COVID COVID-19 Vaccine Progress: Are We Ready for Rollout in Australia?

[Astronuc]

A family friend, who works as a physician's assistant (and who was vaccinated), informed us last night that two vaccinated co-workers have tested positive for COVID-19. One had received the vaccine in January, but now has COVID-19 symptoms, which the person thought was a sinus infection. The vaccine may lessen the severity of the infection, but time will tell how many vaccinated folks respond to the COVID infection.

We also learned that some long haulers respond positively to the vaccines, i.e., they improve over time.

Update: https://www.businessinsider.com/sou...r-moderna-covid-vaccine-study-mutation-2021-3

Claims:

COVID-19 vaccines from Moderna and Pfizer-BioNTech appear significantly less effective against the Coronavirus variant first found in South Africa, a lab study has suggested.

The percentage of protective antibodies that neutralized the variant - called B.1.351, which has been recorded in 20 US states - was 12.4 fold lower for Moderna's COVID-19 shot than against the original coronavirus, and 10.3 fold lower for Pfizer's, the study authors said.

This was a bigger drop than in previous lab studies testing the vaccines against manufactured forms of the variant, they said. For this study, the researchers used real forms of the variant taken from people who had caught the virus.

Antibody Resistance of SARS-CoV-2 Variants B.1.351 and B.1.1.7
https://www.nature.com/articles/s41586-021-03398-2_reference.pdf

As far as I know, both Pfizer and Moderna have expressed concern about the variants and are looking at a third booster shot, perhaps with a tweek related to E484K mutation.

I one has a chance to get the vaccine, do so. I'm eligible as of tomorrow.

 

[Ygggdrasil]

AstraZeneca released the results of its Phase 3 clinical trial for the AZD1222/ChAdOx1 vaccine that it developed with Oxford University. The trial consisted of 32,449 individuals from the US, France, Chile and Peru, 2/3 of whom received the vaccine and 1/3 of whom received a placebo. The vaccine is an adenoviral vector vaccine like the Johnson & Johnson and Russian Sputnik vaccines.

The two-dose vaccine reduced symptomatic disease by 79%, the company said in a press release, and reduced severe Covid-19 and hospitalization by 100%. AstraZeneca said that the vaccine was equally effective in people over 65, where it had 80% efficacy.

Two volunteers in the study received vaccine for every one that received placebo. Across the study, 141 had symptomatic Covid-19 and five, all in the placebo group, had severe disease.

https://www.statnews.com/2021/03/22...s-better-than-expected-efficacy-in-u-s-trial/

Given the recent concern over blood clots from the vaccine in Europe, the company reviewed trial data for thrombosis and found no increased risk of thrombosis. However, the severe thrombosis events reported in Europe were sufficiently rare that they would be unlikely to be detected in a trial with only ~22,000 vaccinated individuals.

Unfortunately, the results have only been disclosed via a press release from the company. The actual data for the trial are not yet available.

AstraZeneca Press release: https://www.astrazeneca.com/media-c...ca-us-vaccine-trial-met-primary-endpoint.html
Popular press coverage: https://www.statnews.com/2021/03/22...s-better-than-expected-efficacy-in-u-s-trial/
Published phase 2 clinical trial results for the vaccine: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext

 

[bhobba]

However, the severe thrombosis events reported in Europe were sufficiently rare that they would be unlikely to be detected in a trial with only ~22,000 vaccinated individuals.

I tried to explain this to my sister yesterday and she just kept saying how do you know. I said the UK did not stop their mass vaccination - all she could say - why did the other countries stop. At that point I gave up. But it still had an 'effect' on her - she only wants the vaccine towards the end of the rollout in Aus now. As far as I know no such 'events' have occurred in the UK where they have vaccinated 28 million people, most with the Oxford vaccine. So it must be very rare.

Thanks
Bill

 

[PeroK]

I tried to explain this to my sister yesterday and she just kept saying how do you know. I said the UK did not stop their mass vaccination - all she could say - why did the other countries stop?

Why did they start again? The EU's actions logically ought to give more confidence. One could argue that the UK might have ignored risks to get the vaccinations going quickly. Whereas, the EU's actions suggest that if there were a risk with the vaccines they would stop.

If there were a serious, known risk with the AZ vaccine, the EU would not have started using it again.

 

[Ygggdrasil]

A safety board overseeing AstraZeneca's COVID-19 vaccine trial is raising concerns about the company's data. In an unusual post-midnight statement, the National Institute of Allergy and Infectious Diseases said the Data and Safety Monitoring Board, which monitors the trial, is concerned "outdated information" may have been included in the trial results.

If the pharmaceutical company did include outdated information from that trial, that could provide an "incomplete view of the efficacy data," the NIAID said.

The DSMB, an independent group within the agency responsible for reviewing clinical studies, also notified other federal health agencies and AstraZeneca directly of its concerns.

Later Tuesday, AstraZeneca released a statement saying that its interim analysis was based on data with a "cut off" of Feb. 17 and that it had "reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis." The company said it expected to release results of its primary analysis within 48 hours.

https://www.npr.org/2021/03/23/9802...vaccine-trial-data-questioned-by-safety-board

NIAID press release: https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine
AstraZeneca press release: https://www.astrazeneca.com/content...niaid-on-azd1222-us-phase-iii-trial-data.html

 

[Astronuc]

In 2020, Covid-19 vaccines shattered previous speed records, going from development to FDA approval in less than one year. Before that, the fastest vaccine to receive FDA approval in the US was the mumps vaccine, which took four years. So how did they do it? Vaccines including those from Pfizer/BioNTech, Moderna, Johnson & Johnson, and AstraZeneca used new methods that give genetic instructions directly to human cells.

https://www.vox.com/2021/2/2/22262226/covid-19-vaccines-mrna-adenovirus

 

[Ygggdrasil]

AstraZeneca's latest data analysis affirms effectiveness of its COVID-19 vaccine and is roughly in line with the results released Monday.

The latest analysis finds the vaccine to be 76% effective against symptomatic COVID-19 and 100% effective against severe or critical disease and hospitalization. These results are very close to the results that came out at the beginning of the week: 79% vaccine efficacy at preventing symptomatic COVID-19 and 100% effective against severe or critical disease and hospitalization.

An independent monitoring board raised questions about the company's release Monday — a day after the company announced that the higher efficacy rate -- saying it didn't include more up-to-date cases that were available.

https://www.npr.org/2021/03/24/9810...eport-supports-effectiveness-of-covid-vaccine

AstraZeneca press release: https://www.astrazeneca.com/content...ry-analysis-confirms-safety-and-efficacy.html

The 76% effectiveness presented by the company still seems slightly higher than effectiveness estimates quoted from the Data Safety and monitoring Board who also reviewed the data and saw 69-75% effectiveness.

In a memo sent to company and government officials, obtained by The Washington Post, experts who have been overseeing the vaccine trial expressed concern and disappointment that the drugmaker had presented “outdated and potentially misleading” data on its Coronavirus vaccine, making the shots appear more effective than shown by fuller data.

On Monday, AstraZeneca and academic scientists trumpeted a vaccine that was 79 percent effective in its large U.S. clinical trial. That news release triggered concern among independent monitors who had seen more recent data, because when an additional month was taken into account, the effectiveness ranged from 69 to 75 percent.

The letter came from 11 leading statisticians, infectious-disease physicians and ethics experts appointed by the National Institutes of Health to review trial data for all the major Coronavirus vaccines supported by the federal government.

https://www.washingtonpost.com/worl...931d34-8bc3-11eb-a33e-da28941cb9ac_story.html

 

[Klystron]

After being too young by one year for the initial public vaccine program in southern Nevada USA, I received the Pfizer vaccine first dose this week at our local veteran's hospital after minimum age reduction from 70 to 65 years old. Second dose scheduled in 21 days.
{snip}

Received my second dose of Pfizer vaccine 24 March from the VA hospital. I felt fine afterward, only tired from the long drive. Normal~8 hour sleep. No unusual pain. I felt tired and groggy for a week after first dose.

I felt exceptionally good the following day. Cleaned home including vacuuming and steam cleaning new floors installed after water leak repaired; activity that would normally exhaust me. Attended two hour late virtual meeting via Zoom with no loss of attention. Slept ~7 hours.

Attended physical therapy today (day 3). Felt energetic. Completed entire exercise schedule followed by weekly grocery shopping. Noticed no ill effects from vaccine; rather the opposite. Either I am experiencing a profound placebo impact, or the second dose has made me feel much better than before.

 

[bhobba]

Why did they start again? The EU's actions logically ought to give more confidence.

Of course. But, especially with regard to Covid, people's logic sometimes seems 'compromised'. I am starting to reach the conclusion best not to discuss Covid except here and with my doctors. Not there yet - but it may come. Personally the huge number of Oxford vaccines given showed if it was an issue it was very very rare and there was no need to stop. Just my view - there is public perception to consider, which I think is why it really was temporarily halted to investigate the issue. But I am not the one in charge of these things who must take many factors including public confidence into consideration.

Interesting development with the Oxford vaccine in the US I will do a separate post about.

Thanks
Bill

 

[bhobba]

The 76% effectiveness presented by the company still seems slightly higher than effectiveness estimates quoted from the Data Safety and monitoring Board who also reviewed the data and saw 69-75% effectiveness.

You stole my thunder. . I was going to do a separate post about it:

It will almost certainly eventually be approved in the US, and since the US has 300 million doses on order, will help greatly with the mass vaccination there. I have noticed AstraZenica tends to 'hype' the Oxford vaccine in their press releases which means one really must read the preprint to get the full picture. Not a good way of doing things - it just creates 'doubt' - the last thing you want in a pandemic - and slows down approvals.

The trial was with the second dose after 4 weeks. But we know, from UK data where nearly 30 million doses have been given (total vaccinations - predominantly Oxford but some Pfizer and recently Modernia) it has a 73% effectiveness after 35 weeks with just one dose, but only 80% effective in preventing hospitalisations. When given the second dose, which has not been done in the UK yet, so no large scale data is available, trials showed it is 100% effective in preventing hospitalisations. But if you wait 12 weeks there is evidence the effectiveness against getting Covid rises to 83%, with still 100% effectiveness in preventing hospitalizations. To wait to give the second dose at 12 weeks or 4 weeks is the question. Decisions, decisions. Here in Aus they will be using 12 weeks. I suspect because we just a few hours ago detected our first case of community transmission in a long time:
https://www.sbs.com.au/news/new-bri...was-infectious-in-community-for-almost-a-week

This locking down of disability services causes people (including me) quite a bit of difficulty - but they seem able to get by. People generally are helpful. In my case, luckily, before the lockdown my house was cleaned yesterday.

Thanks
Bill

 

[Borg]

I have been checking out the vaccination rates in Fairfax County, VA for the last three weeks and have watched it climb from 21K doses received per week, to 32 last week, to over 43K this week. Meanwhile, their waitlist has been cut in half during that same time.

 

[Astronuc]

AstraZeneca and rare thrombosis
https://www.usatoday.com/story/news...ood-clots-not-definitively-linked/4721828001/

In early March, reports of cases involving blood clots, abnormal bleeding and low blood platelets – a few fatal – led many European countries to temporarily suspend AstraZeneca-Oxford's COVID-19 vaccine, which is not available in the U.S. The European Union's drug regulatory agency, European Medicines Agency, later said the vaccine did not increase the overall incidence of blood clots and that the benefits of using it outweighed the possible risks. Vaccines are not known to cause blood clots although there have been cases of immune thrombocytopenia, a rare condition marked by low platelets, following vaccination with Moderna's and Pfizer's COVID-19 vaccines.

The article did not provide a definitive statement on the cause of clotting with vaccines, only that rare cases have been reported.

https://www.dw.com/en/astrazeneca-german-team-discovers-thrombosis-trigger/a-56925550
https://www.dw.com/en/astrazeneca-whats-the-deal-with-thrombosis/a-56901525

Forbes is the only news source I found that states the cause and treatment.
https://www.forbes.com/sites/rachel...azenecas-vaccine-is-causing-rare-blood-clots/

Scientists at Greifswald University Hospital said in a statement Friday that in rare instances, the vaccine has created an antibody that triggered the formation of blood clots in the brain.

The findings confirm those from an independent team in Norway earlier this week.

Isolating the cause has allowed scientists to identify how to treat patients who have developed the blot clots, by giving them intravenous immunoglobulin, which targets the antibody, and blood thinners.

 

[Ygggdrasil]

New data from a phase 3 clinical trial of the Pfizer-BioNTech vaccine in adolescents (aged 12-16) suggests that the vaccine is effective in that age group:

The Phase 3 trial enrolled 2,260 adolescents who were randomly assigned to receive two doses of the vaccine or placebo. The main measure of the vaccine’s efficacy was whether a subset of subjects developed antibodies at the same level seen in older adolescents and adults. The antibody levels, expressed as SARS-CoV-2 neutralizing geometric mean titers, were 1,239.5, compared to geometric mean titers of 705.1 in subjects between the ages of 16 and 25 in previous studies. Those levels are considered non-inferior to one another.

But the vaccine also prevented symptomatic Covid-19 infection. There were 18 cases of Covid-19 among patients who received placebo and none in those who received the vaccine, the companies said.

https://www.statnews.com/2021/03/31/pfizer-covid19-vaccine-adolescents-data/

Pfizer press release: https://www.pfizer.com/news/press-r...ech-announce-positive-topline-results-pivotal

In the US, the FDA's emergency use authorization allows use of the vaccine only in those age 16 and over. These data could lead the FDA to expand the EUA to allow use of the vaccine in those age 12 and over. There are also trials underway testing the vaccine in children ages 6 mo - 11 years.

 

[Laroxe]

AstraZeneca and rare thrombosis
https://www.usatoday.com/story/news...ood-clots-not-definitively-linked/4721828001/
The article did not provide a definitive statement on the cause of clotting with vaccines, only that rare cases have been reported.

https://www.dw.com/en/astrazeneca-german-team-discovers-thrombosis-trigger/a-56925550
https://www.dw.com/en/astrazeneca-whats-the-deal-with-thrombosis/a-56901525

Forbes is the only news source I found that states the cause and treatment.
https://www.forbes.com/sites/rachel...azenecas-vaccine-is-causing-rare-blood-clots/

This addresses the possible mechanisms in more detail and identifies other diseases and sometimes their vaccines that are associated with coagulopathies. In Covid 19 infection, it is surprisingly common but is strongly associated with the severity of the disease, there are also quite a range of issues that are known to increase risk though these shouldn't play a part post vaccination. Its interesting that the group identified as most at risk is not concordant with the disease risk, this suggests a rather different sort of pathology. The first link describes the possible pathology in the actual disease.

The second link is more specific to the current situation and offers some comparisons between vaccines.
The fact that this risk has been identified as being associated with Covid 19 does mean that there is much more screening being used and that may account for some of the differences in the numbers recorded. The fact that these adverse events seem more common in young women and typically within 14 days of vaccination seems to support the idea that it is an autoimmune response.

With these details in mind and in view of the recommendations of various scientific advisory groups, there is no doubt that this is an issue that needs to be closely monitored. However being a devout cynic I thinks its impossible to make much sense of the various responses to restrict the vaccine yet again, without putting the situation in context. Politicians across Europe have been engaged in promoting misinformation in relation to the AZ vaccine as part of their dispute with the company and by proxy the UK. Despite their complaints their own efforts have lead to a situation in which around a third of the doses delivered have yet to be given and they are threatening the whole of the global supply of vaccines.
The data being used is derived from the various passive reporting systems used to monitor adverse events, the same data that anti vax groups misrepresent to promote their views.

In reality, thromboembolic events have been reported as potential adverse events for AZ, Pfizer and Moderna vaccines at similar rates. Reporting systems in the US which doesn't use the AZ vaccine have recorded some 150 such events. The yellow card system in the UK suggests that in the adverse event reports for the AZ and Pfizer vaccines the numbers are very similar. In the UK where large numbers of vaccinations have been carried out there is no indication that blood clots are occurring more frequently, in fact there appears to be a negative correlation. This is something various groups have identified in their risk assessments.

The final link is to the Canadian advisory body which has said that Overall, https://www.canada.ca/en/health-canada/news/2021/03/health-canada-confirms-that-the-benefits-of-the-astrazeneca-covid-19-vaccine-continue-to-outweigh-the-risks-for-use-in-canada.html that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risks, before the government introduced more control over its use. These restrictions are being introduced as case numbers and deaths from the disease are increasing and dissent in Europe in particular, growing.

https://thorax.bmj.com/content/76/4/412

https://www.bmj.com/content/372/bmj.n699

https://www.cbc.ca/news/health/faq-covid-astrazeneca-vaccine-blood-clots-1.5959447

 

[Astronuc]

Over 100 Washingtonians became ill with Coronavirus despite vaccinations, DOH says
https://keprtv.com/amp/news/local/o...got-coronavirus-despite-vaccinations-doh-says

I heard 102 persons who had been fully vaccinated contracted the SARS-Cov2 and developed COVID-19. Of those, 8 are hospitalized. The details are not yet available, but hopefully, we'll find out the vaccine, the demographics and how severe the illness. Nevertheless, everyone should continue to wear a mask and socially distance to the extent possible in public.

Out of one million fully vaccinated individuals in Washington state, epidemiologists report evidence of 102 breakthrough cases since February 1, 2021, which represents .01 percent of vaccinated people in Washington. Breakthrough cases have been identified in 18 counties. The majority of those in Washington state with confirmed vaccine breakthrough experienced only mild symptoms, if any. However, since February 1, eight people with vaccine breakthrough have been hospitalized. DOH is investigating two potential vaccine breakthrough cases where the patients died. Both patients were more than 80 years old and suffered underlying health issues. Further investigation will help to identify patterns among people who have COVID-19 after vaccination, such as if a virus variant may have caused the infection.

 

[Astronuc]

Johnson & Johnson COVID-19 vaccine batch fails quality check
https://apnews.com/article/health-c...irus-vaccine-05ac1d5c84c2945d48fd179c2733e84e

Ouch!

A vaccine ingredient made by Emergent BioSolutions — one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, J&J said.

J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine. Emergent declined to comment.

 

[Ygggdrasil]

Here's a nice article describing efforts to develop a universal Coronavirus vaccine that would protect against multiple variants of the virus and potentially even new zoonotic coronaviruses that could emerge in the future:

Instead of using the spike protein of SARS-CoV-2, which is prone to mutations, as the key target for Coronavirus vaccines, researchers are assessing other parts of the virus that are known to be more stable.

For example, scientists at the University of Nottingham in the UK are working alongside pharmaceutical company Scancell and Nottingham Trent University to test its COVID-19 vaccine candidate, SN14, which targets both the spike protein as well as the nucleocapsid, or N-protein. By targeting this additional viral structure, which is far less likely to mutate, the vaccine if found safe and effective could work to protect people against COVID-19 irrespective of any mutations to the spike protein and, in theory, could work across other coronaviruses.

Elsewhere, CalTech in the US have engineered a prototype all-in-one vaccine using a nanoparticle to hold fragments of the spike protein from multiple known coronaviruses. The innovative platform was found to trigger the production of antibodies against several coronaviruses in preclinical testing last month. Importantly, it not only protected against the Coronavirus antigens in the vaccine but also against related strains, suggesting an immune response had recognised common features across coronaviruses. This approach could therefore provide protection against newly emerging coronaviruses in the future.

Another approach, suggested in a recent Nature commentary, could be to look at whether broadly neutralising antibodies, known to work against multiple HIV strains, also exist for coronaviruses.

https://www.gavi.org/vaccineswork/going-universal-search-all-one-coronavirus-vaccine

These vaccines are still in the early stages of research, so they're unlikely to help with the current pandemic. However, given that we've seen three new coronaviruses emerge to cause outbreaks in people in the past two decades (SARS in 2002, MERS in 2012 and SARS-CoV-2 in 2019), vaccines and therapeutics that act broadly against multiple different strains of coronaviruses are definitely something that would be of great use in preventing future pandemics.

 

[Rive]

These vaccines are still in the early stages of research, so they're unlikely to help with the current pandemic.

I wonder if those attempts would work with the spike being front, in the way...


By the way, are there any news about vaccine modifications against the new mutations? Or maybe about polyvalent vaccines?
Even if it's early right now, it would worth to know if the existing vaccines can be safely modified this way.
Some proactivity instead of just passively reacting to events...

 

[Ygggdrasil]

I wonder if those attempts would work with the spike being front, in the way...By the way, are there any news about vaccine modifications against the new mutations? Or maybe about polyvalent vaccines?
Even if it's early right now, it would worth to know if the existing vaccines can be safely modified this way.
Some proactivity instead of just passively reacting to events...

Because of the nature of the mRNA vaccines, it is extremely quick to design new vaccine candidates once we have genetic sequence information for the virus. For example, Moderna designed its mRNA vaccine candidate just 2 days after the genetic sequence of the SARS-CoV-2 virus was made publicly available.

Both Pfizer and Moderna have initiated clinical trials to test booster shots of their vaccines aimed at providing immunity to some of the new strains that seem to evade antibody-based immunity (e.g. the B.1.351 variant). The FDA has said that these vaccines would undergo a review process similar to those given to annual flu vaccines such that they could be approved for use in the fall, if all the data look good.

https://www.nih.gov/news-events/new...ating-moderna-covid-19-variant-vaccine-begins
https://www.pfizer.com/news/press-r...iontech-initiate-study-part-broad-development

It is likely that the other vaccine manufacturers have begun testing vaccines against some of the new variants as well. These companies are definitely being proactive in trying to keep pace with the evolution of the virus (indeed, proactive R&D done in the previous decade by companies like Moderna through efforts like CEPI that fund epidemic preparedness are one reason why vaccines were able to be developed and approved so quickly).

 

[Mary Conrads Sanburn]

NEWS RELEASE 16-APR-2021

Study shows past COVID-19 infection doesn't fully protect young people against reinfection

THE MOUNT SINAI HOSPITAL / MOUNT SINAI SCHOOL OF MEDICINE

Although antibodies induced by SARS-CoV-2 infection are largely protective, they do not completely protect against reinfection in young people, as evidenced through a longitudinal, prospective study of more than 3,000 young, healthy members of the US Marines Corps conducted by researchers at the Icahn School of Medicine at Mount Sinai and the Naval Medical Research Center, published April 15 in The Lancet Respiratory Medicine.

"Our findings indicate that reinfection by SARS-CoV-2 in health young adults is common" says Stuart Sealfon, MD, the Sara B. and Seth M. Glickenhaus Professor of Neurology at the Icahn School of Medicine at Mount Sinai and senior author of the paper. "Despite a prior COVID-19 infection, young people can catch the virus again and may still transmit it to others. This is an important point to know and remember as vaccine rollouts continue. Young people should get the vaccine whenever possible, since vaccination is necessary to boost immune responses, prevent reinfection, and reduce transmission."
[ . . . ]
###

This work was supported by the Defense Health Agency through the Naval Medical Research Center and the Defense Advanced Research Projects Agency.
https://www.eurekalert.org/pub_releases/2021-04/tmsh-ssp041621.php

 

[berkeman]

Sorry if this has been asked and answered already, but what has to happen for each of the COVID vaccines to progress from the Emergency Use Authorization (EUA) stage to full approval? It seems like that is one of the most frequent reasons give by (fairly reasonable) people for not getting vaccinated yet. They don't like getting a vaccine under an EUA and would only consider it if fully approved. Probably getting full approval would help to boost the numbers of folks getting vaccinated and help us get closer to herd immunity...

 

[Vanadium 50]

I don't know the details of the process, but in the past it has taken years.

The argument you might use is "Once it's approved, they can start charging for it. I wonder how many hundreds of dollars the co-pay will be."

 

[Astronuc]

Apparently, CVS, Walgreens have wasted hundreds of thousands of Covid vaccine doses, data show
https://www.nbcnews.com/health/heal...s-thousands-covid-vaccine-doses-data-n1266032

There were logistical issues early on.

 

[Vanadium 50]

I have to say that article is very confused as to which numbers go where, and what is ordinary loss and what is Deaths We Can Blame on Trump. Walgreens, as far as I can tell has been able to get 99.5% of vaccines into people's arms, and most of the loss happened at the beginning. That 0.5% is compared to governmental numbers which are spotty at best.

To me, 0.5% sounds pretty good. Especially with no-shows. Out of 8 million doses, Walgreens is responsible for the US vaccination effort to fall behind by a grand total of 15 minutes. (i.e. 1% of a day) In project management terms, that's an SPI of about 0.99994.

 

[berkeman]

Sorry if this has been asked and answered already, but what has to happen for each of the COVID vaccines to progress from the Emergency Use Authorization (EUA) stage to full approval? It seems like that is one of the most frequent reasons give by (fairly reasonable) people for not getting vaccinated yet. They don't like getting a vaccine under an EUA and would only consider it if fully approved. Probably getting full approval would help to boost the numbers of folks getting vaccinated and help us get closer to herd immunity...

Looks like Pfizer just applied for full approval:

https://www.cnn.com/2021/05/07/health/pfizer-biontech-fda-approval-bla-vaccine/index.html

Pfizer/BioNTech seek full FDA approval for their Covid-19 vaccine​

 

[Ygggdrasil]

Promising news on the vaccine front: Researchers working to develop a more universal Coronavirus vaccine have shown in animal experiments that their vaccine candidate is broadly protective across a number of bat coronaviruses including the original SARS, SARS-CoV-2 and the major SARS-CoV-2 variants.

Neutralizing antibody vaccine for pandemic and pre-emergent coronaviruses
Saunders et al. Nature 2021
https://www.nature.com/articles/s41586-021-03594-0

Abstract:

Betacoronaviruses (betaCoVs) caused the severe acute respiratory syndrome (SARS) and Middle East Respiratory Syndrome (MERS) outbreaks, and the SARS-CoV-2 pandemic1–4. Vaccines that elicit protective immunity against SARS-CoV-2 and betaCoVs circulating in animals have the potential to prevent future betaCoV pandemics. Here, we show that macaque immunization with a multimeric SARS-CoV-2 receptor binding domain (RBD) nanoparticle adjuvanted with 3M-052/Alum elicited cross-neutralizing antibody (cross-nAb) responses against batCoVs, SARS-CoV-1, SARS-CoV-2, and SARS-CoV-2 variants B.1.1.7, P.1, and B.1.351. Nanoparticle vaccination resulted in a SARS-CoV-2 reciprocal geometric mean neutralization ID50 titer of 47,216, and protection against SARS-CoV-2 in macaque upper and lower respiratory tracts. Importantly, nucleoside-modified mRNA encoding a stabilized transmembrane spike or monomeric RBD also induced SARS-CoV-1 and batCoV cross-nAbs, albeit at lower titers. These results demonstrate current mRNA vaccines may provide some protection from future zoonotic betaCoV outbreaks, and provide a platform for further development of pan-betaCoV vaccines.

Press release from Duke University: https://www.eurekalert.org/pub_releases/2021-05/dumc-nvb051021.php

 

[Ygggdrasil]

Novavax released data from its phase 3 trial of ~30k people in the US and Mexico, showing 90% effectiveness in preventing symptomatic infection. This effectiveness is in line with data released earlier from a smaller trial done in the UK and South Africa, and is similar to the effectiveness reported for the mRNA vaccines. Unlike the mRNA vaccines, which need to be stored and shipped frozen, the Novavax vaccine is a protein subunit vaccine that can be stored and shipped at normal refrigerator temperatures, which may make it easier to distribute. It's unlikely to help in the vaccination efforts in the US, but will likely be important for expanding vaccination efforts worldwide, especially in developing countries.

the vaccine did show effectiveness against the alpha variant (B.1.1.7), but because the trial was conducted in North America where the other variants are not as prevalent, the trial could not assess the effectiveness against the other variants (beta/B.1.351, gamma/P.1 or delta/B.1.617.2). Data from the earlier trial in South Africa suggested lower effectiveness of the vaccine in preventing symptomatic disease from the beta variant (B.1.351), though it was still highly effective at preventing severe disease, hospitalization and death.

The data have not yet been published in a peer-reviewed scientific journal and have only been released via press release from the company.

Novavax press release: https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-90-overall-efficacy-and

Popular press summary: https://www.statnews.com/2021/06/14/novavax-covid-19-vaccine-highly-effective-in-late-stage-trial/

 

[bhobba]

It's unlikely to help in the vaccination efforts in the US, but will likely be important for expanding vaccination efforts worldwide, especially in developing countries.

Thanks for the post. It is a significant milestone for Aus because we have ordered 51 million doses. Some in Aus have gone mad with the AZ vaccine and its 1 in a million death rate. They only want Pfizer. I wonder how they feel about its possible heart issue? Our stockpile of Pfizer is limited, and rationing has started in some places like Victoria (or so it is reported anyway):
https://www.dailymail.co.uk/news/article-9646627/Covid-Australia-Fears-Victoria-RUN-Pfizer-jabs.html

If we actually get our ordered Novavax, that possibly will be a big help.

Thanks
Bill

 

[Ygggdrasil]

One cautionary note is that Novavax has been having issues with manufacturing and its supply chain (one reason why its trials took much longer than the other vaccines). For example, see:

https://endpts.com/as-fears-mount-over-jj-and-astrazeneca-novavax-enters-a-shaky-spotlight/
https://www.theatlantic.com/science...cies-may-hold-key-coronavirus-vaccine/616792/

In the Stat News article I referenced above, the company says it expects to make 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year. Showing efficacy and safety in phase 3 trials is an important step towards getting the vaccine to people worldwide, but it is not the final step as now the company must work on scaling its manufacture and distribution capabilities. Hopefully, it can meet these goals.

 

[Vanadium 50]

Some in Aus have gone mad with the AZ vaccine and its 1 in a million death rate. They only want Pfizer.

Why is this a problem? Australia is a free country. Shouldn't people have a choice?

It may not even be irrational. There are, what, 30 million people in Australia? So it's up to 30 deaths from the AZ vaccine. When was the last Covid death? Six months ago? If you're under 75 or 80, it becomes even more rational. If you don't live in the cool and trendy (and infected) southeast of the country, it's even more rational.