The F.D.A. releases stricter guidelines for vaccine developers after a holdup at the White House. https://www.nytimes.com/live/2020/1...-developers-after-a-holdup-at-the-white-house The Food and Drug Administration released updated, stricter guidelines on Tuesday for coronavirus vaccine developers — a step that was blocked for two weeks by top White House officials. The guidelines make it highly unlikely that a vaccine could be authorized by Election Day. The move, which was cleared by the Office of Management and Budget, appeared to be an abrupt reversal a day after The New York Times reported that White House officials, including Mark Meadows, the chief of staff, were blocking the guidelines. The new guidelines recommend gathering extra data about the safety of vaccines in the final stage of clinical trials, a step that would take more time. Since the start of the coronavirus pandemic, the F.D.A. has said that it has been seeking ways to accelerate the development of vaccines without sacrificing safety. In June, the agency released an initial set of guidelines to give vaccine developers a better idea of how the F.D.A. would decide if a vaccine were acceptable, either for an emergency use authorization or for a full license. Four vaccines have reached the final stage of testing, known as a Phase 3 trial, in the United States. A fifth is expected to start this month. President Trump has repeatedly suggested that a vaccine would be ready by Election Day, if not before. But with public confidence declining in opinion polls about what could be a rushed coronavirus vaccine, the F.D.A. submitted a new set of guidelines to the White House for approval on Sept. 21. Among the recommendations, the agency advised vaccine makers to follow volunteers for a median of two months after the final dose. The F.D.A. also expected vaccine makers to document five cases of severe infection in people who received the placebo instead of the vaccine. The F.D.A. submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in part because of Mr. Meadows’s involvement, according to a senior administration official and others familiar with the situation. The White House objected that the guidelines would add more time before a vaccine could be authorized. In a conversation with Dr. Stephen M. Hahn, the Food and Drug Administration commissioner, days after the guidelines were submitted, Mr. Meadows said the recommendations amounted to changing the rules on drugmakers in the throes of clinical trials, according to one senior administration official. He also suggested that Dr. Hahn was overly influenced by career scientists, who had drafted the document, the official said. Trump administration officials have the authority to intervene with such nonbinding documents, partly because of a 2019 executive order that tightened restrictions over their issuance. The F.D.A., however, continued to share parts of this guidance with vaccine developers in response to questions they submitted to the agency. “We’ve made it clear that we want to see a median of about two months of follow-up for any of the vaccines that comes in,” Dr. Peter Marks, the F.D.A.’s top regulator for vaccines, said in an interview on YouTube on Friday. On Tuesday, the F.D.A. published the guidelines at the end of a document the F.D.A. prepared for the meeting on Oct. 22 of the Vaccines and Related Biological Products Advisory Committee. The committee will be discussing the development, authorization and licensing of Covid vaccines. In a statement Tuesday, the drug industry’s largest trade group, the Pharmaceutical Research and Manufacturers of America, said it supported “any efforts by F.D.A. to provide clarifying guidance.” “We have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines,” the statement said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”
Inhaled Vaccines Aim to Fight Coronavirus at Its Point of Attack Vaccines sprayed into the nose or inhaled through the mouth won’t require needles and could be easier to roll out. They may be more effective too. https://www.bloomberg.com/news/arti...accines-may-be-more-effective-than-injections The Covid-19 vaccines closest to the finish line are designed to be injected into the arm. Researchers are looking at whether they can get better protection from inoculations that fight the virus at its point of attack — the nose and mouth. Most vaccines in human testing require two shots for effectiveness, and developers still aren’t even sure if they’ll prevent infections. Scientists are hoping to generate superior immune responses with inhaled vaccines that directly target the airway cells the virus invades. An alternative to conventional jabs, sprayed and inhaled immunizations under development in the U.S., Britain and Hong Kong could play an important role in helping society escape restrictions that have upended economies and everyday life. Among their goals is to prevent the pathogen from growing in the nose, a point from which it can spread to the rest of the body, and to other people. “Local immunity matters,” said Frances Lund, a University of Alabama at Birmingham immunologist working with biotech Altimmune Inc. on an early-stage nasal inoculation. “The vaccines that can be delivered to generate that will have some advantages over vaccines that are delivered systemically.” Most early vaccine developers focused on a familiar route — injections — seen as the fastest to protecting the world from disease. Inhaled vaccine makers are counting on some of the unique features of the lungs, nose and throat, which are lined with mucosa. This tissue contains high levels of immune proteins, called IgA, that give better protection against respiratory viruses. Read More: Dual Flu-Covid Nasal Spray Vaccine to Start Trial in Hong Kong Activating these immune weapons, they theorize, can protect areas deeper in the lungs where the SARS-CoV-2 does the most damage. They also may improve vaccines’ chances of blocking transmission. “The first generation of vaccines are probably going to protect a lot of people,” said Michael Diamond, an infectious disease specialist at Washington University in St. Louis. “But I think it’s the second- and third-generation vaccines — and maybe intranasal vaccines will be a key component of this — that ultimately are going to be necessary. Otherwise, we’ll continue to have community transmission.” In a study of mice in August, Diamond and his team found that delivering an experimental vaccine via the nose created a strong immune response throughout the body; the approach was especially effective in the nose and respiratory tract, preventing infection from taking hold. India’s Bharat Biotech and St. Louis-based Precision Virologics last month obtained rights to the single-dose technology. Vaccines that are sprayed into the nose or inhaled may hold other practical benefits. They don’t require needles, may not need to be stored and shipped at low temperatures and can reduce the need for health workers to administer them. “When you’re thinking about trying to deliver that across the world, if you don’t need to have an injectable vaccine, your compliance goes up because people don’t like getting shots,” according to Lund, the Alabama-based researcher. “But secondly, the level of expertise needed to administer that vaccine is significantly different.” Read More: Second-Generation Covid Vaccines Are Built for Impact Over Speed Altimmune, based in Gaithersburg, Maryland, plans to enter human testing with a nasal vaccine in the fourth quarter after positive studies in mice. Scientists at the University of Oxford, where a promising shot under development at AstraZeneca Plc was designed, and Imperial College London are also planning studies of slightly different inhaled vaccines. The experimental immunizations in Britain would be delivered through a mouthpiece in an aerosol, similar to some asthma therapies. Imperial researchers point to evidence that delivering influenza vaccines via a nasal spray can protect people against illness and help reduce transmission; they’re keen to explore if that’s also the case for SARS-CoV-2. AstraZeneca makes the FluMist nasal spray vaccine. Data from studies of the inhaled Oxford vaccine could come early in the new year, followed by Imperial results in the second quarter, according to Robin Shattock, an infectious disease specialist at Imperial College. “We don’t know whether it will work well, but if it does, then it could be very important,” he said in an interview. Imperial College in recent months has been advancing studies of a Covid vaccine using RNA technology that would be delivered via conventional shots and plans to expand its trials to 20,000 people by year-end. Oxford, one of the front-runners in the global quest for an inoculation, is in the final stage of tests for a shot that uses a harmless virus to carry the genetic material of the pathogen into cells to generate an immune response. Both techniques may be conducive to inhalation, Shattock said. “This is a virus that’s transmitted through your respiratory tract, so if you want a vaccine that will really prevent infection and onward transmission you want to have an antibody response in your nose, in your lungs,” Shattock said. “The most efficient way to induce that is by inoculating through that route.” Read More: After Vaccine Sprint Would Come Distribution Slog Researchers in Hong Kong are aiming for an intranasal vaccine that would simultaneously offer influenza and Covid-19 protection. The first phase of human tests will start next month, said Yuen Kwok-Yung, chair of infectious diseases in the University of Hong Kong’s department of microbiology. The ambition is to come up with the “vaccine of choice,” as the world looks to build on the first wave of products, he said. Questions about the durability of nasal vaccines have yet to be resolved, and they’re at an early stage. Despite the advantages, the delivery devices are also more complex, according to Nick Jackson, head of programs and technology at the Coalition for Epidemic Preparedness Innovations. “A needle and syringe work very well,” he said. Still, researchers said targeting the airways may pay off down the road. Oslo-based CEPI has provided funding to the Hong Kong project and is open to further investments in vaccines that are taking unconventional approaches as part of an effort to supply billions of doses to every corner of the world, Jackson said. “Whether it’s our vaccine or another one that goes through an intransasal route that actually is successful at disrupting transmission and disrupting the pandemic, I take my hat off,” Diamond said. “If we contribute by compelling or nudging these companies to think about an alternative route for what may be a successful platform, then we’ve done our job.”
There will be bumps on the road on the way to a safe, effective, proven vaccine for COVID. J&J just hit a significant speed bump. Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant https://www.cnbc.com/2020/10/12/joh...ue-to-unexplained-illness-in-participant.html The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant. A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT. Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details. “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement. J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses. The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo. Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19. Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said. “If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.” On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. Johnson and Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.
Ahhh, couple days to clear things up probably. Or until the end of the week. J and J says they don't even know whether the patient was in the placebo group or vaccine receiving group yet, although that might have changed by now. Saw that in the Financial Times and Wall Street Journal too. It's in the hands of the government Medical Review Board. These guys are playing by the rules which builds them a lot of cred with the FDA and those who want to argue that Trump just interferes with everything.
However each situation like this -- causing the trial to be paused -- sets them back at least 2 to 3 weeks.
Indeed, but does it set them back against their plan projection? I don't know. Surely they must have planned for two or three pauses along the way. I don't know. And then they may be playing to a larger game plan which is that by being ultra-religious about pausing on every blip that that will give them the cred to get expedited approval for the drug such that net net it shortens the time.
Covid-19: FDA approves Pfizer vaccine trials in teenagers and children as young as 12 The drugmaker confirmed that there are already parents interested to enroll their kids in the inoculation program. https://www.ibtimes.co.uk/coronaviu...ne-trials-teenagers-children-young-12-1684555 With several COVID-19 vaccine trials drawing to a close, many are already projecting a positive outlook in the next few months. Majority of the subjects tested are healthy adults and the results recorded show no signs of alarming side effects. Now, Pfizer announced plans to use its experimental jabs on children as young as 12 years. The pharmaceutical group confirms that they have already secured approval from the Food and Drug Administration (FDA). The drugmaker confirmed that there are already parents interested to enroll their kids in the inoculation programme. Once testing begins, it will be the United States' first COVID-19 vaccine trial that involves kids. Cincinnati Children's Hospital Vaccine Research Center director Dr. Robert Frenck shares details about the process. Pfizer's clinical trials will start with teenagers aged 16 and 17 later this week. Those in the 12 to 15-years age bracket will follow soon thereafter, reports CNN. "We really think a vaccine for adolescents and children is going to be critical for getting Covid under control," according to Frenck. "I think one of the things that is important to remember is that although the death rate for children with Covid is lower than in older adults, it's not zero." "Most of the time in kids, you have a young kid at home and they have a runny nose, they have a cough -- you are not going to bring them to a doctor," he noted. "And most of the time, what a coronavirus causes is a cold." Experts believe there are more children infected by the 2019 novel coronavirus but might have been inaccurately presented in published reports. This is likely due to how symptoms develop in younger patients. Therefore, there is a likelihood that children can unintentionally spread SARS-CoV-2 to folks who are more susceptible to severe symptoms after infection. These include health workers, parents, grandparents, and other children as well. Pfizer is developing the vaccine together with BioNTech. So far, among those who were given the jab, major complaints only include pain within the injection area, fever, headaches, and chills among others. Meanwhile, blood samples taken from volunteers reportedly show the presence of antibodies that would fight against the infection.
Remdisivir seems not to work according to the WHO https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1 METHODS Study drugs were Remdesivir, Hydroxychloroquine, Lopinavir (fixed-dose combination with Ritonavir) and Interferon-β1a (mainly subcutaneous; initially with Lopinavir, later not). This was the conclusion about the 4 products: No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalisation duration. CONCLUSIONS These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay. The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.
China's Covid-19 vax is safe, prompts antibody response By IANS On October 16 , 2020 | UPDATED 12:19 IST Chinese Covid-19 vaccine candidate -- BBIBP-CorV -- that is expected to completely inactivate the SARS-CoV-2 virus, is safe and elicits an antibody response, a study published in The Lancet has found. A previous clinical trial reported similar results for a different vaccine that is also based on inactivated whole SARS-CoV-2 virus, but in that study the vaccine was only tested on people aged under 60 years. The latest study reported in The Lancet Infectious Diseases journal included participants aged between 18 and 80 years, and found that antibody responses were induced in all recipients. Participants aged 60 and over were slower to respond, taking 42 days before antibodies were detected in all recipients compared with 28 days for participants aged 18-59. "Protecting older people is a key aim of a successful Covid-19 vaccine as this age group is at greater risk of severe illness from the disease," said study author Xiaoming Yang from the Beijing Institute of Biological Products Company Limited in China. However, vaccines are sometimes less effective in this group because the immune system weakens with age. "It is therefore encouraging to see that BBIBP-CorV induces antibody responses in people aged 60 and older, and we believe this justifies further investigation," Yang added. The BBIBP-CorV vaccine used in the study reported here is based on a sample of the virus that was isolated from a patient in China. Stocks of the virus were grown in the lab using cell lines and then inactivated using a chemical called beta-proprionolactone. BBIBP-CorV includes the killed virus mixed with another component, aluminium hydroxide, which is called an adjuvant because it is known to boost immune responses. The first phase of the study was designed to find the optimal safe dose for BBIBP-CorV. It involved 96 healthy volunteers aged between 18 and 59 years and a second group of 96 participants aged between 60 years and 80 years. Within each group, the vaccine was tested at three different dose levels, with two vaccinations administered on day zero and 28. A fourth group within each age group (24 participants in each age group) were given two doses of a placebo vaccine. In total, in phase 1 of the study, 144 participants received the vaccine and 48 received the placebo. The second phase of the study was designed to identify the optimal timing schedule for vaccination. Participants were asked to report any adverse events for the first seven days after each vaccination and these were verified by the research team. "No serious adverse events were reported within 28 days of the final vaccination. There were no instances of clinically significant changes in organ functions detected in laboratory tests in any of the groups," the authors wrote. https://www.greatandhra.com/article...-vax-is-safe-prompts-antibody-response-108211
It should be noted the manufacturer of Remdisivir,Gilead Sciences, only commits that the average hospital stay is shorter by 4 days. Gilead has plenty for peer-reviewed, multi-randomized studies to back their assertions at this point. This is what they had to say in response (in the BBC article). Gilead Sciences Inc dismissed the findings. "The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomised, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir," the company said in a statement. "We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design." BBC article - https://tinyurl.com/y4l3jp3t