MIT study finds COVID vaccines 'significantly associated' with jump in emergency heart problems COVID-19 vaccination was "significantly associated" with a 25% jump in emergency medical services (EMS) for heart problems in 16-39 year-olds in Israel, whose vaccination rate is among the world's highest, according to a peer-reviewed study by MIT researchers. Published last week in the Nature journal Scientific Reports, the study found no association with COVID infections, however. "While not establishing causal relationships, the findings raise concerns regarding vaccine-induced undetected severe cardiovascular side-effects and underscore the already established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals," the study says. The research adds more fuel to the legal and grassroots campaigns against compelled vaccination. An Italian administrative court deemed a vaccine mandate on nursing students unconstitutional, citing nearly 10,000 reported deaths from various COVID vaccines in the European Medicines Agency's EudraVigilance monitoring system, but referred the case to the country's Constitutional Court. (The new MIT study also mentions EudraVigilance.) Published in late March, the 53-page ruling only drew attention in the U.S. last week when an anti-vaccine mandate group translated a portion. Just the News ran the ruling through Google Translate, which said in part the reported death count exceeds the "normal and, therefore, tolerable" risk permitted under vaccine mandates. File Italian-court-ruling-vaccine-mandate.pdf Meanwhile, American Airlines pilot Robert Snow blamed his cardiac arrest six minutes after landing a 200-passenger flight April 9 on his compelled vaccination in November. "I will probably never fly again" due to FAA health criteria for pilots, he said in a video from the ICU in Dallas. "This is the actual result of the vaccine for some of us." Anti-mandate pilot group U.S. Freedom Flyers accused the Federal Aviation Administration of turning a blind eye to the risks of adverse events from COVID vaccines, both to pilots jabbed against their will and crew and passengers on their flights. The FAA didn't answer Just the News on whether it's investigating the Snow incident, and if not, how it differs from other health-related incidents it would investigate, but pointed to an FAQ on COVID vaccines for pilots and air traffic controllers. "The FAA's Federal Air Surgeon determined in December 2020 and February 2021 that pilots and air traffic controllers can safely receive the Pfizer, Moderna, or Johnson & Johnson vaccine," the agency said in a prepared statement. "The FAA has seen no evidence of aircraft accidents or pilot incapacitations caused by pilots suffering medical complications associated with COVID-19 vaccines." U.S. Freedom Flyers is "informally" collecting adverse event reports from pilots and working with doctors, statisticians and scientists to come up with good estimates of their frequency, cofounder Joshua Yoder told Just the News Tuesday. "We know we have a major problem on our hands" quantifying the problem. Yoder recently told the Vaccine Safety Research Center that cardiologist Peter McCullough, formerly vice chief of internal medicine at Baylor University Medical Center, told him around 30% of pilots would be sidelined if they were screened for vaccine-induced heart conditions with McCullough's recommended protocol. The MIT study's corresponding author is management professor Retsef Levi, also a member of Israel's Public Emergency Council for the Coronavirus Crisis. He and McCullough both spoke at the Academy for Science and Freedom inaugural conference on censorship in science in March. The study notes Israel's Ministry of Health has already assessed a myocarditis risk in 16-24 year-old males of between 1 in 3,000 and 1 in 6,000 after the second mRNA dose, and 1 in 120,000 for under-30 males. The study analyzed calls to the Israel National EMS data system from Jan. 1, 2019 through June 20, 2021. This represents a 14-month "normal period" before the pandemic, 10-month pre-vaccination, dual-wave "pandemic period," and six months of vaccination. The breakdown shows how cardiac arrest (CA) and acute coronary syndrome (ACS) calls, confirmed on site by first responders, "change over time with different background conditions and potentially highlight factors that are associated with the observed temporal changes." Researchers excluded CA calls related to trauma, overdose or suicide, and the protocols were the same for the full 30-month study period, "allowing for a consistent comparison between the call counts during the baseline, pandemic, and vaccination periods." The vaccine rollout period for 16-39 year-olds, January-May 2021, coincided with the third COVID wave in Israel. It showed a "statistically significant increase of over 25%" for both kinds of calls compared to the same period in 2020. For CA specifically, there was "no statistically significant difference in the respective call volume" between full-year 2019 and 2020. For ACS, the "significant relevant increase" in that full-year period (15.8%) was outpaced by the January-May 2021 increase (26%). The researchers said the January 2021 increase "seems to track closely the administration of 2nd dose vaccines," while a second observed increase starting April 18 "seems to track an increase of single-dose vaccination to individuals who recovered from COVID-19 infections." (The Israel Ministry of Health approved the latter for ages 16 and up in early March 2021.) Females unexpectedly had a higher jump in calls: 31% for CA and 41% for ACS, compared to increases for males of 25% CA and 21% ACS. This may indicate a "potential underdiagnosis or under-self-reporting of myocarditis in females," according to the study, which was exempt from review by MIT's Institutional Review Board. https://justthenews.com/politics-policy/coronavirus/mit-study-finds-covid-vaccines-significantly-associated-jump-emergency
This article about a local mRNA Covid vaccine is from Thailand. The FDA in this article refers to the federal drug agency in Thailand, not the U.S. First lot of local Covid vaccine produced Chula researchers say jab more effective than Pfizer, approval possible by year-end https://www.bangkokpost.com/thailand/general/2306270/first-lot-of-local-covid-vaccine-produced The first batch of ChulaCov19, the first messenger-RNA vaccine developed in Thailand, has been produced and is awaiting Food and Drug Administration (FDA) approval for the first two phases of human trials, a government spokesperson said on Saturday. The first lot of the Covid-19 vaccine developed by Chulalongkorn University researchers was produced by Thailand-based BioNet-Asia Co Ltd. If all trial results meet the requirements, the vaccine is expected to be registered for use by the end of this year, deputy government spokeswoman Rachada Dhnadirek said. According to the Chula Vaccine Research Center, ChulaCov19 is safe and has a higher efficacy than the Pfizer BioNTech vaccine against the coronavirus. The Pfizer vaccine has an efficacy of 95% against symptomatic SARS-CoV-2 infection. Production of the vaccine was supported by 2.31 billion baht in funding approved by the cabinet in November last year. “The government wants Thailand to be a country capable of creating, conducting research and development and producing its own vaccine, which is in accordance with its 10-year strategic plan to become a medical hub (by 2026),” Ms Rachada said. “The goal was set before the Covid-19 pandemic began, and by becoming a vaccine production centre, more Thai people will have access to the vaccine.” Ms Rachada said ChulaCov19 had passed two preliminary stages of trials on volunteers, with lab results showing safe, effective responses to the virus. “The antibodies generated by ChulaCov19 were higher than from Pfizer vaccines used in Thailand,” she said, quoting the Chula Vaccine Research Centre. Thailand will pursue domestic production of the vaccine in the next phase of the project, she added.
Duke University is working on a new oral Covid-19 vaccine. New oral COVID-19 vaccine can prevent disease and transmission https://knowridge.com/2022/05/new-oral-covid-19-vaccine-can-prevent-disease-and-transmission/ Scientists from Duke University found a new COVID vaccine designed to be taken orally not only protects the host, but also decreases the airborne spread of the virus to other close contacts. They demonstrated the potential of a COVID vaccine that works through the mucosal tissue to neutralize the SARS-CoV-2 virus, limiting infections and the spread of the active virus in airborne particles. The research is published in Science Translational Medicine and was conducted by Stephanie N. Langel et al. Considering most of the world is under-immunized—and this is especially true of children—the possibility that a vaccinated person with a breakthrough infection can spread COVID to unimmunized family or community members poses a public health risk. There would be a substantial benefit to developing vaccines that not only protect against disease but also reduce transmission to unvaccinated people. In the study, the team tested a vaccine candidate that uses an adenovirus as a vector to express the spike protein of the SARS-CoV-2 virus. The human vaccine is designed to be taken as a pill. The team found in hamsters, the vaccine elicited a robust antibody response in blood and the lungs. When the animals were exposed to the SARS-CoV-2 virus at high levels, prompting breakthrough infections, they were less symptomatic than non-vaccinated hamsters, had lower amounts of infectious virus in the nose and lungs. Because of this, they did not shed as much virus through normal airborne exposures. Unlike vaccines that are injected into the muscle, mucosal immunizations increase the production of immunoglobulin A (IgA)—the immune system’s first line of defense against pathogens—in the nose and lungs. These mucosal ports of entry are then protected, making it less likely that those who are vaccinated will transmit infectious virus during a sneeze or cough. The findings demonstrate that mucosal immunization is a viable strategy to decrease the spread of COVID through airborne transmission. The study focused on the original SARS-CoV-2 virus, and new studies will be designed to test the vaccine against Omicron variants.
No funding, well no next generation Covid vaccine for you then... U.S. will limit next-generation Covid vaccines to high-risk people this fall if Congress doesn’t approve more funding https://www.cnbc.com/2022/05/09/us-...-if-congress-doesnt-approve-more-funding.html The White House has warned that it does not have enough money to buy next-generation Covid vaccines for all Americans ahead of a possible fall infection wave. If Congress fails to pass additional funding, the U.S. will have to limit the updated Covid shots to individuals at the highest risk of severe disease, a senior administration official said. Pfizer and Moderna are developing shots that target the mutations of the omicron variant to boost protection against infection. The U.S. will have to limit the next generation of Covid vaccines this fall to individuals at the highest risk of getting seriously sick from the virus if Congress fails to approve funding to purchase the new shots, according to a senior Biden administration official. The official, who spoke on condition of anonymity, warned the U.S. faces a substantial surge of Covid infections this fall as immunity from the current vaccines wanes and the omicron variant mutates into more transmissible subvariants. The U.S. needs more money for next-generation vaccines, therapeutics and tests to prevent infections from turning into hospitalizations and deaths, the official said. Pfizer and Moderna are developing redesigned vaccines that target the omicron variant’s mutations to boost protection against infection. The current shots are still targeting the original virus strain that first emerged in Wuhan, China, in 2019. As the virus has evolved over the past two years, the vaccines have become less effective at preventing mild illness, though they generally still protect against severe disease. The Food and Drug Administration is expected to make a decision by early summer at the latest on whether the U.S. should switch to the redesigned shots for a fall vaccination campaign, with its advisory committee set to hold a meeting on June 28 to discuss the issue. However, the U.S. currently does not have enough money to purchase the new shots for everybody in the U.S. ahead of the fall, the official said. The U.S. Senate has failed so far to pass $10 billion in additional Covid funding for vaccines, therapeutics and testing despite Senate Majority Leader Chuck Schumer, D-N.Y., and Sen Mitt Romney, R-Utah, striking a deal in early April. The $10 billion Senate deal is less than half the $22.5 billion the White House originally requested. “We will be able to get some vaccines of the new generation but it’ll be a very limited amount and really only for the highest-risk individuals, but it will not be available for everybody,” the official said. The elderly and people with weak immune systems are the highest risk of severe illness from Covid. Congress needs to pass funding within the next few weeks to ensure that contract negotiations between the federal government and the vaccine makers are in an advanced stage by July, the official said. However, Republicans in the Senate have vowed to block the money unless the White House reinstates Title 42, which allowed the U.S. to turn away asylum seekers at the nation’s borders during the pandemic. Even if the money comes through, it’s unclear if the vaccine makers can produce enough shots for the fall given how short the timeline is. Moderna CEO Stephane Bancel told CNBC last week it’s a tight turnaround for any biotech company to have tens of millions of doses ready for the fall if they don’t order supplies and start production before July . “If you look at the timelines, I don’t think any manufacturer will be able to be ready in August to fill the channel with product,” Bancel told CNBC’s Meg Tirrell. The U.S. government’s last contract for Covid vaccines with Moderna ended in April. Pfizer CEO Albert Bourla told CNBC last week that the pharmaceutical giant would be ready to start manufacturing doses of its next-generation vaccine as soon as it receives guidance from the FDA. The U.S. also needs more money for testing to ensure that the nation has enough capacity for the fall, the administration official said, warning that domestic manufacturers are shutting down production lines now. Without funding, the U.S. would be dependent on test manufacturers in other nations, particularly China, the official said. “It’s going to be a pretty tough fall and winter if Congress abdicates its responsibilities and does not show up with funding for the American people,” the official said. “We’re going to do what we can but at th