stopped using the AstraZeneca vaccine because it found in a small trial that the vaccine only provides protection against mild and moderate infection of 10% in an environment in which the new South African variant B.1.351 has spread. The country is considering swapping or selling the vaccine.

The British virus variant B.1.1.7 has mutated again. There were several cases of the virus in the Bristol and Manchester regions that had acquired the E484K mutation, which is also known from the SA and Brazilian variants. This mutation has the ability to avoid antibodies from previous infections or vaccines, which may lead to lower vaccine efficacy and reinfection. SARS-CoV-2 mutations seem to converge on a single pathway independently of one another in different parts of the world.

Experiments show that a variant with the N501Y, E484K and S447N mutation binds 600 times stronger to the human ACE2 receptors, which increases viral load, transmissibility and severity of infection. The good new is that this combination of mutations can also be used to make a powerful vaccine.

Biontech has opened a 3rd production facility for its mRNA vaccine in Marburg, Germany. The plant is the biggest worldwide and should produce 750 million doses a year. Biontech also has cooperation agreements with Dermapharm to produce vaccines in Bavaria, with the US company Baxter to produce vaccines in Halle and the French company to produce vaccines in Frankfurt, both in Germany.

Sputnik is in talks with a company in East Germany to produce the Russian vaccine; however, considering the holes in the published Sputnik data and the absence of the raw data, I doubt that Sputnik V will be used in the EU, aside from Hungary of course.
By Atlantis
According to data from Israel, the Biontech/Pfizer vaccine performs as well in the real world as in the trials:

Covid-19: Vaccine as good in 'real world' as in trial in Israel

Israel's largest health fund Clalit looked at positive tests in 600,000 vaccinated people and the same number of unvaccinated people, matched by age and health status.

It found 94% fewer infections among the vaccinated group.

This was based on test results in people's medical records, usually taken if they had symptoms or were a close contact of someone who had tested positive.

And the vaccine prevented almost all cases of serious illness.

This pattern was the same in all age groups - including the over-70s, who may have been under-represented in clinical trials.

Things couldn't be different for the "Oxford vaccine" from AstraZenca. Several countries have reported side-effects in an unusually high number of vaccinated in Sweden, France, Germany and Austria. Switzerland has delayed approval because of lack of data and most EU countries and South Korea have decided not to use it for the elderly.

'In science we don't go for the second-best option': Health ombud Makgoba speaks out on AstraZeneca vaccine

SA health ombud and molecular immunologist Prof Malegapuru Makgoba is fiercely opposed to the rollout of the AstraZeneca Covid-19 vaccine in SA, saying that from a scientific and public health point of view it would be irrational.

“The AstraZeneca vaccine is not efficacious. It was efficacious against the original, wild virus but it is not against the variant dominant in SA,” he said.

The new variant, known as B1.351 or 501Y.V2, is the current dominant variant in SA.

“Both the government and scientists have made the right decision and done what is scientifically acceptable by pausing the rollout,” he said.

Makgoba said the Johnson & Johnson Covid-19 vaccine was the only one proven to be efficacious against B1.351 in a clinical study — offering 57% protection. The others have not undergone such a clinical trial.

“The AstraZeneca vaccine is way below this (at 22%) and significantly below the 50% minimum efficacy threshold required by the FDA. In science we don’t go for the second-best option,” he said.

Considering the low efficacy of AstraZeneca against the new variants, it'll be impossible to reach herd immunity with this vaccine since the new variants are bound to become dominant in the coming months.

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