Pfizer’s CEO, Albert Bourla, said the vaccine was still offering strong protection at the six-month mark and “indicators right now … are telling us that there is a protection against the transmission of the disease.
Bourla said current data shows that after six months the protection is robust. "But there are a lot of indicators right now that are telling us that there is a protection against the transmission of the disease," Bourla added.
Ugur Sahin of BioNTech (which developed the vaccine for Pfizer) said the EU could see herd immunity by July or August 2021
Europe can achieve herd immunity against the coronavirus this summer, the head of the German pharmaceutical company BioNTech, said on Wednesday. "Europe will reach herd immunity in July, latest by August,'' Ugur Sahin, BioNTech's chief executive, told reporters. While the precise threshold required to reach that level of immunization is still under debate, experts say a level above 70% would significantly disrupt transmission of the virus within a population.
"To eliminate COVID-19 anywhere, we need to eliminate it everywhere" - JT
Justin Trudeau @JustinTrudeau Officiel du gouvernement - Canada To eliminate COVID-19 anywhere, we need to eliminate it everywhere. I’ve said those words before and, during today’s working session at the @G7, we focused on how we can do that - and on how, together, we can make sure no one gets left behind as we recover.
Inhibition of the replication of SARS-CoV-2 in human cells by the FDA-approved drug chlorpromazine
Urgent action is needed to fight the ongoing COVID-19 pandemic by reducing the number of infected people along with the infection contagiousness and severity. Chlorpromazine (CPZ), the prototype of typical antipsychotics from the phenothiazine group, is known to inhibit clathrin-mediated endocytosis and acts as an antiviral, in particular against SARS-CoV-1 and MERS-CoV. In this study, we describe the in vitro testing of CPZ against a SARS-CoV-2 isolate in monkey and human cells. We evidenced an antiviral activity against SARS-CoV-2 with an IC50 of ∼10μM. Because of its high biodistribution in lung, saliva and brain, such IC50 measured in vitro may translate to CPZ dosage used in clinical routine. This extrapolation is in line with our observations of a higher prevalence of symptomatic and severe forms of COVID-19 infections among health care professionals compared to patients in psychiatric wards. These preclinical findings support the repurposing of CPZ, a largely used drug with mild side effects, in COVID-19 treatment.
Association between antidepressant use and reduced risk of intubation or death in hospitalized patients with COVID-19
We examined the potential usefulness of antidepressant use in patients hospitalized for COVID-19 in an observational multicenter retrospective cohort study conducted at AP-HP Greater Paris University hospitals.
The serotonin reuptake inhibitor Fluoxetine inhibits SARS-CoV-2
To circumvent time-consuming clinical trials, testing whether existing drugs are effective inhibitors of SARS-CoV-2, has led to the discovery of Remdesivir. We decided to follow this path and screened approved medications “off-label” against SARS-CoV-2. In these screenings, Fluoxetine inhibited SARS-CoV-2 at a concentration of 0.8µg/ml significantly, and the EC50 was determined with 387ng/ml. Fluoxetine is a racemate consisting of both stereoisomers, while the S-form is the dominant serotonin reuptake inhibitor. We found that both isomers show similar activity on the virus. Fluoxetine treatment resulted in a decrease in viral protein expression. Furthermore, Fluoxetine inhibited neither Rabies virus, human respiratory syncytial virus replication nor the Human Herpesvirus 8 or Herpes simplex virus type 1 gene expression, indicating that it acts virus-specific. We see the role of Fluoxetine in the early treatment of SARS-CoV-2 infected patients of risk groups.
Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19
In this randomized trial that included 152 adult outpatients with confirmed COVID-19 and symptom onset within 7 days, clinical deterioration occurred in 0 patients treated with fluvoxamine vs 6 (8.3%) patients treated with placebo over 15 days, a difference that was statistically significant.
Preventing death and improving health outcomes for all people affected by COVID-19.
The TOGETHER Trial represents an international collaboration of diverse partners committed to preventing death and improving health outcomes for all people affected by COVID-19. Watch this brief video to better understand the important and innovative work that we are engaged in.
Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial
Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital.
All but one monoclonal antibody treatments fail against omicron.
Treatments Fail Against Omicron The single remaining monoclonal antibody therapy effective against the variant is now in short supply in the U.S., imperiling an option that doctors and hospitals have relied on.
Dozens of re-purposed drugs for COVID
List of a number of therapeutic agents and how the evidence stacks up for or agaist their use in treating COVID-19.
that's partly why all the variants are arising now, because mRNA shots only have the spike epitopes in there
must say that early in the outbreak last year, when the vaccine development was just ramping up, we talked a lot about this idea that, should they really only be focusing on spike? Shouldn't they be putting some other viral proteins on, and in retrospect it was a good decision to get vaccines out in less than a year, because otherwise it might've been more complicated. But that's partly why all the variants are arising now, because we have only the spike epitopes in there. And so it's easy for the virus to get around that. So, it's two ways, that story. So those are the things that we've talked about. And also, I should say, we talked a long time about antivirals and whether they would play a role. And, we looked at remdesivir and how it was given so late in infection. And we said, this is not gonna work, it's too late. That's an inflammatory disease, later in infection. And it turned out remdesivir, yes, it doesn't work if you give it in the inflammatory phase. And now we actually don't have any useful antivirals, and the monoclonals can be effective, but again, you can't give them when someone's in an ICU, you have to hit them before. And we've just learned that. And these are some of the things we've talked about over the months. Makary: Interesting. You know, I'm really interested in what you said about whether or not the spike protein was the right thing to target in the vaccines -- and it turns out it was very effective. Because I was having this conversation with one of my colleagues who does a lot of immunology research. And I asked the question -- I like to put big questions out there to have a discussion -- and the question was, do you think natural immunity or vaccinated immunity is stronger, and which one's more durable, two different domains. And I'd love your thoughts on that. But one interesting thing he said was he thought that maybe natural immunity, if you really get sick and you've got to mount a big antibody response, may be better because your body is developing antibodies and memory to all of the surface of the virus, not just the spike protein, and that may be better immune protection. Racaniello: I think it's an interesting question and there's no one answer because every virus is slightly different. For example, the human papillomavirus, the vaccines we have make amazing immunity, better than immunity you get from natural infection, because there's so much protein in those vaccines. And you end up having great mucosal immunity, which is what you need there. On the other hand, other vaccines allow infection without disease. Of course, the polio vaccines were only tested to prevent polio, not to prevent infection. That's all we cared about. Now for SARS-CoV-2, yes, having other proteins in the mix is a good idea. I think it depends on the severity of the disease. We did a paper 6 months ago which studied people who had died from COVID. So this was a very serious disease. And their lymph nodes had no germinal centers, which means no memory B cells to SARS-CoV-2. Even though they had antibodies, they had very low affinity antibodies. And so the outcome of that was the idea that if you have a very serious disease, then you're not likely to have a long memory response. Now, those are people who died. So we don't know how it applies to people who have lived because they were able to take out their lymph nodes and study them. And it's not so easy to do in people who have survived. So a natural infection can have consequences. So, on the one hand, yes, you make a lot of viral proteins and those are great epitopes for mainly T cells because I think most of the antibodies that are going to block infection are going to be spike directed. But any other viral protein could in theory be a T-cell target. So you'll get more epitopes. The counter view is that the virus may encode immune antagonists that could alter the immune response in some way that's not as good as, say, a vaccine. So it really depends. And we don't know enough yet. So I think if people are making a blanket statement that natural infection is always better, that's not always correct. It really depends on the virus.
Physician-scientist Eric Topol, head of Scripps Labs, said these vaccines “will go down in history as one of science and medical research’s greatest achievements.”
This will go down in history as one of science and medical research's greatest achievements. Perhaps the most impressive.
The FDA had originally said it would not approve a vaccine less than 50-per-cent effective.
The FDA's cutoff for Covid-19 vaccine effectiveness is 50 percent. What does that mean? No vaccine is 100 percent effective, but some work better than others.
A Mayo clinic study showed that after six months, protection granted by the two Pfizer doses dropped from the original 95 per cent to 42 per cent.
Although clinical trials and real-world studies have affirmed the effectiveness and safety of the FDA-authorized COVID-19 vaccines...
Another Israeli study showed vaccine protection had dropped to 16 per cent.
Israeli lawmakers are keen to avoid another lockdown after overseeing one of the world's fastest vaccination drives. New daily coronavirus infections, however, have just climbed to record levels.
protection was already fading at five months for the earlier variants
And a graph of higher rates of breakthrough over time in Israel
The Pfizer study followed about 38,000 people without COVID
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Will covid-19 vaccines save lives? Current trials aren’t designed to tell us - most people with symptomatic COVID-19 experience only mild symptoms
As phase III trials of covid-19 vaccines reach their target enrolments, officials have been trying to project calm. The US coronavirus czar Anthony Fauci and the Food and Drug Administration leadership have offered public assurances that established procedures will be followed.1234 Only a “safe and effective” vaccine will be approved, they say, and nine vaccine manufacturers issued a rare joint statement pledging not to prematurely seek regulatory review.5 But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.6 Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7 Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus
Moderna vaccine only studied for two months before release
Vaccines and Related Biological Products Advisory Committee Meeting December 17, 2020 FDA Briefing Document Moderna COVID-19 Vaccine
Pfizer vaccine only studied for two months before release
Israel’s head of public health services, said the summer’s rise in the number of hospitalized patients who had been fully vaccinated with Pfizer’s vaccine was “scary.”
Dr. Sharon Alroy-Preis, Israel’s head of public health services, said the summer’s rise in the number of hospitalized patients who had been fully vaccinated with Pfizer’s vaccine was “scary.” She said 60 percent of severely or critically ill patients and 45 percent of those who died during what she called the fourth surge had received two injections of Pfizer’s vaccine. After offering boosters to the general population, she said, Israel was now averaging about half as many severe or critically ill patients as anticipated.
"45 per cent of the people who died in the fourth wave were doubly vaccinated"
ADVISORY COMMITTEE MEETING Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement SEPTEMBER 17, 2021
"global herd immunity, once promoted as a singular solution, is unreachable. Rather than die out, the virus will likely ping-pong back and forth across the globe for years to come.
It is time to say it out loud: the virus behind the COVID-19 pandemic is not going away. SARS-CoV-2 cannot be eradicated, since it is already growing in more than a dozen different animal species. Among humans, global herd immunity, once promoted as a singular solution, is unreachable. Most countries simply don’t have enough vaccines to go around, and even in the lucky few with an ample supply, too many people are refusing to get the shot. As a result, the world will not reach the point where enough people are immune to stop the virus’s spread before the emergence of dangerous variants—ones that are more transmissible, vaccine resistant, and even able to evade current diagnostic tests. Such supervariants could bring the world back to square one. It might be 2020 all over again. Rather than die out, the virus will likely ping-pong back and forth across the globe for years to come. Some of yesterday’s success stories are now vulnerable to serious outbreaks. Many of these are places that kept the pandemic at bay through tight border controls and excellent testing, tracing, and isolation but have been unable to acquire good vaccines. Witness Taiwan and Vietnam, which experienced impressively few deaths until May 2021, when, owing to a lack of vaccination, they faced a reversal of fortune. But even countries that have vaccinated large proportions of their populations will be vulnerable to outbreaks caused by certain variants. That is what appears to have happened in several hot spots in Chile, Mongolia, the Seychelles, and the United Kingdom. The virus is here to stay. The question is, What do we need to do to ensure that we are, too?
CDC director Rochelle Walensky told CNN vaccines do not prevent transmission.
“Our vaccines are working exceptionally well. They continue to work well for Delta; with regard to severe illness and death, they prevent it. But what they can’t do any more is prevent transmission.” (Note: they never ever did prevent infection and transmission - RJS)
coronaviruses do not tend to trigger long-lasting immunity
A chief concern is that coronaviruses do not tend to trigger long-lasting immunity. About a quarter of common colds are caused by human coronaviruses, but the immune response fades so rapidly that people can become reinfected the next year. Researchers at Oxford University recently analysed blood from recovered Covid-19 patients and found that levels of IgG antibodies – those responsible for longer-lasting immunity – rose steeply in the first month of infection but then began to fall again. Last week, scientists at Rockefeller University in New York found that most people who recovered from Covid-19 without going into hospital did not make many killer antibodies against the virus. “That’s what is particularly challenging,” says Stanley Perlman, a veteran coronavirus researcher at the University of Iowa. “If the natural infection doesn’t give you that much immunity except when it’s a severe infection, what will a vaccine do? It could be better, but we don’t know.” If a vaccine only protects for a year, the virus will be with us for some time. Another challenge: making any vaccine safe In the rush to develop a vaccine – there are now more than 100 in development – safety must remain a priority. Unlike experimental drugs for the severely ill, the vaccine will be given to potentially billions of generally healthy people. This means scientists will have to check extremely carefully for signs of dangerous side-effects. During the search for a Sars vaccine in 2004, scientists found that one candidate caused hepatitis in ferrets. Another serious concern is “antibody-induced enhancement” where the antibodies produced by a vaccine actually make future infections worse. The effect caused serious lung damage in animals given experimental vaccines for both Sars and Mers. Hopes for eliminating the virus start with a vaccine but do not end there. “If and when we have a vaccine, what you get is not rainbows and unicorns,” says Larry Brilliant, CEO of Pandefense Advisory, who worked on the WHO’s smallpox eradication programme. “If we are forced to choose a vaccine that gives only one year of protection, then we are doomed to have Covid become endemic, an infection that is always with us.” The virus will still be tough to conquer with a vaccine that lasts for years. “It will be harder to get rid of Covid than smallpox,” says Brilliant. With smallpox it was at least clear who was infected, whereas people with coronavirus can spread it without knowing. A thornier problem is that as long as the infection rages in one country, all other nations are at risk.
the original randomized clinical trials for Pfizer and Moderna did not test if the vaccines stop transmission
The New York Times ran several articles on this, reporting that AstraZeneca, Pfizer, and Moderna had each withheld their study protocols from outside scientists and the public. Withholding protocols guarantees that outside researchers can’t know how participants are selected or monitored, and how effectiveness or safety are defined, so they can’t really know what exactly is being studied.
“clinicians and public health practitioners should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons.”
A total of 978 specimens were provided by 95 participants, of whom 78 (82%) were fully vaccinated and 17 (18%) were not fully vaccinated. No significant differences were detected in duration of RT-PCR positivity among fully vaccinated participants (median: 13 days) versus those not fully vaccinated (median: 13 days; p=0.50), or in duration of culture positivity (medians: 5 days and 5 days; p=0.29). Among fully vaccinated participants, overall duration of culture positivity was shorter among Moderna vaccine recipients versus Pfizer (p=0.048) or Janssen (p=0.003) vaccine recipients. As this field continues to develop, clinicians and public health practitioners should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons. These findings are critically important, especially in congregate settings where viral transmission can lead to large outbreaks.
"lower probability of infectious virus detection in respiratory samples of vaccinated HCWs with breakthrough infections compared to unvaccinated HCWs with primary SARS-CoV-2 infections."
Background SARS-CoV-2 vaccines are highly effective at preventing COVID-19-related morbidity and mortality. As no vaccine is 100% effective, breakthrough infections are expected to occur. Methods We analyzed the virological characteristics of 161 vaccine breakthrough infections in a population of 24,706 vaccinated healthcare workers (HCWs), using RT-PCR and virus culture. Results The delta variant (B.1.617.2) was identified in the majority of cases. Despite similar Ct-values, we demonstrate lower probability of infectious virus detection in respiratory samples of vaccinated HCWs with breakthrough infections compared to unvaccinated HCWs with primary SARS-CoV-2 infections. Nevertheless, infectious virus was found in 68.6% of breakthrough infections and Ct-values decreased throughout the first 3 days of illness. Conclusions We conclude that rare vaccine breakthrough infections occur, but infectious virus shedding is reduced in these cases.
“we don’t see virtually any difference … between people vaccinated and nonvaccinated,” adding “both get infected with the virus, more or less at the same pace.”
Israeli vaccine advisor: “We have made mistakes” Professor Cyrille Cohen talks herd immunity and his pandemic regrets Cohen is head of Immunology at Bar Ilan University and a member of the advisory committee for vaccines for the Israeli Government. In a wide-ranging and forthright interview, the Professor tells Freddie Sayers: The Green Pass / vaccine passport concept is no longer relevant in the Omicron era and should be phased out. He and his colleagues were surprised and disappointed that the vaccines did not prevent transmission, as they had originally hoped. The biggest mistake of the pandemic in Israel was closing schools and education Omicron has accelerated the pandemic into the endemic phase, in which Covid will be “like flu” Especially with Omicron, where we don’t see virtually any difference, there is a very narrow gap between people vaccinated and non-vaccinated, both can get infected with a virus, more or less at the same pace. - CYRILLE COHEN, UNHERDTV
it is likely a highly significant majority of the unvaccinated now have natural immunity
INFECTIOUS DISEASE Feb. 09 2021 Active COVID Cases May Be Ten Times Official Count: Study The number of active COVID-19 cases in the United States is roughly ten times higher than the number of confirmed cases on any given day, according to a computer model by Columbia University Mailman School of Public Health scientists. Since the start of the pandemic, an estimated one-third of the U.S. population has already been infected, with numbers five times that of the official count. Jeffrey Shaman, PhD, a professor of environmental health sciences known for his COVID-19 projections, led the research, based on case numbers and anonymized cellphone location data to estimate population mixing. The findings appear ahead of peer review in a report by NPR. At the worst day of the pandemic so far, on January 2, 91 out of every 100,000 people in the U.S. tested positive. In fact, 998 per 100,000 people were actively shedding the virus on that day, according to the study’s estimates. In some areas, this discrepancy was even more profound: In Los Angeles, at the peak of the winter surge, 3 percent of the county’s population was infectious, or roughly 3,000 per 100,000.
mandating vaccines for the naturally immune “actually creates problems because when people see that they are forced to take a vaccine that they don’t need because they already are immune, that causes a lot of distrust in public health
“If we want to have long-term trust in public health, we cannot use coercion and mandates. We have to use education and mutual trust.”
Israel’s third booster helped beat back the Delta wave.
TEL AVIV, Israel - Israel, which last summer was the first country to offer wide-scale coronavirus booster shots, announced this week that it will roll out a fourth-dose campaign, again offering other nations a potential glimpse into their pandemic future as the omicron variant spreads across the globe.
Most of the World’s Vaccines Likely Won’t Prevent Infection From Omicron
A growing body of preliminary research suggests the Covid vaccines used in most of the world offer almost no defense against becoming infected by the highly contagious Omicron variant. All vaccines still seem to provide a significant degree of protection against serious illness from Omicron, which is the most crucial goal. But only the Pfizer and Moderna shots, when reinforced by a booster, appear to have initial success at stopping infections, and these vaccines are unavailable in most of the world. The other shots — including those from AstraZeneca, Johnson & Johnson and vaccines manufactured in China and Russia — do little to nothing to stop the spread of Omicron, early research shows. And because most countries have built their inoculation programs around these vaccines, the gap could have a profound impact on the course of the pandemic.
two doses, over time, fell to zero efficacy against Omicron
6657 test positive cases (44% delta, 56% omicron) were included. The 2-dose VE against omicron infection was 30.4% (95% CI, 5.0%-49.0%) at 14-90 days after vaccination and declined quickly thereafter. The 3-dose VE was 95.2% (93.4%-96.4%) against delta infection and 62.5% (56.2%-67.9%) against omicron infection. The 3-dose VE against omicron infection was low among immunocompromised individuals (11.5%; 0.0%-66.5%). None of the cases (delta or omicron) vaccinated with 3 doses were hospitalized compared to 53 delta and 2 omicron unvaccinated cases.
Danish data showed that a booster offered protection against severe disease, but “only to those over 70 years.”
Though 2 & 3 doses of vax not effectively preventing infection, 2 doses evidently protecting against severe disease & death in adults & 3 doses seem to offer extra protection in those >70
The U.K. Health Security Agency study showed the protection from the Pfizer booster (third shot) had dropped to 45-per-cent coverage at only 10 weeks.
SARS-CoV-2 variants of concern and variants under investigation in England Technical briefing 33 23 December 2021(PDF)
“There could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines [like the AstraZeneca or Johnson & Johnson]). If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines.
If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.
Dr. Gruber and Dr. Krause quit the FDA because the Biden administration was putting pressure on them to approve boosters before the vaccine committee had even met
Two Top F.D.A. Vaccine Regulators Are Set to Depart During a Crucial Period The announcement that Dr. Marion Gruber and Dr. Philip Krause will leave this fall comes as the agency conducts sensitive reviews of coronavirus vaccines for children and booster shots.
In December, the FDA and CDC leadership three times took the extraordinary step of not convening those experts for key booster meetings, in essence going around them because committee members had warned that the science supporting boosters for younger people was weak to non-existent, and they had safety concerns.
The Biden administration has been sidelining vaccine experts The FDA, for example, approved booster shots for 16- and 17-year-olds without convening a key advisory panel
Dr. Paul Offit, perhaps the most high profile provaccine physician-scientist in America, who was on the FDA panel told The Atlantic, he wouldn’t advise a booster for his healthy son in his 20s, or a healthy male in his teens, because the risks of myocarditis (higher in males) outweigh the benefits. Dr. Offit rejects the CDC’s and FDA’s all-or-nothing approach to children’s vaccination.
Should Teen Boys Get Boosted? Third shots for adolescent boys and young men were already a hard sell. Then came Omicron.
“Two doses of vaccine does nothing or almost nothing to stop symptomatic SARS-CoV-2,”
It Is Time to Face Reality about the Vaccines A number of studies are converging on the fact that 2 doses of vaccination has poor vaccine effectiveness against Omicron. 3 doses does slightly better, but the effect will rapidly wane as antibody titers fall, and infection is certain as the number of exposures increase. These studies have immediate implications for vaccine and health-care policies. First, Kaiser Southern California. Here are data for 2 doses of mRNA for effectiveness against Omicron. Follow the red line. Over time, it is 0%.
As of Jan. 20, there are 740 unvaccinated, and 2,091 fully vaccinated people
Graphs and tables of COVID-19covid 19 hospitalization data by status, location and number of people in the ICU.
Our goal is not eradication of the virus, or a one-size-fits-all policy, but lessening of deaths in the vulnerable through focused protection, and focused vaccination. The immunity we have will be a mix of vaccine immunity and natural immunity, depending on the person.
The view of 60,000 public health scientists and physician signatories
We shall find out, as we observe the unvaccinated, to what extent natural immunity, accumulating in waves of infection over time, does or does not protect, for the current or future variants.
61% of the world population has received at least one dose of a COVID-19 vaccine. 10.08 billion doses have been administered globally, and 22.67 million are now administered each day. Only 10% of people in low-income countries have received at least one dose. Our international COVID-19 vaccination dataset is updated each morning (London time), with data up to the previous day.