A handful of the dozens of experimental COVID-19 vaccines in human testing have reached the last and biggest hurdle — looking for the needed proof that they really work as a U.S. advisory panel suggested Tuesday a way to ration the first limited doses once a vaccine wins approval.
AstraZeneca announced Monday its vaccine candidate has entered the final testing stage in the U.S. The Cambridge, England-based company said the study will involve up to 30,000 adults from various racial, ethnic and geographic groups.
Two other vaccine candidates began final testing this summer in tens of thousands of people in the U.S. One was created by the National Institutes of Health and manufactured by Moderna Inc., and the other developed by Pfizer Inc. and Germany’s BioNTech.
“To have just one vaccine enter the final stage of trials eight months after discovering a virus would be a remarkable achievement; to have three at that point with more on the way is extraordinary,” Health and Human Services Secretary Alex Azar said in a statement.
NIH Director Francis Collins tweeted that his agency “is supporting several vaccine trials since more than one may be needed. We have all hands on deck.”
AstraZeneca said development of the vaccine, known as AZD1222, is moving ahead globally with late-stage trials in the U.K., Brazil and South Africa. Further trials are planned in Japan and Russia. The potential vaccine was invented by the University of Oxford and an associated company, Vaccitech.
Meanwhile, a U.S. advisory panel released a draft plan Tuesday for how to ration the first doses of vaccine. The National Academies of Sciences, Engineering and Medicine proposed giving the first vaccine doses — initial supplies are expected to be limited to up to 15 million people — to high-risk health care workers and first responders.
Next, older residents of nursing homes and other crowded facilities and people of all ages with health conditions that put them at significant danger would be given priority. In following waves of vaccination, teachers, other school staff, workers in essential industries, and people living in homeless shelters, group homes, prisons and other facilities would get the shots.
Healthy children, young adults and everyone else would not get the first vaccinations, but would be able to get them once supplies increase.
The National Academies will solicit public comments on the plan through Friday.
There’s a good reason so many COVID-19 vaccines are in development.
“The first vaccines that come out are probably not going to be the best vaccines,” Dr. Nicole Lurie, who helped lead pandemic planning under the Obama administration, said at a University of Minnesota vaccine symposium.
There’s no guarantee that any of the leading candidates will pan out — and the bar is higher than for COVID-19 treatments, because these vaccines will be given to healthy people. Final testing, experts stress, must be in large numbers of people to know if they’re safe enough for mass vaccinations.
They’re made in a wide variety of ways, each with pros and cons. One problem: Most of the leading candidates are being tested with two doses, which lengthens the time required to get an answer — and, if one works, to fully vaccinate people.
Another: They’re all shots. Vaccine experts are closely watching development of some nasal-spray alternatives that just might begin the first step of human testing later this year — late to the race, but possibly advantageous against a virus that sneaks into the airways.
For now, here’s a scorecard of vaccines that already have begun or are getting close to final-stage tests:
GENETIC CODE VACCINES
The Moderna and Pfizer candidates began Phase 3 testing in late July.
Neither uses the actual coronavirus. Instead, they’re made with the genetic code for the aptly named “spike” protein that coats the surface of the coronavirus. Inject the vaccine containing that code, called mRNA, and the body’s cells will make some harmless spike protein — just enough for the immune system to respond, priming it to react if it later encounters the real virus.
These mRNA vaccines are easier and faster to make than traditional vaccines, but it’s a new and unproven technology.
TROJAN HORSE VACCINES
Britain’s Oxford University and AstraZeneca are making what scientists call a “viral vector” vaccine but a good analogy is the Trojan horse. The shots are made with a harmless virus — a cold virus that normally infects chimpanzees — that carries the spike protein’s genetic material into the body. Once again, the body produces some spike protein and primes the immune system, but it, too, is a fairly new technology.
Two possible competitors are made with different human cold viruses.
Shots made by Johnson & Johnson began initial human studies in late July. The company plans to begin Phase 3 testing in September in as many as 60,000 people in the U.S. and elsewhere.
China’s government authorized emergency use of CanSino Biologics’ adenovirus shots in the military ahead of any final testing.
‘KILLED’ VACCINES
Making vaccines by growing a disease-causing virus and then killing it is a tried-and-true approach — it’s the way Jonas Salk’s famed polio shots were made. China has three so-called “inactivated” vaccine candidates against COVID-19 made this way.
Sinovac has final studies of its candidate underway in Brazil and Indonesia. Competitor SinoPharm has announced plans for final testing in some other countries.
Safely brewing and then killing the virus takes longer than newer technologies. But inactivated vaccines give the body a sneak peek at the germ itself rather than just that single spike protein.
PROTEIN VACCINES
Novavax makes “protein subunit” vaccines, growing harmless copies of the coronavirus spike protein in the laboratory and packaging them into virus-sized nanoparticles.
There are protein-based vaccines against other diseases, so it’s not as novel a technology as some of its competitors. But it only recently finished its first-step study; the U.S. government’s Operation Warp Speed aims for advanced testing later in the fall.
(AP)
Join the official YWN WhatsApp status
4 Responses
to have three at that point with more on the way is extraordinary, Kudos to our extraordinary President Donald Trump for spearheading these vaccines so effusively, and May he merit to win extraordinarily gigantic landslide come November 3rd.
with late-stage trials in the U.K., Brazil and South Africa The רפואה always comes before the מכה. Thank G-D for Brexit on January 31st, 2020, and now U.K. is liberated from all this EU red-tape, and is in late stage trials on Vaccination.
There were only 9k deaths from COVID-19 in America. The rest died with 2-4 other diseases, such as heart diseases, cancer, HIV, etc. This is too be expected, as millions of people die every year in America. Plus there is no test for COVID-19, that would take years to make. They are just checking for the RNA sequence, which you could have if you have the flu. This is because the Flu is also a Coronavirus. So it’s not anywhere near as deadly as the flu (40-80k deaths a year in USA). No need to take vaccine and surrender your body to Bilaam Gates , along with the microchip. It’s not a “conspiracy theory” when he’s literally saying they are going to be doing this soon
August 26th, 2020
Anthony Fauci, MD, Director
National Institute of Allergy and Infectious Disease
RE: Phase III Moderna mRNA-1273 Vaccine
Dear Dr. Fauci,
We urge you to require Moderna to inform clinical trial participants of the unique risks associated with polyethylene glycol (PEG), an ingredient in the NIAID funded Moderna mRNA-1273 vaccine. As you know, approximately 72% of Americans may have antibodies to PEG with 8% of those individuals having highly elevated levels of antibodies, <500ng/ml.
Injecting a PEG-containing vaccine into individuals with pre-existing PEG antibodies could lead to life-threatening anaphylaxis. The presence of anti-PEG antibodies in approximately 7 out of 10 Americans led to the authors conclusion that “…sensitive detection and precise quantitation of anti-PEG Ab levels in a clinical setting will be essential to ensuring the safe use of PEGylated drugs in all target patient populations going forward.”
In its prospectus, Moderna acknowledges the potential for its proprietary lipid nanoparticles and PEG to produce “systemic side effects”. The company has nevertheless refused to prescreen individuals participating in the clinical trials for preexisting PEG antibodies, despite FDA’s strong recommendations that it do so.
For those participating in the Moderna clinical trials, the uptick in parenteral exposure to PEG will be unprecedented—potentially disastrous and life-threatening. Moderna reported results from the Phase 1 open-label trial in 45 healthy adults acknowledged that over half (23 out of 45) of the participants experienced a vaccine adverse event, including one volunteer who withdrew from the trial due to urticaria (hives), a condition often associated with drug allergies and life-threatening anaphylaxis. We worry that Moderna’s failure to inform the trial participants of the PEG allergy risks not only endangers their lives, but also may have caused clinicians and volunteers to dismiss telltale allergic reactions as “unrelated” to the vaccine.
Children’s Health Defense has grave safety and efficacy concerns about the use of PEG in vaccines due to the high percentage of the population having preexisting antibodies to PEG. While it’s unlikely that everyone with pre-existing PEG antibodies will have a severe reaction to a vaccine containing PEG, it is criminally reckless to assume that none will. It is our hope that you will make the appropriate public assurances that NIAID will promptly inform the volunteers of this risk.
Moderna answers critics of its dangerous failure to warn trial subjects by dismissing the well-documented fact that a high percentage of people have anti-PEG antibodies as merely “hypothetical”. Moderna’s justification is disingenuous, at best. There is no serious dispute about PEG’s ubiquity across the population. Moderna’s refusal to screen for PEG is dangerous to the trial participants and violates 45 CFR 46.116(b)(2). That regulation requires manufacturers to disclose any reasonably foreseeable risks or discomforts to clinical trial subjects. Another provision, 45 CFR 46-111(a) (1) mandates that manufacturers minimize risks to clinical trial participants by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk.
The world is aware of NIAID’s deep institutional commitment to the Moderna Vaccine. Moderna’s novel MRNA vaccine is a career vanity project for certain powerful NIAID officials who have nurtured the platform for years. NIAID apparently owns half of Moderna’s patent. At least six NIAID officials also share patent ownership and apparently stand to collect personal royalties of up to $150,000 annually on vaccine sales. NIAID has committed billions of dollars of public monies to the project and placed the Moderna vaccine at the front of the line. As you know, critics have suggested that NIAID’s conflicts have engendered a posture, among NIAID regulators, of ignoring emerging safety signals because the Moderna Vaccine is “too big to fail”. But, NIAID’s peculiar interest in Moderna is no excuse for short cuts. To the contrary, it is critical that NIAID’s regulatory scrutiny of Moderna be beyond reproach, since other manufacturers will look to Moderna as a role model for their own safety studies. NIAID’s pet vaccine should be a template for rigorous protocols that unambiguously elevate safety above monetary considerations. We urge that you give priority to your agency’s duty to protect public health and the rights of trial participants to genuine informed consent. We ask you to order Moderna to immediately inform all trial participants of the risk for allergic reactions from PEG, and to carefully monitor and publicly disclose allergic reactions potentially associated with PEG.
Sincerely,
Robert F. Kennedy Jr.
cc: President Donald Trump
Jared Kushner
Most well informed people would rather take hydroxychloroquine than this newly off the press vaccine. The media is only promoting the vaccine because Fauci and a bunch of crooked politicians invested heavily in it.