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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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