Boosters provide the best protection against Omicron variant, CDC studies show, raising new questions about what it means to be fully vaccinated https://www.cnn.com/2022/01/21/health/cdc-omicron-booster-studies/index.html Three large new studies from the US Centers for Disease Control and Prevention highlight the importance of getting a booster shot to provide the best protection against the Omicron coronavirus variant. This is the first real-life data to examine the effect of boosters against Omicron, which now accounts for more than 99% of coronavirus cases in the United States. The studies, released Friday, raise the question of whether people with just two vaccine doses should still be considered fully vaccinated. "I think we have to redefine fully vaccinated as three doses," said Dr. William Schaffner, a longtime CDC vaccine adviser who was not involved with the studies. The studies have an enormous scope, involving millions of cases, hundreds of thousands of visits to emergency departments and urgent care centers, and tens of thousands of hospitalizations among adults. Getting boosted was 90% effective at preventing hospitalizations during a period in December and January when Omicron was the dominant variant, according to a CDC study that looked at nearly 88,000 hospitalizations across 10 states. In comparison, getting two shots was 57% effective when it had been at least six months past the second shot. Getting boosted was 82% effective at preventing visits to emergency rooms and urgent care centers, according to the study, which looked at more than 200,000 visits in 10 states. In comparison, getting two shots was only 38% effective at preventing those visits when it had been at least six months past the second shot. "I think it's the third dose that really gives you the solid, the very best protection," Schaffner said. That study was published Friday in the CDC's Morbidity and Mortality Weekly Report. A second study, also published in Friday's MMWR, concluded that people with three shots were less likely to get infected with Omicron. Looking at data from 25 state and local health departments, the CDC researchers found that among those who were boosted, there were 149 cases per 100,000 people on average each week. For those who had only two doses, it was 255 cases per 100,000 people. A third study, to be published in the medical journal JAMA, showed that having a booster helped prevent people from becoming ill with Omicron. That study of just over 13,000 US Omicron cases found that the odds of developing a symptomatic infection were 66% lower for people who were boosted compared to those who had only received two shots. All three studies found that unvaccinated people faced the highest risks of becoming sick with Covid-19. The CDC currently says a person is considered fully vaccinated after they've received their primary Covid-19 vaccines -- two weeks after receiving their second dose of an mRNA vaccine, or two weeks after their first dose of the Johnson & Johnson vaccine. Booster doses are recommended for everyone age 12 and older five months after their primary vaccination series. Less than half of those eligible to receive booster shots have gotten one, and only about a quarter of the total US population is fully vaccinated and boosted, according to CDC data. Nearly 20% of the US population eligible to be vaccinated -- those age 5 and older -- has not received any dose of Covid-19 vaccine.
CDC: Unvaccinated seniors 50 times more likely to be hospitalized than those with boosters https://thehill.com/policy/healthca...mes-more-likely-to-be-hospitalized-than-those
When omicron was first identified in late November and began spreading rapidly in the United States, millions of vaccinated people lined up for the extra shots. But that has slowed. To date, 39 percent of fully vaccinated people have gotten the additional doses, according to the CDC.
One chart shows how well vaccines and boosters protect against severe Omicron compared to Delta https://www.businessinsider.com/how-well-do-boosters-vaccines-protect-omicron-chart-2022-1 Booster shots appear to be at least 90% effective against hospitalization for Delta and Omicron. But Omicron poses a greater challenge to vaccine protection, according to three new CDC studies. Omicron increased the odds that vaccinated or boosted people would get infected relative to Delta. COVID-19 booster shots were effective at preventing hospitalization and death before Omicron started spreading in the US. But protection from a third dose is essential now that Omicron cases are predominate, according to three new studies from the Centers for Disease Control and Prevention. The first CDC study looked at severe cases of COVID-19 among adults in 10 states from August to mid-December 2021, when the Delta variant was dominant, and from mid-December 2021 to January 2022, when Omicron started to take over. During that time, the CDC's Vision Network recorded around 88,000 hospitalizations for COVID-19. Adults who received an mRNA booster saw the highest protection during both the Delta and Omicron periods: Boosters reduced the risk of hospitalization by at least 90%. But two mRNA doses were far less effective at preventing severe Omicron cases than severe Delta ones, the study found. The chart below shows how well vaccines protected against hospitalization during the Omicron and Delta periods. During the Delta period, the effectiveness of a second dose waned slightly after about 26 weeks — from 90% to 81%. A third dose brought that protection back up to 94%. But protection significantly declined during the Omicron period: A second dose was 81% effective against hospitalization after 2-26 weeks, but just 57% effective after 26 weeks. Booster shots increased that protection to 90%. Separately, the study also examined nearly 223,000 COVID-19-related visits to emergency departments or urgent care clinics from August 2021 to January 2022. Overall, booster shots reduced the risk of someone winding up in these settings, but protection was higher before mid-December. During the Delta period, booster shots reduced the risk of a COVID-19-related visit to the emergency department or urgent care clinic by 94% two weeks after they were administered. During the Omicron period, boosters reduced the risk of those visits by 82%. The findings nevertheless "underscore the importance of receiving a third dose" to prevent moderate and severe COVID-19, the researchers wrote.
Pfizer CEO sees annual COVID vaccine rather than frequent boosters https://www.reuters.com/business/he...ine-rather-than-frequent-boosters-2022-01-22/ Pfizer Inc (PFE.N) Chief Executive Albert Bourla said on Saturday that an annual COVID-19 vaccine would be preferable to more frequent booster shots in fighting the coronavirus pandemic. Pfizer/BioNtech's (22UAy.DE )COVID-19 vaccine has shown to be effective against severe disease and death caused by the heavily-mutated Omicron variant but less effective in preventing transmission. With cases soaring, some countries have expanded COVID-19 vaccine booster programmes or shortened the gap between shots as governments scramble to shore up protection. read more In an interview with Israel's N12 News, Bourla was asked whether he sees booster shots being administered every four to five months on a regular basis. "This will not be a good scenario. What I'm hoping (is) that we will have a vaccine that you will have to do once a year," Bourla said. "Once a year - it is easier to convince people to do it. It is easier for people to remember. "So from a public health perspective, it is an ideal situation. We are looking to see if we can create a vaccine that covers Omicron and doesn't forget the other variants and that could be a solution," Bourla said. Bourla has said Pfizer could be ready to file for approval for a redesigned vaccine to fight Omicron, and mass produce it, as soon as March. Citing three studies, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday that a third dose of an mRNA vaccine is key to fighting Omicron, providing 90% protection against hospitalization. A preliminary study published by Israel's Sheba Medical Center on Monday found that a fourth shot increases antibodies to even higher levels than the third but was likely not enough to fend off Omicron. Nonetheless, a second booster was still advised for risk groups, Sheba said.
Seems like the issue for FDA Approval in the outpatient setting was the insurance companies...not the FDA. In addition, the below quote is a little concerning involving "skilled staff"... ---------- For the remdesivir treatment, patients must go to a clinic or hospital three days in a row, which may be difficult for some people. And the drug must be administered by skilled staff, which can present a logistical challenge as many hospitals are hobbled by personnel shortages. ---------- I wonder how does a patient get remdesivir treatment by a "skilled staff" in an outpatient environment (e.g. clinic, doctor's office) ??? This implies doctor's offices and clinics outside the hospital will have a difficult task in hiring new employees or training current employees to treat Covid ill patients but it does make sense in that many patients are more likely to seek early medical care with their personal doctor instead of going to the hospital. On the flip side, outpatient care is typically more problematic because they usually do appointments only in comparison to a hospital (emergency care) that's typically 24/7. I'm interested to see how this plays out in FDA-approved "outpatient" remdesivir treatment. wrbtrader
Editorials Covid-19 vaccines and treatments: we must have raw data, now BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o102 (Published 19 January 2022) Cite this as: BMJ 2022;376102 Data should be fully and immediately available for public scrutiny In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.1234 The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data.56 Public battles for drug company data,78 transparency campaigns with thousands of signatures,910 strengthened journal data sharing requirements,1112 explicit commitments from companies to share data,13 new data access website portals,8 and landmark transparency policies from medicines regulators1415 all promised a new era in data transparency. Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions. Unacceptable delay Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728). The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data “may be available … with publication of the final study results in 2022.”18 Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427). As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”20 Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.” We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny. Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process. In the words of the European Medicine Agency’s former executive director and senior medical officer, “relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea ... Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).”22 Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.23 This month, however, a judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. The data are to be made available on the requesting organisation’s website (phmpt.org). In releasing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves acknowledgment.2425 Until recently, however, the data remained of limited utility, with copious redactions aimed at protecting trial blinding. But study reports with fewer redactions have been available since September 2021,2425 and missing appendices may be accessible through freedom of information requests. Even so, anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data, and it remains to be seen how the FDA responds to the court order. Moreover, the FDA is producing data only for Pfizer’s vaccine; other manufacturers’ data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers. Like the FDA, and unlike its Canadian and European counterparts, the UK’s regulator—the Medicines and Healthcare Products Regulatory Agency—does not proactively release clinical trial documents, and it has also stopped posting information released in response to freedom of information requests on its website.26 Transparency and trust As well as access to the underlying data, transparent decision making is essential. Regulators and public health bodies could release details27 such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2.28 Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.29 Big pharma is the least trusted industry.30 At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.31 One pleaded guilty to fraud.31 Other companies have no pre-covid track record. Now the covid pandemic has minted many new pharma billionaires, and vaccine manufacturers have reported tens of billions in revenue.32 The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use. Twelve years ago we called for the immediate release of raw data from clinical trials.1 We reiterate that call now. Data must be available when trial results are announced, published, or used to justify regulatory decisions. There is no place for wholesale exemptions from good practice during a pandemic. The public has paid for covid-19 vaccines through vast public funding of research, and it is the public that takes on the balance of benefits and harms that accompany vaccination. The public, therefore, has a right and entitlement to those data, as well as to the interrogation of those data by experts. Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.33 The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.