As noted earlier Chile has found Chinese vaccines to be completely worthless. The country followed the right path of getting a large percentage of their population vaccinated, then opening up, only to find the Chinese vaccines they primarily used were completely worthless as COVID spread widely. You would think that a country that was the source of COVID spreading across the world would do a much better job in creating a vaccine. Chile shuts capital Santiago once more as vaccines fail to quell rampant cases https://www.reuters.com/world/ameri...vaccines-fail-quell-rampant-cases-2021-06-10/ Chilean health authorities announced a blanket lockdown across the capital Santiago on Thursday following some of the worst COVID-19 case numbers since the pandemic began, despite having fully vaccinated more than half its population. The development, which will alarm authorities elsewhere who are debating how fast to reopen as vaccination campaigns gather steam, comes as Chile's confirmed daily caseload surged 17% in the past two weeks nationwide and 25% in the Metropolitan region that includes Santiago and is home to half the country's population. Intensive care beds in the capital region are now at 98% capacity. Jose Luis Espinoza, the president of Chile's National Federation of Nursing Associations (FENASENF), said his members were "on the verge of collapse." Chile has one of the world's highest vaccination rates. Around 75% of its 15 million residents have already received at least one dose of vaccine, and nearly 58% are completely inoculated. On a per capita basis among larger countries, it the vaccination leader in the Americas and the fifth highest worldwide, according to Reuters data. It has used nearly 23 million vaccines doses so far - 17.2 million of Sinovac's (SVA.O), 4.6 million of Pfizer (PFE.N) / BioNTech's (22UAy.DE), and less than 1 million each of AstraZeneca's < AZN.L> and CanSino's.(6185.HK) Vaccines are not 100% effective, medical experts pointed out, and there is a time lag before they reach their highest efficacy. Also driving the fierce second wave is lockdown fatigue and the appearance of more contagious variants. Of 7,716 people confirmed as infected with COVID-19 between Wednesday and Thursday, 73% had not been fully inoculated and 74% were under 49 years old, the health ministry said. Dr. Cesar Cortes, emergency physician at the University of Chile hospital, said people who stayed home last year were now more afraid of being without work. "Last year, there was low circulation and the confinement measures were more effective because people were scared of dying," he said. "That's not happening now." Without its vaccines, Chile would be far worse off, he said. "The complicated situation we are seeing now would be catastrophic," he said. Chile's health regulator, the ISP, said genome sequencing of infections between December and June had confirmed the Brazilian P1 variant was the most prevalent in the country, and "twice as contagious as the original strain." Chile is now embarking on vaccinating teenagers, having offered jabs to older age groups. Two weeks ago it introduced green cards to confer greater freedom on the vaccinated in an attempt to encourage the wary to come forward. An infectious disease specialist at a large Santiago hospital, who asked not to be named because he was not authorized to speak officially, said vaccines could not completely relieve the overburdened hospitals. "Around 10% of people, even if they are vaccinated, will not be protected against serious illness. That's hundreds of thousands of people going to ICUs," he said. "And when our health system is strained to the limit as it is now, that percentage alone is enough to overwhelm them."
FDA says 60M J&J vaccine doses from troubled plant must be thrown out https://thehill.com/policy/healthca...-doses-from-troubled-plant-must-be-thrown-out The Food and Drug and Administration (FDA) is forcing Johnson & Johnson to throw out millions of doses of its single-shot COVID-19 vaccine produced at a troubled plant in Baltimore due to contamination concerns. According to The New York Times, 60 million doses were unusable. Another 10 million doses from the plant will be allowed to be distributed but with a warning that the FDA cannot guarantee they were produced using good manufacturing practices, according to the Times. (More at above url)
We already have three vaccines approved in the U.S. under EUA and more doses than we know what to do with. We don't need yet another vaccine approved under EUA. That Bharat Biotech thought the FDA would approve Covaxin without any Phase 3 trail data is absurd on the part of the company. US FDA Denies Emergency Use Approval to Bharat Biotech’s Covaxin Bharat Biotech has announced it will now proceed with an application, seeking full approval for Covaxin in the US. https://www.thequint.com/coronavirus/us-fda-denies-emergency-use-approval-to-bharat-biotechs-covaxin Bharat Biotech's application for emergency use of its COVID-19 vaccine Covaxin in the United States was denied by the US Food and Drugs Administration on Friday, June 11. "With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the USFDA had earlier communicated that no new Emergency Use Authorization (EUA) would be approved for new COVID-19 vaccines (sic)," a statement by the Covaxin manufacturer read. The FDA’s refusal to grant emergency use authorisation to the Indian drugmaker’s vaccine has also been attributed to the lack of data made available on the clinical trials for the vaccine. The Hyderabad-based pharmaceutical company had submitted only partial data of its clinical trials, which excluded its phase-3 trial data, as per a Hindustan Times report. Bharat Biotech has announced that it no longer intends to seek an emergency-use authorisation from the US authority. "The Company will no longer pursue an Emergency Use Authorization for COVAXIN (developed by Bharat Biotech & ICMR) (sic)," its US partner Ocugen said, as per ANI. Rather, it will now proceed with an application, seeking full approval for its COVID-19 vaccine in the US. Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval. All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN. This process will extend our timelines. - Bharat Biotech’s Statement Covaxin has received emergency use authorisation in 14 countries, including Phillipines, Mauritius, and Mexico so far, and is pushing for approval in 50 other nations.
Powerful new COVID-19 vaccine shows 90% efficacy, could boost world's supply https://www.sciencemag.org/news/202...e-shows-90-efficacy-could-boost-worlds-supply The dark-horse vaccine company Novavax announced strong results today from a pivotal, 30,000-person trial of its pandemic coronavirus vaccine in the United States and Mexico. The vaccine uses a protein of SARS-CoV-2, a different technology than the COVID-19 vaccines authorized so far, and delivered 90.4% overall efficacy against symptomatic COVID-19 infections, and 100% protection against moderate and severe disease. Against eight viral variants of interest and concern, its efficacy was 93.2%. And the vaccine appeared safe and well-tolerated. “This vaccine looks phenomenal. I am thrilled about these results,” says Monica Gandhi, an infectious disease physician and epidemiologist at the University of California, San Francisco. She notes that the clinical trial was highly diverse, with 44% non-White participants, and that the vaccine’s straightforward storage requirements could speed access to it in remote communities around the globe. The difference of a few percentage points between Novavax’s 90% efficacy and the 95% and 94% efficacy of the Pfizer/BioNTech and Moderna vaccines is explained in part by Novavax’s later trial, which pitted the vaccine against viral variants, says John Moore, an immunologist at Weill Cornell Medicine and a participant in the Novavax trial. The trials of the other companies' vaccines, composed of messenger RNA (mRNA), were completed before such variants were widely circulating. “This is a vaccine whose efficacy is at least on a par with Pfizer and Moderna,” Moore says. “It’s essentially 100% protective against disease.” One expert is less impressed, however. “The data they have [are] nothing spectacular,” says Vijay Samant, the chief executive officer of Xiconic Pharmaceuticals and a former chief operating officer of Merck’s vaccine division. “The efficacy overall is couple of notches below the Pfizer and Moderna studies…it’s a me-too vaccine at best.” Novavax plans to apply to the U.S. Food and Drug Administration (FDA) and other regulators for an emergency use authorization in the third quarter, once the company completes regulatory requirements aimed at ensuring its product consistently matches the vaccine used in the clinical trials, said president and chief executive officer Stanley Erck. Today’s announcement marks the end of a very long beginning for the once-moribund Gaithersburg, Maryland company, which began developing a vaccine in January, 2020, and in July won $1.6 billion from the U.S. government’s Operation Warp Speed. But the company encountered production problems that delayed the launch of its North American clinical trial until late December 2020. In the trial, two-thirds of participants at 113 sites in the U.S. and 6 sites in Mexico initially received two doses of the vaccine separated by 21 days. One-third of participants received placebo. Between January 25 and April 30, participants experienced 77 cases of COVID-19, 63 of them in the placebo group. All 14 cases in vaccinated participants were mild. These results are similar to those Novavax reported in January from a late-stage trial of more than 15,000 people in the United Kingdom. That trial showed the vaccine efficacy was 89% overall, 86% against the Alpha variant that was first identified in the United Kingdom, and 96% against the original virus strain. But in a separate trial involving 4400 participants in South Africa, where the worrisome Beta variant arose and was circulating widely, the vaccine’s overall efficacy sank to 49%. In the new trial, Novavax sequenced 70% of all the coronaviruses that caused illness. In more than half of the sequenced cases, they found, the culprit was the Alpha variant, which accounted for 70% of U.S. infections by the time Novavax’s trial closed. But the company did not provide specific efficacy data against Alpha or any other variant. (Only two cases of the Beta variant were reported in the trial.) “It doesn’t really address the lingering questions about how well the vaccine would work against ‘escape’ variants” like Beta, says Natalie Dean, a biostatistician at the University of Florida. The COVID-19 vaccines so far authorized by major western regulatory agencies deliver genetic material that directs a recipient’s cells to make spike, a surface protein from SARS-CoV-2, that then trains the immune system to respond to the virus. Novavax’s vaccine instead delivers the spike protein itself, carried on soaplike particles and given extra punch by an immune-boosting substance called an adjuvant. Protein technology has been used for decades in vaccines against diseases including hepatitis B. In clinical trials so far, Novovax’s vaccine has produced somewhat fewer powerful though transient system-wide side effects such as headache, muscle pain, and fatigue, which many recipients of the Pfizer/BioNTech and Moderna vaccines experienced. For instance, 54% of participants who received Moderna’s vaccine as part of a 30,000-person trial reported at least one such effect; in Novavax’s 15,000-person trial in the United Kingdom, that number was 38%. After a second dose of vaccine in the North American Novavax trial, around 40% of participants who received the active vaccine reported experiencing some degree of headache, muscle pain, or fatigue. But serious reactions were rare. Having relatively mild side effects is a plus, says Mayank Mamtani, a biotechnology analyst who follows Novavax for B. Riley Securities. “This Novavax vaccine is going to be less reactogenic. You don’t have to cancel all your meetings” afterwards, he says. He adds that the Novavax jab may find a niche as a booster vaccine in the U.S., where he says such boosters may be needed by October or November. “We in this country love choice,” he adds. Under its 2020 contract with the U.S. government’s Operation Warp Speed, Novavax committed to deliver 110 million doses to the U.S. government, although the U.S. does not need them for initial vaccinations. Novavax expects to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the fourth quarter of 2021, Erck said. The company has advance-purchase orders for about 200 million vaccines from another five western governments and last month signed a deal to supply GAVI, the Global Alliance for Vaccines and Immunizations, with 350 million doses for COVAX, a global vaccine-sharing partnership. The Serum Institute of India, which is also making the Novavax vaccine, is slated to deliver another 750 million doses to COVAX, Novavax says. The Serum Institute plans to start delivering the Novavax vaccine by September this year, providing regulatory agencies have authorized it, officials there told Science. Novavax’s production projections are substantially dialed-back from earlier company predictions that it would ship 2 billion doses in 2021. That reflects the company’s struggle to scale up its manufacturing both at its own facilities and those of contractors and partner companies in 11 nations. “Novavax has been particularly challenged with executing on production scale-up efforts and manufacturing,” Mamtani wrote in a note to investment clients last month. Unlike mRNA vaccines, which need to be stored frozen, Novavax’s protein vaccine can be stored in a refrigerator for up to six months, and, once removed, remains viable for 24 hours. Novavax has created a new version of its vaccine, adapted to the Beta variant, that could be used as a one-year booster, the company says. On Friday, it announced positive results for the adapted vaccine in mice and baboons. Novavax says it is also working to customize its vaccine to other variants. But Samant cautions that Novavax’s manufacturing struggles and the entrenched advantages of companies whose vaccines were approved months ago may make the small company’s climb to market share and profitability a tough one.
Novavax coming though looking to be really effective, including some data with some of the more virulent strains of Covid. What’s nice about this is it is more of a traditional vaccine in that the methodology is already in use for things pertussis, hepatitis b and flu vaccines. It can also be easily stored in a regular refrigerator and is generally a shot that can be administered in a common doctors office. The convenience of this vaccine is really where it can help. https://news.yahoo.com/novavax-large-study-finds-covid-100450049.html
In the U.S. they gave out free donuts if you were vaccinated. In the Philippines you get a cow. Philippines offering free cow to those who sign up for COVID vaccine https://nypost.com/2021/06/14/philippines-offering-free-cow-to-those-who-sign-up-for-covid-vaccine/
The EU regulators desperately want vaccines created in the region -- even if they have nearly no efficacy. An efficacy below 50% basically means the vaccine is worthless -- but the EU regulators will consider it nevertheless. EU regulator will weigh COVID-19 vaccine candidates with below 50% efficacy The FDA had also established a 50% efficacy threshold for authorization of COVID-19 vaccines https://www.foxnews.com/health/eu-regulator-covid-19-vaccine-candidates-50-efficacy-threshold A top official with Europe’s regulatory agency on Thursday said it would weigh COVID-19 vaccines for approval despite the efficacy potentially falling below a 50% threshold. The comments from Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at the European Medicines Agency follow news that German biotech CureVac’s COVID-19 mRNA vaccine candidate revealed a disappointing 47% efficacy against COVID-19 disease of any severity, and failed to meet statistical success criteria in a late-stage trial. However, Dr. Franz-Werner Haas, CEO of CureVac, said "the overall vaccine efficacy may change" as the company proceeds toward a final analysis. "With respect to the 50% threshold, we were asking in agreement with the other regulators that the studies are designed in a way that they could prove that the efficacy is at least 50% but we made clear right from the start this does not mean that we will not look into the entirety of the evidence," Cavaleri said during a press briefing Thursday. "We will consider the benefits and the risks demonstrated by the vaccine and come out with a decision on whether such a vaccine could be approved or not." The U.S. FDA had also established a 50% efficacy threshold for authorization of COVID-19 vaccines. During a conference call Thursday, the CureVac CEO attributed the low efficacy to a "dramatically transformed variant environment, suggesting that we are virtually fighting a different virus and a different pandemic over the last six months." The low efficacy comes in contrast to Pfizer and Moderna's mRNA COVID-19 vaccines with over 90% efficacy and only somewhat diminished protection in the face of viral variants.
Yet another example showing the Chinese vaccines are worthless... Hundreds of vaccinated Indonesian health workers get COVID-19, dozens in hospital https://www.reuters.com/world/asia-...vid-19-despite-vaccination-dozens-2021-06-17/ More than 350 doctors and medical workers have caught COVID-19 in Indonesia despite being vaccinated with Sinovac and dozens have been hospitalised, officials said, as concerns grow about the efficacy of some vaccines against more infectious variants. Most of the workers were asymptomatic and self-isolating at home, said Badai Ismoyo, head of the health office in the district of Kudus in central Java, but dozens were in hospital with high fevers and falling oxygen-saturation levels. Kudus, which has about 5,000 healthcare workers, is battling an outbreak believed to be driven by the more transmissible Delta variant, which has raised its bed occupancy rates above 90%. Designated as a priority group, healthcare workers were among the first to be vaccinated when inoculations began in January. Almost all have received the COVID-19 vaccine developed by Chinese biopharmaceutical company Sinovac, the Indonesian Medical Association (IDI) says. While the number of Indonesian healthcare workers dying from COVID-19 has dropped sharply from 158 in January to 13 in May, according to data initiative group LaporCOVID-19, public health experts say the Java hospitalisations are cause for concern. "The data shows they have the Delta variant (in Kudus) so it is no surprise that the breakthrough infection is higher than before, because, as we know, the majority of healthcare workers in Indonesia got Sinovac, and we still don’t know yet how effective it is in the real world against the Delta variant,” said Dicky Budiman, an epidemiologist at Australia's Griffith University. A spokesperson from Sinovac was not immediately available for comment on the efficacy of the Chinese firm's CoronaVac against newer variants of the virus. The World Health Organization (WHO) approved emergency use of Sinovac's vaccine this month, saying results showed it prevented symptomatic disease in 51% of recipients and prevented severe COVID-19 and hospital stays. read more As Indonesia grappled with one of Asia's worst outbreaks, with over 1.9 million infections and 53,000 deaths, its doctors and nurses have suffered a heavy toll of 946 deaths. Many are now experiencing pandemic fatigue and taking a less vigilant approach to health protocols after being vaccinated, said Lenny Ekawati, from the independent health-linked data group LaporCOVID-19. Across Indonesia, at least five doctors and one nurse have died from COVID-19 despite being vaccinated, according to LaporCOVID-19, although one had only received a first shot. Siti Nadia Tarmizi, a senior health ministry official, did not immediately respond to a request for comment on how many doctors have died since the vaccination program began. In Kudus, one senior doctor has died, said IDI. Nadia said there had been no deaths in Kudus since a new outbreak began in the past several weeks among medical workers and that those who contracted COVID-19 have had mild symptoms. In Jakarta, the capital, radiologist Dr Prijo Sidipratomo told Reuters he knew of at least half a dozen doctors hospitalised with COVID-19 in the past month despite being vaccinated, with one now being treated in an ICU. "It is alarming for us because we cannot rely on vaccinations only," he said, urging people to take precautions. Weeks after the Muslim Eid Al-Fitr holidays, Indonesia has experienced a surge in cases, with the positivity rate exceeding 23% on Wednesday and daily cases nearing 10,000, its highest since late February. In its latest report, the WHO urged Indonesia to tighten its lockdown amid increased transmission and a surge in bed occupancy rates.
Well if a cow does not tempt you.... how about what the Netherlands is offering... Netherlands offers free herring as Covid jab incentive Country becomes the latest to encourage uptake by offering a traditional early-summer delicacy https://www.theguardian.com/world/2...s-free-pickled-herring-as-covid-jab-incentive
Cuba decided to make its own COVID-19 vaccines. Now it needs syringes https://www.miamiherald.com/news/nation-world/world/americas/cuba/article252183433.html Cuba, which says it has developed fiveCOVID-19 vaccinecandidates and immunized about 2 million people in the island of 11 million, apparently didn’t plan for a crucial part of its vaccination campaign: syringes. As COVID-19 cases have spiked in recent weeks, the lack of syringes looms as a major challenge for the island, where acrushing recessionhas triggered a food crisis and shortages of medicine and basic necessities. Trump-era sanctions made it harder for Cuba to buy syringes from major manufacturers, which are already swamped with orders from bigger, richer countries. Making matters worse, some of Cuba’s vaccines require three doses, meaning the Caribbean nation needs more syringes per capita than most countries using the double shots made by Pfizer, Astrazeneca, Moderna and the single-dose jab by Janssen. Cuba is aiming to vaccinate all of Havana’s 2 million population by September and a total of about 10 million people by the end of the year. When it became clear the island wouldn’t manage on its own, aid organizations in the U.S. and Europe sprang into action. Theylaunched campaignsto collect donations to buy syringes and have them shipped to the island to help narrow a deficit of as many as 25 million syringes. The response in just little over a month has been “phenomenal,” according to Global Health Partners, a New York-based NGO that’s leading the Saving Lives campaign. Others in Spain, Italy and Latin American nations like Argentina and Honduras have also contributed. Cubans living abroad launched campaigns in cities all over the world, and in Miami a caravan against the U.S. embargo last month also collected local donations. “I’ve been doing medical aid campaigns to help Cuba for over 20 years and I’ve never seen anything like this,” said executive director Bob Schwartz. He said the organization was initially targeting enough money to buy 3 million syringes, but got such overwhelming support — and $400,000 in donations — that it purchased 4 million and is working to buy another 2 million. He hopes to have them on the ground in Cuba by mid-July. Global Health Partners has a U.S. Commerce Department license to send medical supplies to Cuba. It’s unclear how many syringes Cuba has or needs, but official state media have publicized donations the island has received from countries like France and Argentina. The island managed to navigate the first waves of the coronavirus pandemic last year thanks to a strict quarantine and a public health system that, although hit by severe shortages in recent years, remains stronger than its counterparts in many of its Caribbean neighbors. But a new wave after Cuba reopened its borders to tourism in November has placed the island near the top of COVID-19 rankings in the region, triggering calls for the government to start mass vaccinations. Health officials began administering the Soberana and Abdala shots last month even before they were approved by Cuba’s drug authority. COVID-19 cases, which totaled just over 12,200 in all of last year, surpassed 149,000 so far this year. Since the start of the pandemic Cuba has registered about 162,000 cases and 1,118 deaths, according to the World Health Organization. The island hit a record 1,537 new cases on Tuesday before the numbers fell slightly to 1,403 on Wednesday. Cuban government officials were criticized for not purchasing vaccines to start protecting its population sooner, while it worked on developing its own shots. The socialist regime opted to focus on a homegrown solution that is presumably cheaper and can ensure a provision of lifesaving shots even amid challenges created by the long-standing U.S. embargo. Cuba’s long tradition of vaccine production, a robust biotech industry and critical mass of scientists set it up for success in becoming the first country in Latin America to produce a COVID vaccine. The island has five vaccines in various stages of clinical trials and aims to produce around 100 million doses this year to export to countries in Latin America and Africa. It has even flagged the possibility of offering vaccines to tourists. And production can continue over the next few years to supply a likely need of booster shots. But for now, it needs syringes for its own people. Vaccinations in Havana have slowed transmission there, with infection rates falling to around 370 from a peak of about 800 per day a month ago, according to government data. The improvement is partly due to vaccination efforts, said the Heath Ministry’s director of epidemiology, Francisco Durán García, in a daily televised update on Wednesday. “We need to continue to advance as fast as we can so that we can see what effect [the vaccine] will have, together with prevention measures that the population already knows,” he said. One group in Miami wants the Cuban American community to contribute to help families on the island get vaccinated. The Caravan for the Cuban Family and the Lifting of the Blockade of Cuba, which has attracted dozens of supporters in cars and bikes to different Miami locations on the last Sunday of every month since July last year, is spreading the word about how people can donate to the syringe efforts, said Carlos Lazo, one of the organizers. “A lot of people in Miami have family in Cuba, and I’m sure they want their families protected from COVID-19; joining the campaign for syringes is a huge way to help them,” Lasso said. A caravan is scheduled for Sunday, June 20, departing at 9 a.m. from Ponce de Leon Park in Coral Gables.