FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization https://www.cnn.com/2021/02/24/health/johnson-vaccine-fda-analysis/index.html In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization. The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single dose vaccination and 66.1% at least 28 days after vaccination, a new analysis meant to brief the FDA's Vaccines and Related Biological Products Advisory Committee said. "There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," the analysis said. In a briefing document, the FDA said that it has reviewed the data for the vaccine and has determined that it is "consistent with the recommendations set forth in FDA's guidance Emergency Use Authorization for Vaccines to Prevent COVID-19." An independent group of FDA advisers, the Vaccines and related Biological Products Advisory Committee, will consider the documents and make a recommendation about whether the Covid-19 vaccination should be authorized. The committee meets on Friday.
India sends first vaccine doses to Africa under WHO's COVAX programme https://www.reuters.com/article/health-coronavirus-india-who-idUSKBN2AN1MV India will on Tuesday make its first shipment of a locally made COVID-19 shot to the WHO-backed equitable vaccine distribution network COVAX, the government said. “Fulfilling our commitment to help the world with COVID-19 vaccines, supplies of Made-in-India vaccine commence today for Africa under COVAX facility,” Anurag Srivastava, spokesman for the Ministry of External Affairs, said on Twitter. The World Health Organization this month paved the way for the Oxford University/AstraZeneca vaccine’s global roll-out by approving emergency use of the product produced by the Serum Institute of India (SII), the world’s biggest vaccine maker, and SK Bioscience of South Korea. SII will also soon start producing the Novavax vaccine mainly for poor and middle-income countries. India, the world’s biggest maker of vaccines, has shipped over 17 million vaccine doses to more than two dozen countries - including around 6 million as gifts to partners such as Bangladesh and Nepal. For its own campaign, New Delhi has so far only ordered 31 million doses.
Great explainer on the science of how the J&J vaccine works here (really good info): https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html
Despite surveys claiming up to 30% of people would reject the COVID vaccine -- the actual vaccine acceptance being seen is actually very high. Just 2% in Spain refuse coronavirus vaccine, COVID-19 incidence declining https://www.reuters.com/article/us-health-coronavirus-spain-idUSKBN2AP2P3 Just over 2% of Spaniards offered a coronavirus vaccine have rejected it, including people who avoided the shot for medical reasons, the Health Ministry said on Thursday, as the nation’s overall infection rate continued to decline. “They are really positive data,” senior health official Silvia Calzon told reporters at a news conference. “This demonstrates the acceptance and confidence that the whole of Spanish society has in vaccination.” As of Wednesday, a total of 45,611 people had chosen not to take the vaccine, while about 2.1 million people from priority groups such as nursing home residents and staff, people over age 80 and frontline medics, have taken a shot. Some 1.2 million people have received a full course of two shots. Spain’s two-week incidence of the virus fell to 206 cases per 100,000 people on Thursday, down from almost 900 cases at the end of January. The steep descent prompted Health Emergency Chief Fernando Simon to raise the possibility that some restrictions would be lifted in the coming days, though he stressed that pressure on hospitals remains fairly high. Asked about the Madrid regional government’s decision to allow marches of up to 500 people to mark the International Women’s Day on March 8, he said it was better to avoid large groups where possible. The Health Ministry reported 9,568 cases on Thursday, bringing the total to 3.18 million, while the COVID-19 death toll rose by 345 to 68,468.
A third Pfizer dose? The Covid-19 vaccine maker is studying booster shots. Pfizer CEO Albert Bourla spoke with NBC News' Lester Holt about the next steps for the company's Covid-19 vaccine. https://www.nbcnews.com/health/heal...vaccine-maker-studying-booster-shots-n1258775 Despite the 95 percent effectiveness at preventing coronavirus infection after two doses of its vaccine, Pfizer is now seeing what a third dose might do. The company announced Thursday that a booster dose is being studied among people who received their first doses of the vaccine more than six months ago. In an interview with NBC News' Lester Holt, Pfizer CEO Albert Bourla said the hope is that a third dose will boost the immune response even higher, offering better protection against variants. "We believe that the third dose," Bourla said, "will raise the antibody response 10- to 20- fold." The new study will monitor the safety and efficacy of a third dose in two age groups: those 18 to 55 and those 65 to 85. The participants come from a group of people who were among the first to receive the Pfizer-BioNTech vaccine: people who volunteered for Pfizer's initial Phase 1/2 clinical trial, which began in May. During that trial, participants received two doses of the vaccine three weeks apart. The same dose interval is what's currently recommended. The third shot will be exactly the same as what participants got a year ago. Pfizer also plans to begin testing whether a modified version of the vaccine works well against the variant from South Africa. Indeed, as SARS-CoV-2 changes, the vaccines may have to be tweaked. The Food and Drug Administration issued guidance Monday saying vaccine manufacturers may be able to ease away from lengthy clinical trials to prove safety and effectiveness for vaccines that have been tweaked to account for variants. That's not unlike how the flu shot changes from year to year, accounting for the strains most likely to infect people. "Every year, you need to go to get your flu vaccine," Bourla said. "It's going to be the same with Covid. In a year, you will have to go and get your annual shot for Covid to be protected." That suggests that even when the pandemic ends, Covid-19 may be here to stay. Ongoing studies of re-engineered vaccines are necessary to understand when boosters may be needed, outside experts said. "You need to cast a wide net to find Goldilocks," said John Grabenstein, a former executive director of medical affairs for vaccines at Merck and a former Defense Department immunologist. "You want to look at shorter intervals, you want to look at longer intervals, to determine when is the best time, if needed, to re-vaccinate." So far, evidence suggests that the existing Pfizer-BioNTech vaccine remains effective against variants first identified in the U.K., Brazil and South Africa. Bourla said the company's goal if and when another variant emerges is to pivot and tweak the current vaccine within 100 days. Moderna, which makes a similar Covid-19 vaccine, announced Wednesday that it had also started studying the effects of adding a third dose to its regimen and has developed a version of the vaccine designed to target the variant from South Africa.
It would raise the sales with 50%. It is all about making money and milking the pandemic as much as possible.
Many of their stocks double, triple or quadruple and then they get paid hundreds of millions of dollars from world governments to produce vaccines... Milking the Pandemic is an understatement. The world is giving them a blowjob. wrbtrader
Covid vaccines may stop spread ‘almost completely’ with jabs working ‘better than any of us could have imagined’ Fresh boost for Britain as vaccines appear to block virus transmission https://www.standard.co.uk/news/health/covid-vaccine-results-public-health-england-b921793.html
This would be great news if it pans out. Saying it does, with the disparity in vaccination rates across the globe, it’s going to become very important to know how long vaccinated “immunity” lasts.