SARS-CoV-2 vaccines

Anaxagoras · Post by **Anaxagoras** » Thu Dec 10, 2020 10:17 am

Pyrrho wrote: ↑Thu Dec 10, 2020 7:52 am Can't find a link--actually can't be arsed to find a link--but IIRC immunity from having had the virus lasts about 6 months.

Length of immunity from the vaccine remains to be seen although the data show that some people in the clinical trials who received the vaccine did get the virus anyway.

YMMV etc.

I believe it lasts at least 6 months. Could be much longer. There hasn't really been enough time to confirm yet whether it lasts for a year or more. But people who had the original SARS still have antibodies for it.

There was a study in Japan, and while I cannot seem to find the study itself, here's the Japan TImes' write-up:

Japan study finds 98% of COVID-19 patients had immunity six months later

A Japanese research team has detected antibodies that neutralized the virus that causes COVID-19 in 98% of people who had been sick with the disease in tests performed six months after they became infected.

The team, led by Yokohama City University professor Takeharu Yamanaka, said Wednesday it plans to conduct a follow-up survey to see whether the people will still have such antibodies a year after their infections.

In the latest survey, which was the largest of its type conducted in the country, the team checked blood samples from 376 people who had already recovered from COVID-19. The samples were collected six months after they were infected.

“In general, people with neutralizing antibodies are believed to carry a low risk of reinfection,” Yamanaka told a news conference.

“This gives some hope” in relation to the vaccines set to be released, with the study showing that immunity obtained through natural infection can last at least six months, according to Yamanaka.

He cautioned, however, that immunity acquired through natural infection is not necessarily the same as that obtained from a vaccine.

The study was conducted on individuals who expressed an interest in participating, mostly from Tokyo, Kanagawa and Osaka prefectures. The average age of the participants, with equal numbers of men and women, stood at 49.

Of the participants, 71% had mild symptoms, 19% moderate symptoms and 6% severe symptoms, while 4% showed no symptoms.

The neutralizing antibodies were detected in 97% of the participants who were asymptomatic or had mild symptoms and 100% of those who experienced moderate or severe symptoms. Antibodies tended to be stronger in those whose symptoms had been more severe.

In the study, the team used cells from monkeys genetically modified to easily catch a virus similar to the novel coronavirus. After injecting blood serum taken from the participants into the cells, the team examined whether infection of the cells was prevented.

Various types of antibodies are created inside human bodies in response to viral infections. Some antibodies do not prevent further infection.

Personally, I'm betting that if 98% still have antibodies after 6 months, it's a good bet that there will be long-term immunity in a solid majority of people.

Pyrrho · Post by **Pyrrho** » Thu Dec 10, 2020 2:24 pm

VRBPAC is live, intros are done, now in the FDA presentation.

Pyrrho · Post by **Pyrrho** » Thu Dec 10, 2020 2:37 pm

Presentations in PDF format are available. Pfizer/BioNTech presentations are among the "Non-FDA" items.

https://www.fda.gov/advisory-committees ... nouncement

robinson · Post by **robinson** » Thu Dec 10, 2020 3:31 pm

If this shot works, then next up is the common cold and the flu

Pyrrho · Post by **Pyrrho** » Thu Dec 10, 2020 4:20 pm

Article in The New England Journal of Medicine about the Pfizer/BioNTech vaccine:

https://www.nejm.org/doi/full/10.1056/N ... tured_home

Pyrrho · Post by **Pyrrho** » Thu Dec 10, 2020 5:31 pm

Ahahaha Sidney Wolf is up!

Pyrrho · Post by **Pyrrho** » Fri Dec 11, 2020 8:12 am

The committee voted to recommend the EUA. There were concerns about the low representations of Black and Latinx people in the clinical trials, and concerns about inflammatory reactions in young people.

VRBPAC will meet on Dec 17 to discuss the Moderna vaccine...I think... will check later.

Pyrrho · Post by **Pyrrho** » Tue Dec 15, 2020 1:37 am

Vaccine documents apparently obtained via hack:

https://www.reuters.com/article/us-ema- ... SKBN28P00E

Moderna Inc said on Monday it was informed by the European Medicines Agency (EMA) certain documents related to pre-submission talks of its COVID-19 vaccine candidate were unlawfully accessed in a cyberattack on the medicines regulator.

The EMA, which assesses medicines and vaccines for the European Union, said earlier this month that it had been targeted in a cyberattack, which also gave hackers access to documents related to the development of the Pfizer Inc and BioNTech COVID-19 vaccine.

Witness · Post by **Witness** » Tue Dec 15, 2020 1:44 am

Kizzmekia Corbett, an African American woman, is praised as key scientist behind COVID-19 vaccine

Dr. Anthony Fauci, the nation's top infectious disease expert and a constant presence on TV during the coronavirus pandemic, was asked a blunt question during a forum hosted last week by the National Urban League: "Can you talk about the input of African American scientists in the vaccine process?"

Fauci did not hesitate when giving his answer.

"The very vaccine that's one of the two that has absolutely exquisite levels -- 94 to 95% efficacy against clinical disease and almost 100% efficacy against serious disease that are shown to be clearly safe -- that vaccine was actually developed in my institute's vaccine research center by a team of scientists led by Dr. Barney Graham and his close colleague, Dr. Kizzmekia Corbett, or Kizzy Corbett," Fauci told the forum. "Kizzy is an African American scientist who is right at the forefront of the development of the vaccine."

https://abcnews.go.com/Health/kizzmekia ... d=74679965

Anaxagoras · Post by **Anaxagoras** » Tue Dec 15, 2020 4:05 am

Tracking vaccine distribution, state by state

Pyrrho · Post by **Pyrrho** » Tue Dec 15, 2020 1:18 pm

The FDA has posted meeting materials for the December 17 VRBPAC meeting that will discuss the Moderna vaccine:

https://www.fda.gov/advisory-committees ... -materials

Links to the briefing documents:

FDA
https://www.fda.gov/media/144434/download

Moderna
https://www.fda.gov/media/144452/download

https://www.fda.gov/media/144453/download

Pyrrho · Post by **Pyrrho** » Thu Dec 17, 2020 1:56 pm

Witness · Post by **Witness** » Sat Dec 19, 2020 2:22 am

FDA approves second Covid vaccine for emergency use as it clears Moderna's for U.S. distribution

Moderna's Covid-19 vaccine is the second approved for use in the U.S.

It will bolster the number of available doses, which states desperately need to fend off the pandemic.

The U.S. plans to distribute roughly 5.9 million doses of Moderna's vaccine to 64 states, territories and major cities across the nation next week.

https://www.cnbc.com/2020/12/18/moderna ... y-use.html

Employers can bar unvaccinated employees from the workplace, EEOC says

With the first doses of Pfizer's COVID-19 vaccine now being administered in the U.S., the federal government is giving employers around the country the green light to require immunization for most workers.

In general, companies have the legal right to mandate that employees get a COVID-19 shot, the Equal Employment Opportunity Commission (EEOC) said Wednesday. More specifically, employers are entitled — and required — to ensure a safe workplace in which "an individual shall not pose a direct threat to the health or safety of individuals in the workplace." That can mean a company requiring its workforce to be vaccinated.

The Americans with Disabilities Act limits an employer's ability to require workers to get a medical examination. But the EEOC's latest guidance clarifies that getting vaccinated does not constitute a medical exam. As a result, ordering employees to get a COVID-19 shot would not violate the ADA.

https://www.cbsnews.com/news/covid-19-v ... d-workers/

The anti-vaxxers will howl.

Pyrrho · Post by **Pyrrho** » Sat Dec 19, 2020 12:53 pm

That should be a matter between a person and their doctor, not a government edict.

Pyrrho · Post by **Pyrrho** » Mon Dec 28, 2020 9:47 pm

Novavax vaccine enters Phase 3:

https://apnews.com/article/public-healt ... 62209e6f36

https://ir.novavax.com/news-releases/ne ... 3-efficacy

Witness · Post by **Witness** » Tue Dec 29, 2020 2:20 am

Pyrrho wrote: ↑Sat Dec 19, 2020 12:53 pm That should be a matter between a person and their doctor, not a government edict.

That's not how I read it: it's between employer and employees.

Anaxagoras · Post by **Anaxagoras** » Tue Dec 29, 2020 7:54 am

This vaccine tracker from Bloomberg shows how many people have been vaccinated in real time. Supposedly gets updated multiple times per day:

https://www.bloomberg.com/graphics/covi ... tribution/

The biggest vaccination campaign in history has begun. More than 4.6 million doses in 16 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 2.13 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.

US officials had been aiming to give 20 million doses by the end of 2020, but obviously that's not going to happen.

Let's say, to pick a round number, that the goal is to vaccinate 200 million Americans (61% of the total, or 328 million). Since it requires 2 doses, that's 400 million, so we're still at only about half a percent.

If we count people who have already had the disease and recovered as being immune already and not needing a vaccine, that number is 11 million so far. But they seem to be giving those people the vaccine anyway, even though they probably don't need it.

Here's an alternative tracker:

https://ourworldindata.org/covid-vaccinations

You can compare different countries. So far, Israel seems to have made the most progress, at 4.37 doses per 100 people, followed by Bahrain at 3.23, UK at 1.18 and USA at 0.64. Russia, meanwhile, which claimed to have it's "Sputnik V" vaccine ready before anyone else is still only at 0.04. So it seems like more of a propaganda announcement because the actual doses given remain very small, and their manufacturing capacity seems to be rather limited.

There's some information in this New York Times article too, about how many vaccines have actually been received by states so far. It seems that most of the doses received have not actually been administered yet, for some reason.

The federal government said Monday that it has delivered more than 11.4 million doses to states, territories and federal agencies.

11.4 million doses received, but only 2.1 million actually administered so far. Why? Could it be that they are having trouble getting them to the people with the highest priority to receive them first? I really hope they pick up the pace because at this rate (call it about 1 million doses per week) it would take years to vaccinate a majority of the population.

Pyrrho · Post by **Pyrrho** » Tue Dec 29, 2020 11:53 am

It is a logistics problem. For one thing, it's not simple to deliver a vaccine that requires special temperatures, such as the Pfizer/BioNTech vaccine. The freezer equipment is not all that common.

The Moderna vaccine is a bit easier to store.

The Atheist · Post by **The Atheist** » Tue Dec 29, 2020 11:01 pm

Witness wrote: ↑Sat Dec 19, 2020 2:22 amEmployers can bar unvaccinated employees from the workplace, EEOC says

I believe that's exactly as it should be. We're lucky here that the work safety regulations mean employers could be held liable is they don't mandate vaccinations. I'd like to see schools require vaccinations as well.

Witness · Post by **Witness** » Wed Dec 30, 2020 1:57 am

Some more about what Anax posted:

U.S. likely to fall short of goal to vaccinate 20 million people against Covid before end of year

With only a few days left before the new year, the United States will likely fall short of its goal to vaccinate 20 million Americans by the end of 2020.

The Centers for Disease Control and Prevention said just more than 11.4 million doses had been distributed but only about 2.1 million had been administered as of the latest figures released Monday.

The CDC cited data reporting lags and the pending launch of the federal government's partnership with pharmacy chains as reasons for the gap between delivered and administered doses.

https://www.cnbc.com/2020/12/29/us-to-f ... s-end.html

Anaxagoras · Post by **Anaxagoras** » Wed Dec 30, 2020 6:34 am

https://www.statnews.com/2020/12/29/pub ... e-rollout/

He pledged to “move heaven and earth to get us going in the right direction,” and foreshadowed a number of policy efforts he’s likely to take in his first 100 days in office, including using the Defense Production Act to speed vaccine manufacturing, setting up a public health awareness campaign, and sending mobile vaccination units to hard-to-reach communities. Biden also reiterated his previous pledge to make sure 100 million doses of the Covid-19 vaccines are administered in his first 100 days in office.

So Biden is promising 100 million doses in 100 days. That's still just 1 million per day and remember that it takes 2 doses per person. At that rate it would take almost 2 years to vaccinate everyone in the United States.

Pyrrho · Post by **Pyrrho** » Wed Dec 30, 2020 12:01 pm

It is a daunting logistics problem that cannot be overcome by means of promises.

Anaxagoras · Post by **Anaxagoras** » Thu Dec 31, 2020 2:14 am

Anaxagoras wrote: ↑Tue Dec 29, 2020 7:54 am This vaccine tracker from Bloomberg shows how many people have been vaccinated in real time. Supposedly gets updated multiple times per day:

https://www.bloomberg.com/graphics/covi ... tribution/

Currently stands at 2.67 million for the US and 5.6 million worldwide. That's up about 0.54 million and 1 million respectively from the last time I checked, which was about 42 hours ago.

Hopefully the pace will pick up next month. I imagine it does take time to ramp up to full production. And the distribution is tricky too.

Witness · Post by **Witness** » Thu Dec 31, 2020 2:40 am

Anaxagoras · Post by **Anaxagoras** » Thu Dec 31, 2020 4:01 am

Shots are slow to reach arms as Trump administration leaves final steps of mass vaccination to beleaguered states

In suburban Milwaukee, clinicians recently discarded 500 doses of coronavirus vaccine after vials were left unrefrigerated. In southeastern Arizona, a rural clinic has enough shots but too few employees lining up to take them. And on the coast of Maine, physicians have been left in the dark about when they will get vaccinated.

Great. So there are people who are prioritized to receive shots who don't want them. Let those of us who do want to get vaccinated have the vaccines if people don't want them.

Doctor X · Post by **Doctor X** » Thu Dec 31, 2020 4:35 am

Cannot help fools.

– J.D.

Pyrrho · Post by **Pyrrho** » Thu Dec 31, 2020 12:15 pm

In Ohio, 60% of nursing home staff have so far refused vaccination.

Anaxagoras · Post by **Anaxagoras** » Thu Dec 31, 2020 1:13 pm

If you work at a nursing home it really should be mandatory. Unless you have a history of anaphylactic reactions or some special legitimate medical reason.

Witness · Post by **Witness** » Thu Dec 31, 2020 11:14 pm

U.S. Department of Defense Awards Moderna $1.97 Billion COVID-19 Vaccine Contract

The U.S. United States Department of Defense (DOD) awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine. The manufacturing will be handled in Cambridge, Massachusetts and is expected to be fulfilled by June 30, 2021.

Moderna’s vaccine has been granted emergency use authorization (EUA) in the U.S. and in Canada. The EUA was granted by the FDA on December 18 for individuals 18 years of age and older. Health Canada granted authorization on December 23. The Canadian authorization came under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and was based on a rolling review of data that started on October 12. It included data from the Phase III COVE trial of 30,000 volunteers.

Earlier in December, the Canadian government exercised its option to increase its confirmed order of the vaccine by 20 million doses, bringing the total commitment to 40 million doses.

https://www.biospace.com/article/u-s-de ... -contract/

Anaxagoras · Post by **Anaxagoras** » Fri Jan 01, 2021 6:24 am

Well, it appears we have our first case of deliberate sabotage. Those 500 spoiled doses mentioned in the article above? Not an accident.

Employee intentionally removed COVID-19 vaccine from fridge, ruining more than 500 doses, hospital says; FBI investigating

MILWAUKEE — Advocate Aurora Health says a now-fired employee intentionally removed 57 vials of the Moderna coronavirus vaccine from a refrigerator last weekend, causing them to become ineffective and be discarded.

Each vial contains enough vaccine for 10 vaccinations.

Initially, Aurora was "led to believe" the removal was an error. But Wednesday, the employee "acknowledged that they intentionally removed the vaccine from refrigeration," according to a statement from the health care provider.

Grafton Police Department said in a statement late Wednesday that it was notified by Aurora shortly after 6 p.m. "regarding an employee tampering with vials of the COVID-19 vaccine" at its hospital.

The statement goes on to say the incident is being investigated by the FBI and the Food and Drug Administration as well as Grafton police.

Aurora said the action by the employee is "a violation of our core values."

The employee was fired, and Aurora said it notified "appropriate authorities for further investigation."

Aurora said no other employees were involved and that it plans to release more information on Thursday.

Anaxagoras · Post by **Anaxagoras** » Fri Jan 01, 2021 6:53 am

Meanwhile, Israel now has vaccinated over 9% of its population. They are far ahead of any other country. Not in absolute numbers but per capita. Their population is around 9 million.

https://ourworldindata.org/covid-vaccinations

Israel nears one million coronavirus vaccinations (Jerusalem Post)

Israel is expected to have over a million citizens vaccinated by the end of Friday, after over 153,000 Israelis received the coronavirus vaccine in Israel on Thursday, bringing the total number of vaccinations administered to 950,000, the Health Ministry announced on Friday morning.

"So how are Israel's 950,000 vaccinated citizens? Just yesterday we broke another record and vaccinated 153,430 people at 325 vaccination stations across the country. Today we will pass the [milestone of a] million vaccinated," said Health Minister Yuli Edelstein. "On behalf of all of you, I thank the medical staff for the amazing work."

Anaxagoras · Post by **Anaxagoras** » Fri Jan 01, 2021 10:57 am

Warp Speed chief: U.S. won’t get AstraZeneca vaccine until April

Americans likely won’t receive AstraZeneca's coronavirus vaccine before April because of lingering questions about its effectiveness in certain groups, a top Trump administration health official said hours after U.K. regulators authorized the company’s shot Wednesday.

The prediction by Moncef Slaoui, head of Operation Warp Speed, moves back the U.S. government’s timeline for greenlighting the AstraZeneca shot by at least two months. Slaoui earlier this month estimated the British drugmaker would file for emergency use authorization with the Food and Drug Administration as early as February.

“We project, if everything goes well, that the readout and emergency use authorization may be granted somewhere early in the month of April,” Slaoui said on a press call Wednesday.

Slaoui said that while the AstraZeneca vaccine appears very effective against severe disease, its efficacy among elderly people is “effectively unknown” because few older people were enrolled early in the trial. He said that remains his biggest question about the company’s shot, given the virus’ impact on elderly people.

The UK thinks it's OK to use it already, but apparently the US government (or at least this guy) is taking a different view.

Is there any reason to think it might not work as well in older people given that trials mostly involved younger people?

Could it be nationalism? The AstraZeneca vaccine is the so-called Oxford vaccine, isn't it? Why has only the UK approved it, and conversely, is Operation Warp Speed trying stave off the competition to benefit Pfizer and Moderna?

ETA: or even more troubling, this guy is probably going to leave his position in January when Biden takes over. Is he going to parachute into a lucrative position at Pfizer or Moderna?

Pyrrho · Post by **Pyrrho** » Fri Jan 01, 2021 1:28 pm

I have read that there are important questions about how the AstraZeneca clinical trials were conducted and how the data were gathered.

Let's see what the FDA says about it. No doubt there will be an advisory committee meeting devoted to it.

eta: Oh yeah, here it is:

viewtopic.php?f=5&t=49841&p=1045070&hil ... a#p1045070

Some other discussion in that thread.

Pyrrho · Post by **Pyrrho** » Sat Jan 02, 2021 12:37 pm

Peer reviews of Pfizer/BioNTech vaccine results and the Moderna vaccine results.

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

https://www.nejm.org/doi/full/10.1056/NEJMoa2035389

Witness · Post by **Witness** » Sat Jan 02, 2021 11:06 pm

240 Israelis found with COVID after vaccination, underscoring need for vigilance

Pfizer’s shot only begins having an effect 8-10 days after first injection, and only reaches full potential after the second dose

Among the nearly one million Israelis vaccinated against coronavirus so far, some 240 Israelis have been diagnosed with the virus days after getting the shot, Channel 13 News reported Thursday.

The figure underscores the need for individuals to continue to protect themselves for weeks after being inoculated, as the body takes time to develop effective antibodies against the SARS-CoV-2 virus, which causes COVID-19.

The Pfizer vaccine is not made with the coronavirus itself, meaning that there is no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus and create antibodies to attack if it encounters the real thing.

But this process takes time, and studies of the vaccine so far have shown immunity to the virus rises only some 8-10 days after the first injection — and then only to around 50 percent effectiveness.

This is why the second dose of the vaccine, given 21 days after the first, is critical: It strengthens the immune system’s response to the virus, bringing it to 95% effectiveness and ensuring that immunity lasts. This level of immunity is only reached about a week after the second dose — or 28 days after the first.

Anyone who is infected a few days before getting the vaccine’s first dose or in the weeks before full effectiveness is reached is still in danger of developing symptoms. (Even when the vaccine reaches its top potential, there remains a 5% chance of this.)

https://www.timesofisrael.com/240-israe ... vigilance/

You've been warned.

Anaxagoras · Post by **Anaxagoras** » Mon Jan 04, 2021 2:32 pm

I think it's well known that you don't get immunity immediately. Or at least it should be. Even in the clinical trials, there were people who got sick within a 10-day period after getting the first shot. After that, compared to the placebo group, it went down considerably.

Israel is vaccinating so fast it’s running out of vaccine (Washington Post)

Jan. 4, 2021 at 10:20 p.m. GMT+9
JERUSALEM — Israel, which has inoculated a higher proportion of its population against the coronavirus than any other country, is delivering shots so quickly that it is outstripping its supply of vaccine.
Health officials are scrambling to buy more doses and said they may pause giving the first round of shots to younger citizens to deliver the second, final injections to the elderly.
The situation is essentially the opposite of that in many parts of the United States, where vaccines are sitting unused as mass inoculation programs struggle to build momentum.

That's frustrating. For some reason, the US has vaccines available and unused, but shots are not getting into arms like they are in Israel.
Israel seems to have no trouble getting what shots they do have into arms.

And Japan hasn't even approved it yet. Incidentally, it looks like Japan will have another emergency declaration (at least in Tokyo and the 3 adjacent prefectures), which is what they did to slow the spread last spring, and it seemed to work at the time. At a high cost to be sure, but it slowed the spread and it stayed at a fairly low level for the rest of the summer, and then started to grow again as the weather turned colder. The situation objectively is not as dire here as it is in the United States and some other countries I suppose, in terms of the number of infections and deaths, but numbers are rising rapidly.

Pyrrho · Post by **Pyrrho** » Mon Jan 04, 2021 3:40 pm

There are significant logistics problems in the US, coupled with an administration that does not appear give a damn.

DJ · Post by DJ » Mon Jan 04, 2021 4:50 pm

I think a bureaucracy sitting on its thumbs during a transition is more on point.

Pyrrho · Post by **Pyrrho** » Mon Jan 04, 2021 5:02 pm

They've had their thumbs up their asses the entire year. Now they're about to start cutting vaccine doses in half because they failed to ramp up logistics, leaving it to the states to figure out for the most part.

DJ · Post by DJ » Mon Jan 04, 2021 5:40 pm

Federalism, love it or hate it.