|
"Chemotherapy, though still primordial, must eventually provide the ultimate solution to vaccine failures."
Influenza A is a viral disease of global dimension, presenting with high morbidity and mortality in annual epidemics, and in pandemics which are of infrequent occurrence but which have very high attack rates. Influenza probes reveal a continuing battle for survival between host and parasite in which the host population updates the specificity of its pool of humoral immunity by contact with and response to infection with the most recent viruses which possess altered antigenic specificity in their hemagglutinin (HA) ligand. HA ligand binds the virus to the cell to bring about infection. Viral survival relies on escape from host immunity through antigenic alterations in nature which arise through genetic drift by point mutation principally of the HA gene, or through genetic shift by reassortment exchange of the HA ligand with that of viruses retained in avian species. Partial control of influenza is by use of killed whole, subunit, or possible live virus vaccines, all of which rely on worldwide surveillance to provide early detection of the altered immunologic specificity of the next virus to come. Future global surveillance may be aided by studies of sampled viral isolates in laboratories having capabilities for accelerated genetic sequencing and for automated rapid throughput analyses as well. Influenza vaccines of the future must be directed toward use of conserved group-specific viral antigens, such as are present in transitional proteins which are exposed during the fusion of virus to the host cell. Chemotherapy, though still primordial, must eventually provide the ultimate solution to vaccine failures. Probing the enigma of the severe influenza pandemic of 1918-1919 is an exciting contemporary venture in which genetic reconstruction of the viral genome from surviving archival RNA is being conducted with great success. Present evidence reveals successive recycling in pandemics, of only 3 of the 15 possible avian viral HAs. Pandemics are believed, conventionally, to be derived solely by rare events in which wild viruses of man acquire a new HA ligand of avian origin. There might be an alternative possibility involving a periodicity in selective control by the host population itself, in its receptivity or rejection at a particular time of particular reassortant viruses which might be created more frequently in nature than we are presently aware. This hypothesis, though remote, provides a different way to view and to probe the enigma of pandemic influenza.
|
Another HIV vaccine strategy fails in large-scale study
By Jon CohenFeb. 3, 2020 , 8:00 AM
The failure-ridden search for a vaccine that can stop the AIDS virus has delivered yet another frustrating defeat. The HIV vaccine that had moved furthest along in human testing does not work, and the $104 million trial in South Africa evaluating it has been stopped early. “There’s absolutely no evidence of efficacy,” says Glenda Gray, who heads the study and is president of the South African Medical Research Council (MRC). “Years of work went into this. It’s a huge disappointment.”
The efficacy study, which began in October 2016, is known as HVTN 702. It enrolled 5407 sexually active, HIV-uninfected men and women between 18 and 35 years of age at 14 sites across the country. Researchers randomly assigned half of the participants to receive a pair of HIV vaccines used in a one-two punch called a prime boost, whereas the other half received placebo shots. The trial was supposed to last until July 2022. But on 23 January, an independent monitoring board that takes scheduled, sneak peaks at the data to evaluate safety and efficacy, informed Gray and the other leaders of the study that it was “futile” to continue. There were 129 infections in the vaccinated group and 123 in those who received the placebo. “I was catatonic,” Gray says.
|
Fauci tells Congress: 'There's no guarantee that the vaccine is actually going to be effective'He also warned there's a potential for a vaccine to make the course of the disease even stronger.
Another worry among epidemiologists, Fauci said, is that the vaccine backfires and strengthens the virus.
There have been at least two vaccines in the past that have produced a "suboptimal response," he said. "And when the person gets exposed, they actually have an enhanced pathogenesis of the disease, which is always worrisome. So we want to make sure that that doesn't happen. Those are the two major unknowns."
|
Dr Fauci told Fox News that the UK did not review the vaccine "as carefully" as US health regulators.
Thursday he walked back the comments, and said there was "no judgement on the way the UK did it". The BBC changed this story within minutes of ut being published:
|
No vaccine for coronavirus a possibility
An eminent Australian vaccine inventor says COVID-19 may never have a preventive vaccine, but could possibly burn out.
Professor Ian Frazer, the immunologist who co-invented the human papilloma virus (HPV) vaccine which prevents cervical cancer, said a coronavirus vaccine was “tricky”.
He told news.com.au that although 100 different teams around the world were testing for vaccines, medical scientists did not have a model of how to attack the virus.
The professor of medicine at Queensland University, which is testing for its own COVID-19 vaccine, said immunisation against coronavirus was similar to immunising against the common cold.
At the moment we don’t know how to make a coronavirus vaccine work. “That’s why there are 100 vaccines under testing using every conceivable approach. “We don’t know if any of them will work.”
Prof Frazer said a vaccine for the 2003 SARS (severe acute respiratory syndrome) outbreak was never successfully developed and then the virus burnt out.
Prof Frazer explained the annual vaccines prepared against the winter flu by the Commonwealth Serum Laboratories (CSL) were not entirely effective. Each year CSL “takes about a quarter of Australia’s egg supply to make the vaccine,” he said. “We purify the protein parts of the virus out of the eggs and make the vaccine out of that. “But it’s not 100 per cent effective at all … for older people (because) as your immune system gets weaker as you get older.
|
"Even a vaccine that works likely won’t solve the pandemic"
When William Haseltine told a group of fellow scientists in 1986 that an AIDS vaccine would be unlikely because of the difficult nature of the virus, he was booed off the stage. His colleagues even threw stuff at him.
“But we still don’t have a vaccine for AIDS,” he recently told Reuters. “We don’t know for sure that a [COVID-19] vaccine won’t be developed, but I can say with the same conviction — don’t count on it.”
In the last couple of weeks the virologist also has offered some jarring observations on the nature of the coronavirus, self-promotion by drug labs, the hazards of rapid reopenings and our global unpreparedness for what is yet to come.
Over his career he worked on or developed drugs for HIV/AIDS, anthrax, and other ailments. The 76-year-old is also an expert on aging and dementia. And he started up Human Genome Sciences with Craig Venter in 1992.
Here, then, are eight cautions by William Haseltine that, while hard to hear, may save many lives if heeded.
1. Beware of those who purvey premature hope.
2. Even a vaccine that works likely won’t solve the pandemic.
3. A flattened curve is not a road to victory.
4. ‘Herd immunity’ is a dubious prospect.
5. We remain woefully unprepared.
6. Nature is not nearly as controllable as we wish.
7. Much bigger threats loom.
8. Changes in behaviour can save us now. And far more certainly than any vaccine.
For starters the most affected population, people over the age of 60, are the most difficult population to develop vaccines for. As the immune system ages, the effectiveness and duration of vaccines wanes with it. “It is very difficult to develop a vaccine for older people,” notes Haseltine.
Second, coronaviruses make difficult vaccine candidates because they produce many proteins that allow them to trick and evade the immune system.
SARS-CoV-2 can play tricks with the immune system in a way other viruses can’t. The human immune system offers a two-pronged response to a viral invasion. One response produces antibodies which bind to the virus and eliminate the intruder. The other response more directly attacks infected cells. But SARS-CoV-2 can mute the first response and make the other hyperactive says Haseltine. “SARS-[CoV]-2 is amplifying what happens to us naturally as our immune systems age.”
As a result experiments with vaccines for SARS and MERs have not ended well. Some generated neutralizing antibodies, but they didn’t provide adequate protection, says Haseltine.
Third, Haseltine doesn’t think an adenovirus-based vaccine such as the one proposed by CanSino Biologics, and now being tested in Halifax, will do the trick either.
Haseltine reported in Forbes that the antibody response in the older test group, ages 50 to 60, was “less robust that younger volunteers.” So how is that product going to work in an elderly population “known to mount poor long-term immune responses to novel infections?”
“We don’t know whether the vaccine will offer sterilizing, long-lasting immunity — as hoped — or only transient, partial protection, as seems more likely.”
More on Haseltine's blog.
|
Why there are no coronavirus vaccines
Dr. Peter Hotez explaining how respiratory vaccines often make the disease worse.
|
Vaccinations, Vitamin C, Politics, and the Law
Even the most ardent of vaccine supporters should be able to admit that vaccinations, however infrequently, sometimes result in an undesired outcome on the health status of the recipient. The "argument" then shifts as to whether the chance of such an outcome is so rare as to be reasonably and permissibly ignored. The pro-vaccine community maintains that population-wide vaccinations confer a high degree of protection against even more morbidity and mortality that would otherwise be inflicted by the diseases or conditions for which the vaccines are being given. However, here I emphasize the need for mitigation of the side effects of vaccination.
|
"The CDC reported that only 63% of Health Care Workers polled over several months would get a Covid-19 vaccine"
29% Want to see a long term followup. (more than one year)
12% Want to see a long term followup. (less than one year)
11% Would not take under any condition.
8% Would not take because pregnancy/breastfeeding.
6% Would not take because of side effects
6% Wanted to see others get it first.
6% Need more clinical study.
5% Felt studies were rushed.
4% Had severe allergies or reactions to vaccines
1% Religious objection
1% Political objection.
|
"Such abbreviated regulatory pathways and
fast-tracked deployments, which are still widely regarded
as experimental interventions, in the context of a public
health emergency of international concern, are unprecedented."
The European Medicines Agency has reportedly indicated
its willingness to approve a candidate COVID-19
vaccine with efficacy of less than 50%,16 which is less
than the threshold set by the FDA for COVID-19 vaccines
and the European Medicines Agency’s requirement
for influenza vaccines.8
To facilitate COVID-19 candidate
vaccines attaining emergency use designation, the
European Medicines Agency has started rolling reviews
of leading candidate vaccines, which enable European
regulators to quickly analyse results as they become
available, rather than wait for a full application.8
The UK’s
Medicines and Healthcare products Regulatory Agency
has adopted a similar approach.17
Russia18 and China19–21 have initiated the mass roll-out
of state-sponsored domestic candidate vaccines to
certain population cohorts on the basis of relatively
sparse data. Such abbreviated regulatory pathways and
fast-tracked deployments, which are still widely regarded
as experimental interventions, in the context of a public
health emergency of international concern, are unprecedented.
Even before Chinese vaccine developers had
applied to Chinese authorities for emergency use authorisation
for their vaccines on Nov 25, 2020,22 countries,
such as Indonesia,23 had indicated their intent to initiate
widespread programmatic roll-out of Chinese and
Russian candidate vaccines based on early interim data
from trials in the Middle East and South America.
Meanwhile, São Paulo’s Health Secretary has announced
that he expects Brazil’s drug regulator to approve the use
of China’s candidate vaccine by January, 2021.24
Other countries, such as Venezuela,25 the United Arab
Emirates,26 and the Philippines27 have also indicated
their intent to commence programmatic deployment of
Russian and Chinese vaccine candidates by early 2021.
However, production constraints28,29 could temper these
ambitious aspirations.
As many settings do not have domestic emergency use
regulatory mechanisms,30 or the expertise to vet
candidate vaccines, or both, to assist WHO member
states and UN procurement agencies on decision
making regarding the use of products in a public health
emergency, WHO has established an emergency use
assessment and listing procedure31 to expedite the
availability of medical products (including vaccines)
needed in public health emergencies “based on an
essential set of available quality, safety, and
efficacy/immunogenicity/ performance data”.32,33 WHO’s
evaluation will determine “whether, in light of available
WHO/international standards, the submitted data
demonstrate a reasonable likelihood that the vaccine
quality, safety and efficacy are acceptable and that the
benefits outweigh the foreseeable risks and uncertainties”
in the context of a public health emergency of
international concern.31 Such risks and uncertainties are
poorly characterised. Although not a regulatory authority,
the Pan American Health Organization recommends
that national regulatory authorities consider WHO a
trusted and reference authority for reliance on prequalified
products or WHO products on emergency use
lists.34 WHO putting candidate COVID-19 vaccines on
emergency use lists will probably catalyse the rapid
adoption and roll-out of these vaccines in member
countries, especially in low-income and middle-income
settings that have entered into advanced purchase
agreements with vaccine developers through financing
schemes with sovereign development banks from the
countries that developed the vaccines.
|
Introduction to SARS2 vaccines
"Even without challenge trials, accelerated testing may run the risk of missing potential side effects. A vaccine for dengue fever, and one for SARS that never reached the market, were abandoned after making some people more susceptible to severe forms of the diseases, not less."
|
People are not being told the vaccine could make COVID-19 worse: Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus.
Informed consent procedures for vaccine trials commonly include disclosure of very minor risks such as injection site reactions, rare risks from past, unrelated vaccines/viruses, such as Guillain‐Barre syndrome for swine flu (interest in which is likely behind the interest in Astra Zeneca's recent vaccine transverse myelitis event) and generic statements about the risk of idiosyncratic systemic adverse events and death. Specific risks to research participants derived from biological mechanism are rarely included, often because of ambiguity about their applicability.
Thus, a finite, non‐theoretical risk is evident in the medical literature that vaccine candidates composed of the SARS‐CoV‐2 viral spike and eliciting anti‐SARS‐CoV‐2 antibodies, be they neutralising or not, place vaccinees at higher risk for more severe COVID‐19 disease when they encounter circulating viruses. Indeed, studies in mice of prior SARS vaccines revealed this exact phenotype, with four human vaccine candidates eliciting neutralising antibodies and protecting against SARS challenge, but viral re‐challenge of thus vaccinated animals resulting in immunopathologic lung disease. 5 Independently, SARS/MERS vaccine candidates, commonly exhibited ADE associated with high inflammatory morbidity in preclinical models, obstructing their advancement to the clinic. 4 , 12 SARS ADE of both disease in non‐human primates and viral infection of cells in vitro was clearly mapped to specific antibody‐targeted SARS viral spike epitopes. 6 This phenomenon was consistent across a variety of vaccine platforms, including DNA, vector primes and virus‐like particles (VLP), irrespective of inoculation method (oral, intramuscular, subcutaneous, etc). An unknown variable is how long this tissue damage lasts, possibly resulting in permanent morbidity (eg, diabetes from pancreatic damage 7 ).
|
But “the looming question,” Fauci said during a White House coronavirus response briefing last week, is whether a person infected despite vaccination can still, unwittingly, infect someone else.
At least for now, people should follow the same rules as everybody else about wearing a mask, keeping a 6-foot distance and avoiding crowds — even after they’ve gotten their second vaccine dose.
Vaccines in use so far require two doses, and experts say especially don’t let your guard down after the first dose.
“You’re asking a very logical question,” Dr. Anthony Fauci, the top U.S. infectious disease expert, responded when a 91-year-old California woman recently asked if she and her vaccinated friends could resume their mah-jongg games.
In that webcast exchange, Fauci only could point to the CDC’s recommendations, which so far are mum about exceptions for vaccinated people getting together. “Hang on,” he told the woman, saying he expected updates to the guidelines as more people get the coveted shots.
What experts also need to learn: The vaccines are highly effective at preventing symptomatic COVID-19, especially severe illness and death — but no one yet knows how well they block spread of the coronavirus.
It’s great if the vaccine means someone who otherwise would have been hospitalized instead just has the sniffles, or even no symptoms.
But “the looming question,” Fauci said during a White House coronavirus response briefing last week, is whether a person infected despite vaccination can still, unwittingly, infect someone else.
Studies are underway to find out, and hints are starting to emerge. Fauci pointed to recent research from Spain showing the more coronavirus an infected person harbors — what’s called the viral load — the more infectious they are. That’s not surprising, as it’s true with other illnesses.
Some preliminary findings from Israel have suggested people infected after the first vaccine dose, when they’re only partially protected, had smaller viral loads than unvaccinated people who got infected. That’s encouraging if the findings hold up. Israel has vaccinated a large fraction of its population and scientists worldwide are watching how the outbreak responds as those inoculations increase.
|
Vaccines are a tool, not a silver bullet. If we’d allowed more scientific debate, we would have realized this earlier
More than two years since COVID-19 emerged, our kit of solutions – and the mindset needed to use them – is too small. It’s time to listen to the science in a broader way.
Also reappraising is Bill Gates himself. He admitted this past November, “We need a new way of doing the vaccines.” He also accepted that our focus had been too narrow. “We didn’t get much in the way of therapeutics … way less than should have been the case.”
|
Are vaccine mandates reasonable?
Over the past few months, I’ve heard many concerns about vaccine mandates voiced privately, but very little public debate on the issue in Canada. (Though the tide is now turning, with Norman Doidge’s excellent opinion piece this weekend in The Globe and Mail.)
To my view, mandating a medical intervention represents a major change in our society and requires robust discussion — particularly when it’s tied to people’s livelihoods.
Some questions to consider: Are workplace mandates likely to withstand legal challenges? Are they logical? Can they be defended with scientific evidence?
To address these questions, I reached out to an expert in the field. Dionne Pohler is a social scientist, and an associate professor at the University of Saskatchewan Edwards School of Business. Pohler’s research covers labour and employment, organizational governance, and public policy implementation, and she argues that the mandates may not hold up. Here, she explains why
|
501 Deaths + 10,748 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show
These numbers reflect the latest data available as of Jan. 29 from the CDC’s Vaccine Adverse Event Reporting System website. Of the 501 reported deaths, 453 were from the U.S. The average age of those who died was 77, the youngest was 23.
|
|
|
|
"...this strategy has never yielded a vaccine approved for human use."
oderna works on RNA vaccines—injecting not proteins but the molecules of nucleic acid that encode the instructions for building the proteins. Your cells use RNA to instruct their builders to make proteins all the time; the RNA is like the blueprints or schematics that tell the workers on the factory floor what to build. An RNA vaccine injects instructions to your cells, and hopes that your cells receive these instructions and follow them, and build the proteins that will teach your immune system to fight a virus. It is a bit like wadding up plans for a Cessna, throwing them through the ventilation shaft of a Ford factory, and hoping that someone inside finds them, and that the factory starts rolling airplanes out its doors instead of pickups.
Despite successes in animals, this strategy has never yielded a vaccine approved for human use. Moderna is a leader in this approach, and you can be sure the scientists there have considered all the ways to make it more likely to work. They throw the plans down the shaft nearest the factory manager’s office; they attach official-looking paperwork and bribes. But their approach is ambitious. If it works in humans, it will represent a huge advance in immunology and clinical medicine.
The RNA-vaccine approach has one great advantage: speed. Scientists merely need to know the virus’s genetic sequence, and they can synthesize and scale up production of an RNA vaccine in a matter of weeks. RNA is fragile. In a lab, you have to shield your face to work with it, not because it is dangerous but because you are dangerous to it. Even a gust of saliva is likely to contain enzymes that would rip RNA apart, rendering it worthless. As long as it’s formulated properly, RNA is considered nearly harmless to inject into humans, and a Phase 1 trial like this is easy to begin. Success is hardly assured, but we at least know that the RNA won’t hurt the people in the trial who are being paid $1,100 to have it injected into them. It is a clever approach—but don’t eat through your boxes of stockpiled wholesale ramen too quickly, because no one can or should guarantee that an RNA vaccine will stop the pandemic anytime soon.
|
Researchers fast-track coronavirus vaccine by skipping key animal testing first
A clinical trial for an experimental coronavirus vaccine has begun recruiting participants in Seattle, but researchers did not first show that the vaccine triggered an immune response in animals, as is normally required.
Now, biomedical ethicists are calling the shortcut into question, according to Stat News.
|
Beta variant in France a ‘threat’ as it evades all vaccines immune response
IT was announced on Friday evening that holidaymakers returning from France must continue to quarantine for 10 days – even if they are double jabbed.
|
Virus infects vacciated people, it's the unvaccinated's fault
Even as many Americans celebrate the apparent waning of the pandemic, the thrum of concern over the so-called Delta variant grows steadily louder.
The variant, the most contagious version yet of the coronavirus, accounts for more than half of new infections in the United States, federal health officials reported this month. The spread of the variant has prompted a vigorous new vaccination push from the Biden administration, and federal officials are planning to send medical teams to communities facing outbreaks that now seem inevitable.
Infections, hospitalizations and deaths are rising swiftly in some states with low vaccination rates like Arkansas, Missouri, Texas and Nevada, and are beginning to show small upticks in all of the others. The curves have also begun shifting upward in New York City, and the percentage of positive tests in the city has doubled in the past few weeks to just over 1 percent.
|
Vaccine protection lasts less than a year
Unlike other vaccines, re-infection can occur.
|
Data error means completed Ontario COVID-19 vaccinations only half of what was reported
Ontario has been over reporting the number of people who have been fully vaccinated against COVID-19 in the province, the Ministry of Health said Thursday.
The error means that the number of people who have received both doses of either the Pfizer-BioNTech or Moderna vaccines is only half of what the province has been logging.
"Rather than provide data on the number of people who have been fully vaccinated … officials inadvertently provided data on the number of doses administered to achieve full vaccination," a spokesperson for the ministry said in a statement sent to media.
Data on the total number of doses administered was not affected, the spokesperson said.
|
By the FDA’s own definition, the vaccines are still considered experimental until fully licensed.
"Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.20. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist."
|
Federal Law Prohibits Mandates of Emergency Use COVID Vaccines
“Federal law, Title 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(I-III) of the Federal Food, Drug, and Cosmetic Act, states the following about products granted emergency authorization usage:
Individuals to whom the product is administered are informed—
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
Any entity or organization that requires EUA COVID-19 vaccinations, COVID-19 tests or masks are in violation of federal law, and will likely face lawsuits if they don’t allow exemptions or alternatives.”
|
Vaccine rollout will trigger new Covid variants, Oxford scientist warns, adding ‘new layer of complexity’ to pandemic fight
A senior scientist at Oxford University has warned the global rollout of Covid-19 vaccines will prompt the virus to mutate, driven by “immunological selection” rather than the adaptations we have seen so far.
Speaking to the UK Commons Science and Technology Committee on Wednesday, Professor Sir John Bell, Oxford’s regius professor of medicine, said that the Covid-19 mutations observed so far are a result of the virus adapting to be more effective in its new hosts, humans.
“Most of the variants we have seen so far represent that kind of adaptation to a new species; it’s a bit like moving into a new apartment, you are shuffling the sofa around and making sure the TV is in the right place,” Bell told colleagues and lawmakers.
“What we will see between now and the end of the year is a number of variants which are driven by immunological selection, largely by the vaccines, and that will add another layer of complexity.”
|
Rampant infection in the Seychelles where more than 60 percent of its population have been innoculated
For months, public health experts had focused on trying to close the access gap between rich and poorer nations. Now, scientists are warning that developing nations that choose to use the Chinese vaccines, with their relatively weaker efficacy rates, could end up lagging behind countries that select vaccines made by Pfizer-BioNTech and Moderna. That gap could allow the pandemic to continue in countries that have fewer resources to fight it.
“You really need to use high-efficacy vaccines to get that economic benefit because otherwise they’re going to be living with the disease long term,” said Raina MacIntyre, who heads the biosecurity program at the Kirby Institute of the University of New South Wales in Sydney, Australia. “The choice of vaccine matters.”
Nowhere have the consequences been clearer than in Seychelles, which relied heavily on a Sinopharm vaccine to inoculate more than 60 percent of its population. The tiny island nation in the Indian Ocean, northeast of Madagascar and with a population of just over 100,000, is battling a surge of the virus and has had to reimpose a lockdown.
Among the vaccinated population that has had two doses, 57 percent was given Sinopharm, while 43 percent was given AstraZeneca. Thirty-seven percent of new active cases are people who are fully vaccinated, according to the health ministry, which did not say how many people among them had the Sinopharm shot.
|
How a Covid-19 Vaccine Could End Up Helping the Virus Spread
It may be possible to infect others even after getting a shot.
The vaccinated people might stop wearing masks and social distancing since they aren’t themselves at risk anymore. They could be carrying the SARS-CoV-2 virus, even if they’re not getting sick from it.
How big a problem this might be is hard to say, because we don't know for sure if immunized people are capable of shedding infectious virus. It's possible that their antibodies will eradicate any infection pretty quickly, so they might just shed viral debris. Pfizer and the Centers for Disease Control and Prevention did not immediately respond to requests for comment.
It’s also not yet clear how much protection the Pfizer-BioNTech vaccine and others would provide. The gold standard is to achieve sterilizing immunity, which is so strong that the virus can’t get a grip in the body at all—meaning that vaccinated people are safe to others.
But sterilizing immunity is hard to achieve with viruses such as SARS-CoV-2, which enter through the respiratory system. The only sure way to know if the vaccine provides sterilizing immunity would be to check whether trial subjects who remain free of Covid-19 have been exposed to it, by tracing their contacts.
The Pfizer-BioNTech vaccine and others might provide just functional immunity—protecting people from the full-blown disease but not from carrying the virus. Functional immunity may also be what people get from being infected by the disease itself. They can catch it again, but will have fewer, if any, symptoms. We already know that people who are asymptomatic can spread Covid-19. In fact, that’s one of its scariest characteristics.
Bloomberg’s Jason Gale raised this issue with Paul Griffin, a professor in the faculty of medicine at the University of Queensland in Australia. Griffin, who is an investigator on four Covid-19 vaccines that do not include the Pfizer-BioNTech one, said that while it might turn out that vaccinated people can transmit the disease, transmission is far more likely if people are coughing and sneezing. “So if we are preventing clinical disease, then that will go a long way to reducing transmission as well, even if it's not precisely a transmission-blocking vaccine,” Griffin said on Nov. 10.
In other words, under the right conditions, a vaccine can and should suppress the transmission of Covid-19. But if people who get vaccinated throw caution to the winds, it’s possible they could get a lot of other people sick.
|
WHO Recommends Against Moderna, Pfizer Vaccines for Most Pregnant Women
Neither Moderna nor Pfizer enrolled pregnant women in their Covid-19 vaccine trials, and both say they plan future study
|
Four Russian doctors contract Covid-19 despite being vaccinated
Four doctors who received Russia’s Sputnik V Covid-19 vaccine have subsequently tested positive for the virus, sparking doubts about its effectiveness. But scientists have cautioned that the formula takes time to provide immunity.
The first three infections were reported on Wednesday in the Altai Region, near the border with Kazakhstan. According to the chief infectious disease specialist in the region, they caught Covid-19 after being vaccinated, but before protection had fully formed.
|
Brexit: EU introduces controls on vaccines to Northern Ireland
The EU is introducing controls on vaccines made in the bloc, including to Northern Ireland, amid a row about delivery shortfalls.
Under the Brexit deal, all products should be exported from the EU to Northern Ireland without checks.
But the EU believed this could be used to circumvent export controls, with NI becoming a backdoor to the wider UK.
NI First Minister Arlene Foster described the move as "an incredible act of hostility" by the EU.
The EU invoked Article 16 of the Northern Ireland Protocol which allows parts of the deal to be unilaterally overridden.
In a new regulation, the European Commission stated: "This is justified as a safeguard measure pursuant to Article 16 of that Protocol in order to avert serious societal difficulties due to a lack of supply threatening to disturb the orderly implementation of the vaccination campaigns in the Member States."
|
US government website for collecting adverse events after vaccination is inaccessible to most users
1. Over 284 US cases of acute flaccid myelitis have been reported since August, 2014. (CDC, Acute flaccid myelitis, 4/20/17) The CDC and other authorities seem to have avoided investigating the possibility that vaccinations and provocation paralysis are co-factors in the causation of this terrible disease. (Cunningham, unpublished manuscript, 1/8/17, and many personal communications since January 30, 2015)
2. The 20% increase in autism spectrum disorder among the offspring of women who received the flu shot during the first trimester of pregnancy was dismissed as "non-significant" after an odd statistical manipulation. (Zerbo et al, JAMA Pediatr, 11/28/16 online) Donzelli and colleagues asserted that the statistics were not appropriate and that the risk increase, which meant 4 extra ASD cases for every 1000 women vaccinated, should be taken seriously. (JAMA Pediatr, 4/24/17 online)
3. Doshi states that, "no more than 10% of adverse events" get reported to VAERS, but the situation is much worse. From 1990 to 2007 there were about 80,000 US cases of Kawasaki disease; during the same period just 56 US cases were reported to VAERS--0.07%. (Hua et al, Pediatr Inf Dis J 2009: 28:943-947) The cause of KD is unknown; it is rare, it is very serious, and it is prevalent among young and frequently vaccinated children. If any event deserves prompt reporting to VAERS it is Kawasaki disease, but this does not happen.
The randomized trials leading to vaccine licensure are typically too small to statistically validate the occurrence of rare but serious adverse events, so this is left to postmarketing surveillance ("pharmacovigilance"). However, conscientious postmarketing surveillance simply does not occur....Walter Spitzer was a distinguished professor of epidemiology at McGill University. He once dryly observed: "The best way to remain in the dark about vaccine safety is not to look for it. One way not to look, but pretend to be looking, is to study small samples." (Spitzer, 'Is MMR linked to autism?' Testimony before the Government Reform Committee, US House of Representatives, April 25, 2001)
Meanwhile, US vaccine authorities are trying to mandate every vaccine on the immunization schedule for every child, regardless of the frequency, severity, and transmissibility of the target diseases, and regardless of serious limitations in our knowledge of long-term safety and effectiveness for many of the newer vaccines. (AAP committees, Statement on vaccine exemptions, Pediatrics 2016; 138:e20162145.) Breathtaking!
|
Coronavirus: WHO warns "while there is hope for a vaccine against Covid-19, one might never be found."
The head of the World Health Organization (WHO) has said that while there is hope for a vaccine against Covid-19, one might never be found.
Tedros Adhanom Ghebreyesus told a news briefing there was "no silver bullet at the moment - and there might never be".
Mr Tedros implored people around the world to comply with measures such as social distancing, hand-washing and mask-wearing, saying: "Do it all."
Globally, more than 18 million Covid-19 infections have been recorded.
The death toll stands at 689,000, with both figures given by the US-based Johns Hopkins University.
|
|
|
