As expected... follow-up from AstraZeneca... COVID-19: AstraZeneca defends vaccine trial data against US claims of possible 'outdated information' https://uk.news.yahoo.com/covid-19-astrazeneca-defends-vaccine-213300580.html AstraZeneca has defended its use of coronavirus vaccine data after US authorities suggested some results from a large American-led trial may have been based on "outdated information". The Anglo-Swedish company said the study showed the jab was 79% effective in preventing symptomatic COVID-19 illness and 100% effective against severe disease and hospitalisation. The trial of 30,000 people showed no serious side effects, according to details released on Monday. An independent safety monitor also found no increased risk of blood clots - something that caused European countries to temporarily stop using the vaccine until recently. But a day after the release of the trial's findings, concerns have been raised that AstraZeneca may have given an incomplete view of the data. The US National Institute of Allergy and Infectious Diseases said the Data and Safety Monitoring Board (DSMB) had "expressed concern that AstraZeneca may have included outdated information... which may have provided an incomplete view of the efficacy data". "We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible," a statement said. AstraZeneca has said it will publish up-to-date results from the trial in 48 hours. It said: "The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of February 17." The company added it had "reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis". "We are now completing the validation of the statistical analysis," it continued. "We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data." America is still to approve the AstraZeneca jab, with the final decision to be made by the Food and Drug Administration (FDA) and Centres for Disease Control and Prevention (CDC). The top US infectious diseases expert, Dr Anthony Fauci, said on Tuesday that the vaccine is still "very likely a very good vaccine". He told Good Morning America: "If you look at it, the data really are quite good but when they [AstraZeneca] put it into the press release it wasn't completely accurate." Dr Fauci explained: "When the data from the AZ trial that was conducted predominately in the United States was analysed by the DSMB together with the company, what happened is that the company put out a press release giving data and making some conclusions about the efficacy. "And the data safety monitoring board when they saw that press release, they got concerned and wrote a rather harsh note to them that was copied to me, saying that in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit and wanted them to straighten it out." Professor Stephen Evans, from London School of Hygiene and Tropical Medicine, said he was not "concerned particularly" about the DSMB statement "unless they had found a safety issue that was being hidden, which does not appear to be the case". Dr Peter English, a retired consultant in communicable disease control, criticised the US statement as leaving "room for speculation which could be damaging for vaccine uptake". More than a dozen European countries recently paused using the jab over fears it may have caused blood clots but a review by the EU regulator found it was safe and cleared it for continued use, with several EU nations resuming its rollout. The World Health Organisation also insisted it was safe. The vaccine, co-developed with Oxford University, has been a mainstay of the UK's vaccine effort.
Interesting commentary about multiple countries including the Green Passes being used in Israel for the vaccinated. Vaccine roll-out: How does Ireland compare to other countries? https://www.rte.ie/news/primetime/2...ines-how-ireland-compares-to-other-countries/ What will Ireland look like when the majority of the country is inoculated? It's a question that will be asked over the coming months as the rate of vaccination ramps up across the spring and into summer. So far, around 10% of people in the country have received one vaccine dose. And 3.7% have received a second dose. A blueprint for how we might live exists in Israel. They've given a first dose of the vaccine to 60% of the population, and two doses to over 53%. With the country emerging out of lockdown, Israel now operates a Green Pass system. It means people who are vaccinated carry a certificate to confirm they have received two doses, either in the form of a sheet of paper or a phone app with a QR code. The pass is valid for six months, effective the week after receiving the second dose. Daniel Rosehill, originally from Cork, now lives in Jerusalem. Since receiving his Green Pass, Daniel has been enjoying freedoms like the gym, swimming pools, bars, restaurants and hotels. They all require a Green Pass to enter. "It shows, basically, that you've had your doses. It shows what type of vaccine you had, what date you had your doses," Daniel told Prime Time. "When you go into a gym or a bar, there is someone checking for your Green Pass. So far, they've been pretty strict across all the places I've been." Daniel regularly travels by train or bus to Tel Aviv, where mask-wearing is still essential on public transport and in taxis. He told Prime Time that many young people flock to Tel Aviv for its nightlife, but the roll-out has been trickier with this cohort. Some regions are trying to incentivise them to get vaccinated. "In Tel Aviv, some of the bars were doing a shot-for-shot campaign where you'd get a shot of alcohol in exchange for getting the vaccine," Daniel said. In January, Covid-19 was surging through South Africa, with cases at almost 22,000 per day. But, despite fears about the variant first seen in South Africa, also known as B1351, cases have steadily fallen in recent months to around 1,000 cases per day. The decline has confounded experts, since it was achieved without a stringent lockdown. The country's vaccine roll-out has also been slow. In February, South Africa suspended its use of the AstraZeneca vaccine after it showed a low level of efficacy against mild and moderate cases of the variant. Last week, the country's health ministry said it had sold on its unused AstraZeneca doses to other African Union member states. They had aimed to vaccinate 1.5 million people by the end of April, but that has since been revised to 500,000. The government has now ordered nine million doses of the single-shot Johnson & Johnson vaccine. Despite international concern about the South African variant, Tyrone native Sean Campbell said that the panic had subsided in Cape Town, where he is based. "For the time being, the government has lifted most restrictions. By day, particularly on the weekends, people are out and about," Sean said. "A lot of South Africans have commented how they have read about the variant more in the international media. When it first emerged, there was quite a bit of fear, but we pretty quickly realised that the same measures were going to help deal with it. We just had to be extremely careful." In France, a new lockdown came into effect last Friday after a rise in Covid cases threatened to overwhelm the ICUs of Paris hospitals. While Mandy Cherie from Donegal is confined to her apartment, many other Parisians made a break for the countryside. "Every time the government announces there's going to be a lockdown, there's always a mass exodus from Paris," she said, noting that many would have secondary residences outside of the city. The lockdown comes against the backdrop of a slow vaccination roll-out in France. Around 9% of the population have had their first jab, while the AstraZeneca vaccine is only being administered to over-55s. There is a lot of scepticism about the vaccination programme in France, partly because of how quickly regulators approved the vaccines, Mandy noted. "Culturally the French are very sceptical, so a lot of people are waiting to see the results of the vaccine abroad before they take it themselves," she said. While non-essential retail outlets have once again been shut, the list of essential stores that can remain open includes bookshops, music stores, hairdressers, florists and chocolate shops. People are also allowed outside, provided they stay within a 10km radius. In Denmark, the government plans to lift restrictions once all over-50s have been vaccinated. Businesses, sports and cultural attractions will be allowed to reopen in stages throughout April and May. The country will also introduce vaccine passports, which will be required in some instances. So far, authorities in Denmark have administered one dose to around 11% of the population. Chris Gallagher, from Coolock, now lives in Holme-Olstrup, 80km south of Copenhagen. "The restrictions are still quite tight, but they hope to have everyone vaccinated by the end of July. The Danes have been very disciplined. They've really listened to the government," Chris told Prime Time. "Not everyone agrees with it, but people have come together – and they've really followed the main goals of the government." The Danish roll-out has been boosted by the country's digital healthcare system, which allows people like Chris to access their medical history online and receive messages directly from medical professionals. Those administering the vaccine roll-out use the system to determine which cohorts of the population should receive a jab first. "Everything is logged into this database, so they know everything about every individual's health in the country," Chris said. "So they can pinpoint exactly who will need the vaccination first."
Study says Covid-19 vaccines provide protection for pregnant and lactating women -- and their newborns https://www.cnn.com/2021/03/25/health/pregnant-women-covid-19-vaccines-study-wellness/index.html The Pfizer/BioNTech and Moderna Covid-19 vaccines are effective in pregnant and lactating women, who can pass protective antibodies to newborns, according to research published Thursday in the American Journal of Obstetrics and Gynecology. Researchers at Massachusetts General Hospital, Brigham and Women's Hospital and the Ragon Institute of MGH, MIT and Harvard looked at 131 women who received either the Pfizer/BioNTech or Moderna Covid-19 vaccine. Among the participants, 84 were pregnant, 31 were lactating and 16 were not pregnant. Samples were collected between December 17, 2020 and March 2, 2021. The vaccine-induced antibody levels were equivalent in pregnant and lactating women, compared to non-pregnant women. The antibody levels were "strikingly higher" than those resulting from coronavirus infection during pregnancy, the team noted. "These vaccines seem to work incredibly effectively in these women," said one of the researchers, Galit Alter, a professor of medicine at the Ragon Institute. In addition, the team found that women passed protective antibodies to their newborns, measured in breast milk and the placenta. "Nearly all the moms were getting a pretty decent level of antibodies to their babies," said Alter, who added that additional research is needed to understand how long those protective antibodies last in newborns. Participants used the US Centers for Disease Control and Prevention's V-safe tool, which allows people who have received a Covid-19 vaccine to track their reaction. Alter said they found no evidence of more side effects or more intense side effects in pregnant and lactating women than in the general population. While the team found similar antibody levels in women vaccinated with both vaccines, Alter said they found higher levels of IgA antibodies in pregnant women who received the Moderna vaccine. She said this particular type of antibody may be transferred more efficiently to babies, for a longer period of time. "There is some reason to think that having higher levels of IgA immunity might be more protective," Alter noted. She said additional research into this finding could help inform policy decisions about which vaccines are used for pregnant populations. Recent research similarly found that mRNA vaccines illicit antibodies in pregnant women that can be transferred to their babies, though this is the largest study on vaccines in pregnant women, to date. Pregnant and lactating women were not included in the initial clinical trials of the vaccines. With no data to look to help inform pregnant women's decisions about getting vaccinated against Covid-19, Alter said researchers and new and expectant mothers -- particularly health care workers -- stepped up to fill the void. "MGH and Brigham started to talk to the health care workers that were eligible for vaccination, that were also pregnant, and they created a study to empower pregnant women with the ability to track their responses, but to also develop data that could essentially help the entire globe approach vaccination and pregnancy for the first time in this collective kind of way. "It was really just a force to be reckoned with, both from the OB-GYN/provider perspective, but also from the community," said Alter. "It was inspiring." According to the CDC, pregnant people with Covid-19 are at increased risk for severe illness and may be at increased risk for adverse outcomes, like preterm birth. The CDC says it hopes to study vaccine safety in around 13,000 pregnant people for each of the three authorized coronavirus vaccines. The agency will use a specific V-safe pregnancy registry, which had enrolled about 3,612 pregnant women, as of March 22. "This is an urgent need, because we're not only protecting one person in this vaccine effort, we're protecting two people at the same time," said Alter.
Pfizer's first COVID shot for children administered at Duke https://www.wral.com/coronavirus/pf...t-for-children-administered-at-duke/19594271/ The so-called City of Medicine helped launch Pfizer's effort to protect the world's children from COVID-19. The pharmaceutical company on Wednesday launched Phase 1 of its study into how its COVID vaccine will affect children under the age of 12. Twin 9-year-old girls, Alejandra and Marisol Gerardo, were at Duke Health in Durham when they received the first vaccinations in the United States. The study's principal investigator is Dr. Emmanuel “Chip” Walter, chief medical officer of the Duke Human Vaccine Institute. He emphasized the importance of protecting children from the novel coronavirus. “First, children can develop serious infection and the consequences of infection include death,” Walter said. “There have been more deaths in children during the past year than during a typical flu season. Second, being able to vaccinate children is an important component of developing herd immunity, or population-level protection, as children makeup a significant proportion of our population.” Three hospitals in other states are also participating in the trial, in which 48 children will receive three different dosage levels of the vaccine. Their reactions will help determine how the study proceeds to its second phase.
Rutgers University announced Thursday that it will require COVID-19 vaccines for all on-campus students who are enrolled for the 2021 fall semester. Thoughts?
We will see this trend for most U.S. universities. A university does not want the liability of a large crowded student population widely spreading COVID across campus and then be sued over deaths & hospitalizations due to it. Nor can universities afford to do what Duke did to keep students safe — which included required Covid tests every week and other expensive measures. The best thing for a university to do in order to have everyone back on campus is to require a Covid vaccination and not take any other measures. I will note that back when I went to college they required submission of vaccination for many diseases in order to attend (MMR, etc.).
Yes but you know how people are in this country... as soon as you tell them they have to do something, the anger and refusal explodes. There are people refusing to take the vaccine simply because they are being told to get it. One asshat said why get the vaccine if you can still get COVID.... Iw as like seriously?? You get the flu shot and you can still get the flu but because of the shot you can greatly reduce the effects and duration of it... People claim science and then come up with stuff that is so far from science so if universities try this, i say the tell parents if they dont like it transfer or show a medical note.
Yep... a university can easily expel you if you refuse to follow their rules. If you don't like the COVID vaccine policy of your university then I am sure you can transfer to some university founded on religious principles (such as Liberty) which will not require vaccination.
You have to get immunizations when you go to college now. It’s just another shot. I don’t see this as a big deal. The reckoning will come with employers.