“Governments cannot keep making unrealistic promises about easing restrictions at 70% and 80% adult vaccination, a plan that relied on optimistic scenarios in the first place, and one that now bears little relation to the real world. It is irresponsible to build public momentum and hope around targets that are unlikely going to be enough. Australia needs the National Cabinet to come clean and accept that the changing circumstances require a change in the plan.”
Approval Signifies Key Achievement for Public Health
Immediate Release:August 23, 2021
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
People flocked to the beaches of Tel Aviv when Israel almost completely reopened.(Reuters: Amir Cohen)
Life is set to be very different once 80 per cent of Australians are vaccinated — but one country has shown the dangers of being too confident and throwing out the rest of the COVID toolkit.
Key points:
Israel recently had to reimpose restrictions following a huge surge in COVID-19 cases
The vast majority of new cases were unvaccinated children
Experts say the resurgence proves the vaccine cannot be relied upon alone
“You would still have to respect some rules that exist around vaccinations, around social distancing, around mask wearing [once 80 per cent target is met],” she said.
But Israel, which has almost the same population as Sydney, reopened completely after reaching the 80 per cent mark — and took one giant step backwards.
In recent months, Israel has reopened businesses, schools and event venues, lifting nearly all restrictions.(ABC News: Phil Hemingway)
Israel shot to an early lead in the race to vaccinate, inoculating its citizens at an eye-watering pace to deliver the world’s fastest vaccine rollout.
Around 78 per cent of the eligible population are now fully vaccinated, just shy of the 80 per cent target set for Australia to start to open up.
But in recent weeks Israel has been hit by a surprise resurgence of COVID-19, with seven-day average daily case numbers surging past 6,500 this week.
Epidemiologist Catherine Bennett from Deakin University has been paying close attention to Israel’s experience with COVID-19 and said the new surge of infections was”disappointing”, as it quashed many people’s hopes of a return to normality.
Professor Catherine Bennett, Deakin’s chair of Epidemiology.(ABC News: Peter Drought)
“Everyone would have loved for the story to be a great one where you could live normally and all would be well,” she said.
“They had gone to the future we hoped might be possible… but that was pre-Delta.”
So what went wrong for Israel? Two months ago it appeared the country had all but conquered the virus.
Seven-day average case numbers had toppled from a peak of more than 8,500 in January to a mere handful by June after a successful vaccination campaign, and health authorities were jubilant.
The death rate had also dropped, from an average of over 65 a day in January to near zero by late June, according to data from Johns Hopkins University.
People take part in an annual gay pride parade in Tel Aviv on June 25.(Reuters)
Residents celebrated no longer having to wear a mask or socially distance.Some even travelled overseas, although they were encouraged not to.
But within weeks the Delta variant had entered the country, initially emerging in schools.
“The vast majority of those infected are unvaccinated children. There are also vaccinated individuals [and] the severe cases are among older adults 60 years of age and older,” a statement from Israel’s Ministry of Health said.
Elderly residents who had previously received two doses of the Pfizer vaccine began reporting serious symptoms after contracting the virus, sparking concerns that vaccine effectiveness was wearing off, according to Israeli epidemiologist Nadav Davidovitch.
Professor Davidovitch, who works at Israel’s Ben-Gurion University and is a member of the national expert committee on COVID-19, said Israel had false confidence.
“People were celebrating the end of COVID and this was probably too early,” he said.
Israel learns hard lessons of Delta
Since the explosion of cases, Israel has had to backtrack.
Masks have been reintroduced indoors, and the “green pass” was recently re-imposed, requiring residents to prove their vaccination status before entering certain venues.
‘Green passes’ are required upon entry to facilities like gyms.(Reuters: Ronen Zvulun)
Three weeks ago, Israel began offering third Pfizer shots to the elderly and health care workers, and 1 million booster shots have since been administered.
Israel has also tried incentives such as free beer to win over the hesitant, with more than 1 million people still holding out on receiving the vaccine.
As for calling another lockdown, Professor Davidovitch said the government would resist it for as long as possible.
“For me, lockdowns are only when you’re failing.”
Nadav Davidovitch is an epidemiologist and public health physician in Israel.(Supplied)
He said the main indicator would be if the hospitals were overrun, and said that, fortunately, admissions had halved following the vaccination rollout.
The death rate is also much lower, despite the surging cases.
As of August 17, the seven-day average daily death rate was 19, compared to a seven day average of 65 deaths a day at the peak of Israel’s outbreak in January.
Professor Catherine Bennett said that was one small comfort, but the warning to Australia was clear.
“We know from Israel that opening up completely and [the virus] getting away from you is a problem,” she said.
“Israel relied completely on the vaccine, Australia [should not] do that.”
A man walks past people taking part in a silent disco event in Tel Aviv.(Reuters: Amir Cohen )
Professor Bennett said Australia was more likely to retain some public health safety measures such as testing, tracing and isolating, even after it reached its 80 per cent vaccination target.
“We can’t get to 80 per cent and expect things to magically change if our case numbers are too high.”
As for when complete freedom will be restored, Professor Bennett suggested it might be a slow process.
“If we suppress transmission by two thirds around the world, we might not see another variant emerge as quickly as we saw Delta, which means vaccines targeting Delta will work for longer,” she said.
“This means we will progressively grind it down to a level we won’t see new variants … and the ideal situation is in a year’s time we can treat COVID-19 like other infections such as the measles,” she said.
The FDA’s top vaccine official vowed to complete the process ‘as rapidly as possible,’ but would not speculate on the timetable. Other officials have suggested it could be a matter of weeks.
by Laurie McGinley, August 2, 2021 at 9:00 a.m. EDT
Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Vioxx is also related to the nonselective NSAIDs , such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.30 Sept 2004
How many deaths did Vioxx cause?By the time Vioxx is withdrawn from market, an estimated 20 million Americans have taken the drug. Research later published in the medical journal Lancet estimates that 88,000 Americans had heart attacks from taking Vioxx, and 38,000 of them died.10 Nov 2007
Merck Manipulated the Science about the Drug Vioxx
Published Oct 12, 2017
Scientists from the pharmaceutical giant Merck skewed the results of clinical trials in favor of the arthritis drug, Vioxx, to hide evidence that the drug increased patients’ risk of heart attack. FEATURE
Five tactics business interests use to sideline science, deceive the public and buy influence at the expense of public health and safety.
To increase the likelihood of FDA approval for its anti-inflammatory and arthritis drug Vioxx, the pharmaceutical giant Merck used flawed methodologies biased toward predetermined results to exaggerate the drug’s positive effects. Internal documents made public in litigation revealed that a Merck marketing team had developed a strategy called ADVANTAGE (Assessment of Differences between Vioxx And Naproxen To Ascertain Gastrointestinal tolerability and Effectiveness) to skew the results of clinical trials in the drug’s favor. As part of the strategy, scientists manipulated the trial design by comparing the drug to naproxen, a pain reliever sold under brand names such as Aleve, rather than to a placebo.
The scientists highlighted the results that naproxen decreased the risk of heart attack by 80 percent, and downplayed results showing that Vioxx increased the risk of heart attack by 400 percent. This misleading presentation of the evidence made it look like naproxen was protecting patients from heart attacks, and that Vioxx only looked risky by comparison. In fact, Vioxx has since been found to significantly increase cardiovascular risk, leading Merck to withdraw the product from the market in 2004.
Merck’s manipulation of the science around Vioxx also included a pattern of ghostwriting of scientific articles. Internal documents reveal that in 16 of 20 papers reporting on clinical trials of Vioxx, a Merck employee was initially listed as the lead author of the first draft; on the published versions, an outside academic was listed as the primary author. In one draft of a Vioxx research study that did not yet have a prominent outside name attached, Merck officials listed the lead author only as “External author?” A Merck scientist was also found to have removed the evidence of three heart attacks among patients in a dataset from the results presented.
Tragically, Merck’s manipulation of its data—and the FDA’s resulting approval of Vioxx in 1999—led to thousands of avoidable premature deaths and 100,000 heart attacks. Dr. David Graham, the Associate Director for Science and Medicine in FDA’s Office of Drug Safety, testified in 2004 before the Senate Finance Committee that the FDA’s failure to recall Vioxx earlier had resulted in as many as 55,000 premature deaths from heart attacks and stroke, calling it the equivalent of allowing “two to four jumbo jetliners” to crash every week for five years. Even years after discontinuing use of the drug, patients who have taken Vioxx continue to experience complications.
Our running list of attacks on science—disappearing data, silenced scientists, and other assaults on scientific integrity and science-based policy—provides a representative sample of threats to the federal scientific enterprise.PODCAST
Dr. Topol is director of the Scripps Translational Science Institute, chief academic officer of Scripps Health, professor of genomics at the Scripps Research Institute, and co-founder of the West Wireless Health Institute in La Jolla, Calif. A practicing cardiologist, he has led the flagship, National Institutes of Health-supported Scripps Translational Science Institute since 2006, where he works on innovative genomic and wireless digital technologies aimed at reshaping the future of medicine. Prior to his work at Scripps, Dr. Topol’s efforts are widely credited with leading the Cleveland Clinic to become the foremost center for heart care. While at the Cleveland Clinic, he started a new medical school, led many worldwide clinical trials to advance care for heart disease, and spearheaded the discovery of several genes that increase susceptibility for heart attacks. Dr. Topol pioneered the development of many medications that are routinely used in medical practice, including tissue plasminogen activator, Plavix, Angiomax, and ReoPro. He was the first physician to raise safety concerns about Vioxx. He has published 1100 peer-reviewed articles and more than 30 medical textbooks. He recently became editor-in-chief of the website Medscape. The University of Michigan, where he served on the faculty, established the Eric Topol Professor of Cardiovascular Medicine to recognize his contributions. The University of Rochester, where he attended medical school, awarded him its highest honor, the Hutchinson Medal. In 2012, a poll by Modern Healthcare singled him out as the most influential physician executive in the United States. He was elected to the Institute of Medicine and is one of the top 10 most-cited healthcare researchers. His book, The Creative Destruction of Medicine, was published in 2012.
yEmily Mertz Global News Posted August 10, 2021 6:18 pm Updated August 11, 2021 11:31 am
Global National: Aug 10close video
WATCH (Aug. 5): Dr. Deena Hinshaw, Alberta’s chief medical officer of health, is defending the divisive decision to end the province’s pandemic response plan, despite surging COVID-19 cases. Leave A Comment
The number of active COVID-19 cases in Alberta continued to climb on Tuesday, sitting at 3,463 across the province. Alberta’s active case rate has been rising for the past couple weeks. On July 14, it was 569, by July 26, it had surpassed 1,000, and Aug. 3, it climbed over 2,100 cases. COVID-19 hospitalizations and ICU admissions have also been going up. On Tuesday, there were 133 Albertans in hospital with COVID-19, 29 of whom were being treated in intensive care. That compares to 90 in hospital last Tuesday (23 in ICU) and 82 in hospital (21 in ICU) on Tuesday, July 27. READ MORE: COVID-19: Alberta advocates take fight for health measures in schools to federal government Alberta lifted essentially all public health measures on July 1. STORY CONTINUES BELOW ADVERTISEMENT
Alberta Health confirmed 279 new COVID-19 cases on Tuesday out of about 5,400 tests. Alberta’s positivity rate sat at around 5.3 per cent. Two additional deaths from COVID-19 were reported to Alberta Health in the last 24 hours. READ MORE: Pediatricians plead for strong COVID-19 measures: ‘Abdication of our responsibility’ Premier Jason Kenney said Monday he remains confident in Alberta’s decision to lift COVID-19 safety measures, despite growing concerns from physicians. The Alberta Medical Association section of pediatrics penned a letter to Kenney expressing grave concern over Alberta’s decision to eliminate COVID-19 testing and tracing, and its plan to end mandated isolation for positive cases on Aug. 16. The group says there is no scientific evidence to support the decision as Alberta battles rising cases, particularly of the highly contagious Delta variant, first identified in India. 4:56‘Potentially we could have a perfect storm’: Dr. Noel Gibney on the Delta variant and back-to-school ‘Potentially we could have a perfect storm’: Dr. Noel Gibney on the Delta variant and back-to-school When asked about the letter, Kenney said his government stands by the advice from Alberta’s chief medical officer of health, Dr. Deena Hinshaw. STORY CONTINUES BELOW ADVERTISEMENT
“It’s hardly a revelation that there is a diversity of views in how best to address the COVID challenge,” Kenney said during an announcement about Alberta’s economy in Edmonton. “We’ve accepted without modification the proposal of the chief medical officer for health, based on the extensive research of our public health officials on the new reality of COVID here in Alberta, and around the world, with the widespread protective effect of vaccines.” 0:56Alberta’s COVID-19 reopening plan was developed by chief medical officer and team: Kenney Alberta’s COVID-19 reopening plan was developed by chief medical officer and team: Kenney – Aug 3, 2021 Close contacts of individuals who test positive for COVID-19 are no longer required to isolate, nor are they notified by contact tracers. Come Aug. 16, infected Albertans will also not be required to quarantine. READ MORE: Hinshaw apologizes for causing ‘fear or anger’ over Alberta’s plan to lift COVID-19 measures Alberta currently has the highest active case count in Canada, followed by British Columbia. STORY CONTINUES BELOW ADVERTISEMENT
As of Tuesday, 76.5 per cent of Albertans 12 and older had received one dose of vaccine, while 67.1 per cent were fully immunized. — with files from Canadian Press
Alberta’s active case rate has been rising for the past couple weeks. On July 14, it was 569, by July 26, it had surpassed 1,000, and Aug. 3, it climbed over 2,100 cases.
4:56‘Potentially we could have a perfect storm’: Dr. Noel Gibney on the Delta variant and back-to-school
0:56Alberta’s COVID-19 reopening plan was developed by chief medical officer and team: Kenney
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