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Corona Virus Vaccines

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Public health experts urge Americans to not skip 2nd vaccine dose​

NEW YORK - The United States is now averaging more than 3 million vaccine shots every day. Even as the program is accelerating, new cases are stubbornly still on the rise.

Side effects coming with the second dose of the Moderna and Pfizer vaccines have increased so-called vaccine hesitancy. Some people are even hoping to get away with just one shot. But the National Institutes of Health is warning against stopping at one dose.

"When you just leave it at one dose, the question is, how long does it last?" Dr. Anthony Fauci, the director of NIAID, said. "And when you're dealing with variants, you're in a tenuous zone."
 

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Are the two countries comparable?

Israel’s case has a key difference to that of Chile’s in that it has exclusively administered Pfizer/BioNTech vaccine, whereas Chile is using Pfizer/BioNTech and Sinovac Biotech shots. It is unclear what difference, if any, that may have, but the Pfizer/BioNTech vaccine has been one of the strongest performers in clinical trials. Other differences between the countries – with vastly different societies and demographics, and possibly different virus variants in circulation – can also make comparisons misleading.
 

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The picture below looked pretty much the same where I am at, they would line you up 40 per and march a line in every 15 minutes.


Army’s own vaccine that could fight COVID variants begins clinical trials​

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A unique vaccine produced by the Walter Reed Army Institute of Research started clinical testing Tuesday, and Army researchers hope it will combat variants of SARS-COV-2, the novel coronavirus that causes COVID-19.

The vaccine, called spike ferritin nanoparticle, or SpFN, could also help fight other coronaviruses, a group of related RNA viruses that often cause respiratory-related diseases in mammals.

Army researchers have been tracking the threat posed by new coronaviruses even before the pandemic, according to Kayvon Modjarrad, director of emerging infectious diseases at Walter Reed. That threat has been accelerating in recent years.

“That’s why we need a vaccine like this: one that has potential to protect broadly and proactively against multiple coronavirus species and strains,” Modjarrad said in a statement announcing the SpFN testing.

The Defense Department has had a combined total of more than 271,000 COVID-19 cases. Of those, 3,814 people have been hospitalized and 332 people have died. Twenty-four of the dead have been service members and 11 have been dependents.

Vaccines produced by Pfizer and Moderna were approved under an emergency use authorization by the U.S. Food and Drug Administration and are available to troops.

The Pentagon has made vaccinating the force a readiness issue so that military operations can return to pre-pandemic norms. Though there was some trouble in lobbying troops to take the voluntary vaccine early on, vaccination rates appear to be rising in recent weeks.
 

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There is more of the story at the link


Pfizer requests FDA clearance for vaccine in kids ages 12 to 15​

The FDA's review process will probably take several weeks, experts say. The move would make Pfizer's vaccine available to the widest age range.

Pfizer on Friday requested to expand use of its Covid-19 vaccine to adolescents ages 12 to 15.

The request asks the Food and Drug Administration to amend the emergency use authorization, which the FDA originally granted late last year for people ages 16 and up.

Last week, Pfizer-BioNTech said its Phase 3 clinical trials showed its vaccine was safe and 100 percent effective in 12- to 15-year-olds, though the findings have not been peer-reviewed.

"The hope of starting to vaccinate this age group before the start of the next school year," CEO Albert Bourla said in a statement when those results were released.
 

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Official: Chinese vaccines’ effectiveness low​

BEIJING (AP) — In a rare admission of the weakness of Chinese coronavirus vaccines, the country’s top disease control official says their effectiveness is low and the government is considering mixing them to get a boost.

Chinese vaccines “don’t have very high protection rates,” said the director of the China Centers for Disease Control, Gao Fu, at a conference Saturday in the southwestern city of Chengdu.

Beijing has distributed hundreds of millions of doses abroad while trying to promote doubt about the effectiveness of the Pfizer-BioNTech vaccine made using the previously experimental messenger RNA, or mRNA, process.

“It’s now under formal consideration whether we should use different vaccines from different technical lines for the immunization process,” Gao said.

Officials at a news conference Sunday didn’t respond directly to questions about Gao’s comment or possible changes in official plans. But another CDC official said developers are working on mRNA-based vaccines.

Gao did not respond to a phone call requesting further comment.

“The mRNA vaccines developed in our country have also entered the clinical trial stage,” said the official, Wang Huaqing. He gave no timeline for possible use.

Experts say mixing vaccines, or sequential immunization, might boost effectiveness. Researchers in Britain are studying a possible combination of Pfizer-BioNTech and the traditional AstraZeneca vaccine.

The coronavirus pandemic, which began in central China in late 2019, marks the first time the Chinese drug industry has played a role in responding to a global health emergency.

Vaccines made by Sinovac, a private company, and Sinopharm, a state-owned firm, have made up the majority of Chinese vaccines distributed to several dozen countries including Mexico, Turkey, Indonesia, Hungary, Brazil and Turkey.

The effectiveness of a Sinovac vaccine at preventing symptomatic infections was found to be as low as 50.4% by researchers in Brazil, near the 50% threshold at which health experts say a vaccine is useful. By comparison, the Pfizer-BioNTech vaccine has been found to be 97% effective.

Health experts say Chinese vaccines are unlikely to be sold to the United States, Western Europe and Japan due to the complexity of the approval process.

A Sinovac spokesman, Liu Peicheng, acknowledged varying levels of effectiveness have been found but said that can be due to the age of people in a study, the strain of virus and other factors.

Beijing has yet to approve any foreign vaccines for use in China.

Gao gave no details of possible changes in strategy but cited mRNA as a possibility.

“Everyone should consider the benefits mRNA vaccines can bring for humanity,” Gao said. “We must follow it carefully and not ignore it just because we already have several types of vaccines already.”

Gao previously questioned the safety of mRNA vaccines. He was quoted by the official Xinhua News Agency as saying in December he couldn’t rule out negative side effects because they were being used for the first time on healthy people.

Chinese state media and popular health and science blogs also have questioned the safety and effectiveness of the Pfizer-BioNTech vaccine.

As of April 2, some 34 million people in China have received both of the two doses required for Chinese vaccines and about 65 million received one, according to Gao.

The Sinovac spokesman, Liu, said studies find protection “may be better” if time between vaccinations is longer than the current 14 days but gave no indication that might be made standard practice.

___

Wu reported from Taipei.
 

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Israeli data shows South African variant able to ‘break through’ Pfizer vaccine​

Strain is more effective than original COVID and the British variant at bypassing the shot, Israeli scientists find, in first-of-its-kind, real-world study​

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The South African variant of the coronavirus is notably more adept at “breaking through” the Pfizer-BioNTech vaccine than other variants are, Israeli scientists have found, in a first-of-its-kind real-world study.

Israel has used the Pfizer vaccine almost exclusively to vaccinate millions of citizens, with a version by Moderna, based on similar innovative mRNA technology, used minimally.

A team from Tel Aviv University and the Clalit healthcare organization sequenced the swabs of 150 Israelis who tested positive for COVID-19 despite having been vaccinated.

In their study, the prevalence of the South African strain among vaccinated individuals who were infected despite their inoculation was eight times higher than its prevalence in the unvaccinated infected population. Though the number of such infections among the vaccinated was relatively small, the findings indicated that this variant was far more successful in getting through vaccinated individuals’ defenses than other strains.

“Based on patterns in the general population, we would have expected just one case of the South African variant, but we saw eight,” Prof. Adi Stern, who headed the research, told The Times of Israel. “Obviously, this result didn’t make me happy.”

She said that the results show that the South African variant, compared to the original strain and the British variant, “is able to break through the vaccine’s protection.” However, she said that the sample size is too small to put a figure on its increased ability.

“We can say it’s less effective, but more research is needed to establish exactly how much,” she said.

Prof. Ran Balicer, director of research at Clalit, said the study was “very important.”

“It is the first in the world to be based on real-world data, showing that the vaccine is less effective against the South African variant, compared to both the original virus and the British variant,” he said.

Balicer added that the results call for continued vigilance against the coronavirus, including social distancing and wearing masks in indoor spaces, to prevent infection.

“These preliminary findings necessitates close continued attention to the dissemination of this strain in Israel, emphasizing the need for epidemiological monitoring and systematic sequencing, in order to contain further spread of the South African variant in Israel,” he said.

The research, which has been posted online but not yet peer-reviewed, is likely to raise questions about Pfizer’s own real-world study, which found that in South Africa, despite the local strain being prevalent, the vaccine was 100 percent effective.

The Tel Aviv research appears to corroborate a recent study from Ben-Gurion University of the Negev, which found that the vaccine response is less effective against the South African variant. It drew its conclusion by analyzing blood samples, while the new research is based on actual sequenced test results.

Stern emphasized that the South African variant remains uncommon within the vaccinated population, and stressed that the study does not precisely indicate the level of protection against the variant, because its prevalence in Israel is very low – about 1% of all cases.

The study also examined the so-called British variant’s ability to break through the vaccine’s defenses, compared to the original strain. No difference was found in the UK variant’s ability to infect fully vaccinated individuals (after two doses). However, it was more able to infect partially vaccinated individuals than the original.

In Israel, the massive spread of the extra-contagious British variant starting in early January — to the point that it now accounts for more than 90% of COVID cases — is believed to have been responsible for a major wave in the first months of the year, slowing the exit from the pandemic.

But Stern said it may well have had a silver lining: In the battle between variants, the British is far stronger, and may well be keeping the South African at bay.

“It is possible that the extensive spread of the British variant is blocking the spread of the South African variant,” she said. “Because it spread so effectively, it basically didn’t allow the South African variant to spread — it won the competition.”

With more than half the population fully vaccinated, the pandemic is now on the decline, with new daily infections in the low hundreds.
 

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Pfizer CEO says third Covid vaccine dose likely needed within 12 months​

PUBLISHED THU, APR 15 20211:23 PM EDTUPDATED THU, APR 15 20213:07 PM EDT
Pfizer CEO Albert Bourla said people will “likely” need a third dose of a Covid-19 vaccine within 12 months of getting fully vaccinated. His comments were made public Thursday but were taped April 1.

Bourla said it’s possible people will need to get vaccinated against the coronavirus annually.




“We need to see what would be the sequence, and for how often we need to do that, that remains to be seen,” he told CNBC’s Bertha Coombs during an event with CVS Health. “A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role.”

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said.

The comment comes after Johnson & Johnson CEO Alex Gorsky told CNBC in February that people may need to get vaccinated against Covid-19 annually, just like seasonal flu shots.

Researchers still don’t know how long protection against the virus lasts once someone has been fully vaccinated.

Pfizer said earlier this month that its Covid-19 vaccine was more than 91% effective at protecting against the coronavirus and more than 95% effective against severe disease up to six months after the second dose. Moderna’s vaccine, which uses technology similar to Pfizer’s, was also shown to be highly effective at six months.


Pfizer’s data was based on more than 12,000 vaccinated participants. However, researchers say more data is still needed to determine whether protection lasts after six months

Earlier Thursday, the Biden administration’s Covid response chief science officer, David Kessler, said Americans should expect to receive booster shots to protect against coronavirus variants.

Kessler told U.S. lawmakers that currently authorized vaccines are highly protective but noted new variants could “challenge” the effectiveness of the shots.

“We don’t know everything at this moment,” he told the House Select Subcommittee on the Coronavirus Crisis.

“We are studying the durability of the antibody response,” he said. “It seems strong but there is some waning of that and no doubt the variants challenge ... they make these vaccines work harder. So I think for planning purposes, planning purposes only, I think we should expect that we may have to boost.”

In February, Pfizer and BioNTech said they were testing a third dose of their Covid-19 vaccine to better understand the immune response against new variants of the virus.

Late last month, the National Institutes of Health started testing a new Covid vaccine from Moderna in addition to the one it already has, designed to protect against a problematic variant first found in South Africa.

Moderna CEO Stephane Bancel told CNBC on Wednesday that the company hopes to have a booster shot for its two-dose vaccine available in the fall.
 

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Some talking points from the NY Times

 

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Until this moment, there is no solution other than prevention and being careful to use alcohol and a medical mask on an ongoing basis, and in the event that any symptoms appear, medical drugs for influenza should be used because of their great effectiveness on the virus, especially in the first days.
 

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In the city I live in they announced that there is no wait for vaccine appointments, and like what was pointed out in the article in post #27, people that can afford to are coming to Texas from all over the world


As pandemic surges anew, global envy and anger over U.S. vaccine abundance​

As India announced a grim records - the highest daily coronavirus infection tallies in a single country - Americans were enjoying a spring of vaccine abundance.

In India, just 1.4% of the population has been fully vaccinated, and overwhelmed hospitals have been running short of oxygen. Meanwhile, in the United States - where 1 in 4 Americans are fully vaccinated and more than 40% have gotten at least the first dose - a major Miami hospital, Jackson Memorial, said it would begin winding down vaccinations because of excess supply and weakening demand.

In Michigan, health workers are rolling out shots to high school students. In North Carolina, doses sat on shelves earlier this month during a pause for spring break.

"We have all the kindling to start fires everywhere," she said in an interview. "We're sitting on a powder keg."

It is happening at a demarcation point in the pandemic. In some countries with high vaccination rates - including the United States, Britain and Israel - coronavirus numbers are decreasing or plateauing. But globally, the number of new cases per week has nearly doubled since February, according to the WHO, particularly as some nations in the developing world witness their highest infection rates yet.

"Many countries still have no vaccines whatsoever," said Rob Yates, executive director of the Center for Universal Health at Chatham House, a London-based think tank. "You're seeing much anger, and I think it's justified."

The surging numbers come as a chain reaction of vaccine nationalism is hindering the flow of doses to poorer nations through Covax, a WHO-backed effort to distribute vaccines around the world.

India, a massive vaccine maker - mostly producing the AstraZeneca formula - has largely stopped exporting as its own surge worsens, dealing a major setback to the slow Covax rollout. The global initiative had expected 71% of its initial doses to come from India's Serum Institute, the country's largest vaccine maker. But so far, Covax has delivered 43 million doses of its 2 billion-dose goal this year.

On Friday, India set global single-day record of more than 314,000 new cases on Thursday.

Critics in India, in turn, have blamed the United States for policies that have curbed the export of vaccines - as well as the supplies used to make them. The Trump administration tapped the Defense Production Act to hasten vaccine development. The Biden administration has also used it, including to increase production of materials used in vaccine manufacturing.

The White House stresses that the rules do not amount to an export ban. Critics, however, say the result is similar because it allows U.S. companies to cut to the front of the line for supplies, effectively shoving some global customers toward the back.

"Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up," Adar Poonawalla, head of India's Serum Institute, tweeted to Biden on April 16. "Your administration has the details."

"It is disastrous for low- and middle-income countries," said Lawrence Gostin, a professor of global health law at Georgetown University, "particularly countries like India who could be the engine to vaccinate the world."

Many developing nations argue that the United States and other wealthy Western countries could rapidly boost global vaccine supplies by temporarily suspending pharmaceutical companies' intellectual property rights. That could allow poorer countries to produce their own versions of trademarked vaccines, such as Pfizer's or Moderna's.

In March, the United States, Britain and members of the European Union blocked a World Trade Organization proposal backed by roughly 80 nations, including India and South Africa, to waive patent protections for coronavirus vaccines. The WTO plans to revisit the issue in May. A group of U.S. senators led by Bernie Sanders, I-Vt., Elizabeth Warren, D-Mass., and Tammy Baldwin, D-Wis., along with former heads of state and Nobel laureates, have urged Biden to support a temporary waiver.

Nicholas Lusiani, senior adviser at the anti-poverty group Oxfam America, said Biden administration officials indicated a potential about-face to support the proposal during recent talks with the group. He said Washington was also considering backing an ambitious effort to help fund vaccine manufacturing hubs in Latin America and Africa.

"In the last few weeks, we've seen a groundswell of support for what was seen as a place the U.S. would never go - temporarily suspending patent rights," Lusiani said.

A Biden administration official, who spoke on the condition of anonymity because they were not authorized to speak to media, declined to specify whether it would support the trademark waiver. In remarks to a virtual WTO summit last week, however, U.S. Trade Representative Katherine Tai suggested the status quo was not working.

"This is not just a challenge for governments," she said. "This challenge applies equally to the industry responsible for developing and manufacturing the vaccines."

The administration has defended its response, pointing to its financial support for Covax - it has pledged funding up to $4 billion - as well as plans to work with Australia, Japan and India to boost supply in Southeast Asia in the years ahead.

Separately, the Biden administration has "loaned" a combined 4 million doses of AstraZeneca's vaccine - not yet authorized by U.S. regulators - to Mexico and Canada. France this week donated about 100,000 doses to Covax and has said it may contribute 13 million doses by the end of the year. New Zealand has pledged 1.6 million doses to Covax.

Both China and Russia have focused on bilateral vaccine diplomacy, but have also said they will work with Covax in some way.

Biden suggested Wednesday that vaccine donations to Covax may be in the offing at some point. But he has stopped short of outlining a timeline or strategy for sharing the U.S. surplus, which could reach 300 million doses or more by the summer, according to an estimate from researchers at Duke University's Global Health Innovation Center.

The vaccine divide is not just between rich and poor, but between wealthy neighbors, too. Canada brokered advance-purchase agreements with several pharmaceutical firms for hundreds of millions of potential doses, far more than it needs for its 38 million people. But it has had limited capacity to manufacture coronavirus vaccines at home, leaving it eying the U.S. rollout with jealousy and some resentment.

"You really see who your friends and foes are," Ontario Premier Doug Ford told reporters last month, suggesting "our closest friend" Washington should be doing more to help. "I thought I'd see a little bit of a change with the new administration, but, again, it's every person for themselves out there."

What the World Bank classifies as 'high-income countries" - accounting for just 16% of the world's population - have locked up more than 50% of near-term supply, according to research from Duke University.

There is no question the United States is practically rolling in vaccines.

All Americans 16 and over are now eligible for a shot. Health officials in states including West Virginia, North Carolina and Pennsylvania have said that supply is already exceeding demand, and their new challenge is combating vaccine hesitancy.

While it's difficult to determine exactly how many vials of vaccines are sitting unused across the United States, data from the Centers for Disease Control and Prevention indicates that a dozen states are administering less than three-quarters of the doses they receive.

A spokesperson for the vaccine alliance Gavi, a partner in Covax, said vaccine deliveries were happening faster now than during the H1N1 "swine flu" pandemic in 2009, when a few wealthy countries tied up almost all the global supply. Covax is also seeking to make up for delays in exports from India by pursuing deals with other vaccine makers.

But countries are growing impatient.

In Namibia, home to 2.5 million people, only 128 people had received two doses of vaccines as of mid-April.

"We did apply and paid our deposit for the covid vaccine, but there is a vaccine apartheid," Namibia's president, Hage Geingob, told reporters this month. "I'm saying that we, a small country, have paid a deposit but up to now we didn't get any vaccine."

Guatemala's president, Alejandro Giammattei, echoed those sentiments, saying Covax had failed his country and Latin America at large. He said Guatemala - where cases are spiking - has had to turn to India and Russia for vaccines, because it has only received 81,000 of the 3 million doses of the AstraZeneca vaccine it purchased through Covax.

"The Covax system has been a failure," he said. "A small group of countries have all the vaccines and a large number do not have any access."

Countries in the Caribbean - which consider themselves a "third border" with the United States - have expressed particular frustration with Washington. Timothy Harris, prime minister of St. Kitts and Nevis, said in an interview with The Washington Post that India had stepped in to aid his and other Caribbean nations with thousands of doses.

"But from the United States, disappointedly, we have not had one dose of vaccines," he said. "Not one dose."
 
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