The decision was made by an influential committee of outside experts who advise the Food and Drug Administration.

In a surprising turn, the panel rejected, by a vote of 16-2, boosters for almost everyone. Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.

Then, in an 18-0 vote, it endorsed the extra shot for select portions of the U.S. population — namely, those most at risk from the virus.

That would help salvage part of the White House’s campaign but would still be a huge step back from the far-reaching plan proposed by the administration a month ago to offer booster shots of both the Pfizer and Moderna vaccines to practically everybody eight months after they get their second dose.

Friday’s vote was just the first step in the process. The FDA itself is expected to make a decision on boosters in the next few days, but it usually follows the committee’s recommendations.

The offering of boosters is also subject to approval by the Centers for Disease Control and Prevention. A CDC advisory panel is expected to take up the question on Wednesday. The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

Separate FDA and CDC decisions will be needed in order for people who received the Moderna or J&J shots to get boosters.

During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to almost everybody 16 and over.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

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Dr. Amanda Cohn of the CDC said: “At this moment it is clear that the unvaccinated are driving transmission in the United States.”

Scientists inside and outside the government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough COVID-19 vaccine for their first.

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant.

The surprise turn of events could reinforce recent criticism that the Biden administration got out ahead of the science in its push for boosters. President Joe Biden promised early on that his administration would “follow the science,” following disclosures of political meddling in the Trump administration’s coronavirus response.

The FDA panel’s overwhelming initial rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July.

Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.

“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.

And representatives for Pfizer argued that it is important to shore up immunity before protection against severe disease starts to erode. A company study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but had dropped to 84% by around six months.

Both Pfizer and the Israeli representatives faced pushback from panelists. Several were skeptical about the relevance of Israel’s experience to the U.S. Another concern was whether third doses would exacerbate serious side effects.

Meissner said he was worried about extra doses for younger age groups, given the risk of heart inflammation that has been seen in mostly younger men after a second dose. While the condition is very rare, he said, it is not clear if that risk would increase with another dose.

Pfizer pointed to Israeli data from nearly 3 million COVID-19 boosters to suggest side effect rates would be similar to that seen after second doses.

Dr. Paul Offit, a COVID-19 vaccine expert at Children’s Hospital of Philadelphia, said he was supportive of the third dose for adults over 60 or 65, but “I really have trouble” supporting it for anyone down to age 16.

While an extra shot likely will at least temporarily decrease cases with mild or no symptoms, “the question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much,” Offit said.

Source – https://www.newsmax.com/

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On Sunday President Nana Akufo-Addo countered some of the common false statements and conspiracies about the safety and efficacy of the approved jabs.

The vaccine, Mr Addo said, does not change your DNA, it’s not part of a global cabal plan to “wipe out Africans,” and will not cause infertility.

The president also said experts from Ghana’s Food and Drugs Authority had declared the Oxford/AstraZeneca vaccines safe.

The country’s scientists have also approved Russia’s Sputnik V vaccine and were also involved in research to develop other jabs.

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To rollout the vaccination, the National Vaccine Deployment Plan has segmented the population into four groups in order of priority:

Frontline health workers, people with underlying health conditions, and people aged 60 and above will be among the first to be vaccinated.

Key workers in the executive, legislature judiciary, and security services including some journalists will also get the opportunity to receive the jabs.

But pregnant women and children below 18 years old are not part of the vaccination campaign.

The authorities have said they don’t have enough data on the possible side effects of the vaccines on such groups.

Source – https://www.montageafrica.com/

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But don’t expect that good news to be repeated in 2020. 

The impact of COVID-19 and other ills are projected to boost the death rate by 15% to exceed 3 million deaths for the first time in U.S. history, according to the Associated Press. 

COVID-19 has already killed more than 318,000 Americans.

According to the AP,  preliminary data suggest a year-end total for 2020 of more than 3.2 million U.S. deaths. That would be a new record and represent 400,000 more deaths than were recorded for 2019.

The news agency noted that the rise from 2019 to 2020 marks the biggest such jump since 1918-1919, when deaths soared due a combination of fatalities from World War I and the Spanish Flu pandemic. That remains the record period for any one-year uptick in American deaths, with fatalities rising by 46%, the AP reported.

This year’s big rise in death comes after a welcome rise in Americans’ life expectancy during 2019, according to new data for last year, issued on Tuesday by the U.S. Centers for Disease Control and Prevention. 

The agency reported a record number of deaths nationwide in 2019 — 2,854,838, up 15,633 from 2018, which is expected as population rises. But life expectancy actually rose by 0.1 year, so that the average American had a life expectancy in 2019 of 78.8 years. 

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Put another way, the age-adjusted death rate fell from 723.6 deaths per 100,000 population in 2018 to 715.2 in 2019.

However, “I would expect this to reverse in 2020, due to COVID, as well as the increases in deaths due to disrupted medical and social services from the pandemic,” said Dr. Eric Cioe-Peña, director of Global Health at Northwell Health in New Hyde Park, N.Y. He wasn’t involved in the new CDC reports.

For 2019, the reports from the CDC’s National Center for Health Statistics showed that heart disease remained the No. 1 killer, claiming 659,041 lives, followed by cancer (599,601 deaths), and accidents/unintentional injuries (173,040 deaths).

In some good news, suicides fell from 48,344 in 2018 to 47,511 in 2019, and the suicide rate also declined, from 14.2 per 100,000 in 2018 to 13.9 in 2019. 

Source – https://www.newsmax.com/

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The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Thursday to review Moderna’s request for emergency use authorization.

The group of outside medical advisors recommended Pfizer’s vaccine for emergency use last Thursday, and the FDA approved it the next day. The committee is expected to recommend Moderna’s vaccine. The FDA doesn’t have to follow the committee’s recommendation, but it often does.

The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.”

“FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” it said.

The announcement helped Moderna’s stock rise 1.5% just before the opening bell.

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The documents are “enormously encouraging,” said Dr Paul Offit, a voting member on the committee, adding they show there are now two highly effective vaccines. He voted in favour of recommending Pfizer’s vaccine last week.

Moderna is asking the FDA to approve the use in people age 18 and over, while Pfizer’s vaccine was cleared for use in people age 16 and older. The scant data in younger teens was a sticking point for the few members of the advisory committee who voted against authorizing Pfizer’s vaccine last week.

Source – https://www.cnbc.com/

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“If you have a sudden onset of symptoms such as not being able to catch your breath, pressure and pain in the chest, nausea to where you can’t keep water down, ongoing diarrhea and light headedness, for example, seek immediate medical care,” said Dr. Imran Naqvi, associate program director of internal medicine at the Jewish Hospital at Mercy Health in Cincinnati.

Dr. James Horn, an emergency specialist at St. Elizabeth Healthcare advises consulting with your healthcare professional first, but added that if the symptoms you are experiencing become unbearable, go to the hospital. Shortness of breath simply walking across the room would be an emergency signal, he said, according to the Enquirer.

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If your child is feeling poorly with COVID-19, it is best to call your pediatrician for advice or schedule a telehealth visit, said Dr. Mary Carol Burkhardt, of Cincinnati Children’s Hospital. “It’s important that your child can breathe comfortably and tolerate fluids,” she said.  “If you child is having significant trouble breathing or can’t catch his or her breath, you child needs to be seen by a healthcare provider right away.”

The Centers for Disease Control and Prevention offers a list of emergency warning signs for COVID-19 that include:

• Trouble breathing
• Persistent pain or pressure in the chest
• New confusion
• Inability to wake or stay awake
• Bluish lips of face

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Read Newsmax: When You Should Go to the Hospital With COVID-19 | Newsmax.com
Urgent: Your Heart Attack Risk Determined Online – More Info

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People are sharing stories of how their teeth or gums weakened, fell out, became discolored or broke.

Dentists say it’s too early to establish a well-linked connection between the coronavirus and oral health, though.

”We are now beginning to examine some of the bewildering and sometimes disabling symptoms that patients are suffering months after they’ve recovered from Covid,” Dr. William W. Li, president and medical director of the Angiogenesis Foundation, a nonprofit that studies the health and disease of blood vessels, told the Times.

Li said teeth falling out without any blood is unusual and could mean there’s an issue with blood vessels in the gums. SARS-CoV-2 directly infects endothelial cells via ACE2, a protein on the surface of many cell types. Endothelial cells form the inner lining of blood vessels. Blood vessels keep the teeth alive.   

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Read Newsmax: NYTimes: Some COVID-19 Survivors Report Issues With Oral Health, Including Teeth Falling Out | Newsmax.com
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Coronavirus can also cause the immune system to overcompensate, leading to a ”cytokine storm,” says Dr. Michael Scherer, a prosthodontist in California.

”Gum disease is very sensitive to hyper-inflammatory reactions, and Covid long haulers certainly fall into that category,” Scherer told the Times.

Nearly 13 million Americans have been infected with COVID-19 and about 263,000 have died.

Source – https://www.newsmax.com/

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“Often the big news story has a technical word that’s associated with it and in this case, the word pandemic is not just technical but has become general.

“It’s probably the word by which we’ll refer to this period in the future,” he said.

The word took on urgent specificity in March, when the coronavirus crisis was designated a pandemic.

But it started to trend up on Merriam-Webster.com as early January and again in February when the first US deaths and outbreaks on cruise ships occurred.

On March 11, when the World Health Organization declared the novel coronavirus outbreak a global pandemic, lookups on the site for pandemic spiked hugely.

Site interest for the word has remained significantly high through the year, Sokolowski said.

By huge, Sokolowski means searches for pandemic on March 11 were 115,806% higher than lookups experienced on the same date last year.

Pandemic, with roots in Latin and Greek, is a combination of “pan,” for all, and “demos,” for people or population.

The latter is the same root of “democracy,” Sokolowski noted.

The word pandemic dates to the mid-1600s, used broadly for “universal” and more specifically to disease in a medical text in the 1660s, he said.

That was after the plagues of the Middle Ages, Sokolowski said.

He attributes the lookup traffic for pandemic not entirely to searchers who didn’t know what it meant but also to those on the hunt for more detail, or for inspiration or comfort.

“We see that the word love is looked up around Valentine’s Day and the word cornucopia is looked up at Thanksgiving,” Sokolowski said.

“We see a word like surreal spiking when a moment of national tragedy or shock occurs. It’s the idea of dictionaries being the beginning of putting your thoughts in order.”

Merriam-Webster acted quickly in March to add and update entries on its site for words related to the pandemic.

While “coronavirus” had been in the dictionary for decades, “COVID-19” was coined in February.

Thirty-four days later, Merriam-Webster had it up online, along with a couple dozen other entries that were revised to reflect the health emergency

Source – https://www.pmnewsnigeria.com/

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Forces will have access to information telling them if an individual has been told to self-isolate, the Department of Health and Social Care (DHSC) said.

But the British Medical Association said it was worried police involvement might put people off being tested.

In England there is a legal requirement to isolate after a Coronavirus positive test.

Just under 11% of people traced as a close contact of someone with coronavirus said they self-isolated for 14 days, according to a government-commissioned study.

Reasons given for breaking self-isolation included believing there was no point isolating from strangers if you cannot properly distance from those in your household; not developing symptoms; or visiting shops or a pharmacy.

‘Appropriate safeguards’

The DHSC updated its guidance about how testing data will be handled on Friday.

A memorandum of understanding was issued between the DHSC and National Police Chiefs’ Council to allow forces to access information that tells them if a “specific individual” has been told to self-isolate, as first reported by the Health Service Journal.

Those who fail to do so face fines starting at £1,000, which can increase to £10,000 for serial offenders or serious breaches.

A DHSC spokesman said it was a legal requirement for people who had tested positive and their close contacts to self-isolate when formally notified to do so.

“The memorandum of understanding ensures that information is shared with appropriate safeguards and in accordance with the law. No testing or health data is shared in this process,” he said.

A spokesman for the British Medical Association, which represents doctors in the UK, said the test-and-trace system needed “the full confidence of the public” to be effective.

He said: “We are already concerned that some people are deterred from being tested because they are anxious about loss of income should they need to self-isolate – and we are worried should police involvement add to this.

“Therefore, the government’s emphasis should be on providing support to people – financial and otherwise – if they need to self-isolate, so that no-one is deterred from coming forward for a test.”

A National Police Chiefs’ Council spokesperson said forces would continue to encourage “voluntary compliance” but would enforce regulations and issue fines where appropriate.

“Officers will engage with individuals to establish their circumstances, using their discretion wherever it is reasonable to do so,” they said.

Sir Ed Davey, leader of the Liberal Democrats, said ministers should “reverse the policy urgently”.

“Anything that further undermines the public’s dwindling trust in this government’s handling of the pandemic is damaging, and few things could have been better designed to do that, than this,” he said.

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Meanwhile, Baroness Dido Harding, the head of NHS Test and Trace, has told the Sunday Times that the Test and Trace service was not a “silver bullet”.

“It has never been and it never will be,” she said, adding it is one of a number of different interventions needed to control Covid-19.

Source – https://www.bbc.co.uk/

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It’s a dramatic turnaround – Mr Trump previously mocked others for wearing masks, and suggested some might wear such personal protective equipment to show their disapproval of him, even after the US Centers for Disease Control recommended face coverings.

Meanwhile, the UK government was initially reluctant to advise the general public to wear face coverings, even as other countries in Europe did.

It introduced rules requiring people to wear face coverings on public transport in June and now says people in England must wear face coverings in shops or face a fine.

Globally, many authorities – including the World Health Organization (WHO) – initially suggested that masks were not effective in preventing the spread of the coronavirus. However, they are now recommending face coverings in indoor spaces, and many governments have even made them mandatory.

What’s changed – and why?

The number of governments recommending face coverings has gone up significantly over the past six months.

As of mid-March, about 10 countries had policies recommending face coverings – now more than 130 countries and 20 US states do, says Masks4All, an activist group of researchers that advocates the use of homemade masks during the pandemic.

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Some studies also suggest that people’s attitudes have changed.

“Countries with no previous history of wearing face masks and coverings amongst the general public rapidly adopted usage such as in Italy (83.4%), the United States (65.8%) and Spain (63.8%),” says a report by the Royal Society – one of the leading science bodies in the UK.

The changes appear to be partly due to a better understanding of how Covid-19 spreads.

Initially, the WHO said masks should only be worn by medical workers, or people who had symptoms like coughing and sneezing.

However, in recent months, there’s been increased evidence that many people with the virus do not have symptoms – but can still be contagious – and masks can stop them from passing it on to others. The WHO changed its guidance in June.

Meanwhile, there is more awareness that the risk of transmission is higher in poorly ventilated indoor spaces – and evidence to suggest that the virus could be spread by tiny particles suspended in the air.

This means that if everyone wears face coverings it will “protect against the most common mode of transmission – droplets – and to some extent maybe aerosol droplets,” says Kim Lavoie, chair of behavioural medicine at the University of Quebec at Montreal’s psychology department.

Source – https://www.bbc.co.uk/

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The White House has been increasingly critical of Dr Fauci, and on Sunday, an official shared a list detailing past apparent erroneous comments.

Dr Fauci changing advice on masks and remarks on Covid-19’s severity are among the points from the White House.

The move to undercut him comes as the US continues to see surges in Covid-19.

There are over 3.3 million cases confirmed and more than 135,000 deaths nationwide, according to Johns Hopkins University.

Dr Fauci has contradicted President Donald Trump’s comments on the pandemic a number of times, pushing back on the president’s claims that the outbreak is improving and attributing hasty state reopenings to the recent surges.

The White House memo leaked over the weekend had noted “several White House officials are concerned about the number of times Dr Fauci has been wrong on things”.

Though the White House said Dr Fauci and Mr Trump have a “good working relationship” on Monday, Trump adviser Peter Navarro told CBS News: “When you ask me if I listen to Dr Fauci’s advice, my answer is only with caution.”

During a law enforcement event at the White House on Monday, Mr Trump said: “I have a very good relationship with Dr Fauci. I’ve had for a long time – right from the beginning.

“I find him to be a very nice person. I don’t always agree with him.”

The president added: “I get along with him very well. I like him personally.”

Mr Trump earlier on Monday retweeted comments from a game show host accusing “everyone”, including the US Centers for Disease Control (CDC), of lying about the coronavirus.

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White House press secretary Kayleigh McEnany later told reporters Mr Trump still had confidence in the CDC and the tweet was meant to express his displeasure with “some rogue individuals” who leaked planning documents.

Echoing the contents of the anti-Fauci memo earlier, Mr Navarro, an economic adviser to Mr Trump, said Dr Fauci “has been wrong about everything I have ever interacted with him on”.

“When I warned in late January in a memo of a possibly deadly pandemic, Fauci was telling the media not to worry,” he said.

Mr Navarro said Dr Fauci fought against Mr Trump’s “courageous decision” to halt flights from China, initially said the virus was “low-risk” and “flip-flopped on the use of masks”.

“Now Fauci is saying that a falling mortality rate doesn’t matter when it is the single most important statistic to help guide the pace of our economic reopening.”

Admiral Brett Giroir, assistant US health secretary and member of the virus task force, told NBC News on Sunday that while he respects Dr Fauci, he is not always right.

“Dr Fauci is not 100% right and he also doesn’t necessarily, he admits that, have the whole national interest in mind. He looks at it from a very narrow public health point of view.”

As cases and deaths continue to rise in a number of states, Mr Trump has been accused by critics of politicising health issues, including wearing masks.

Mr Trump has also clashed with the World Health Organization (WHO), accusing the body of mismanaging the pandemic when it began and failing to make “greatly needed reforms”.

On 7 July, he formally began to pull the US out of the WHO and said funding would be redirected.

Source – https://www.bbc.co.uk/news/

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