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Pfizer and Moderna safe and effective for under 5

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Food and Drug Administration staff said Sunday the coronavirus vaccine made by Pfizer and its German partner, BioNTech, for children younger than 5 is effective in producing a virus-blocking response and did not raise safety concerns, a prelude to a crucial review this week by the agency’s independent advisers.

The three-dose Pfizer-BioNTech vaccine for kids ages 6 months through 4 years will likely benefit this age group, the FDA said, noting higher hospitalization and death rates among the youngest children in the U.S. compared with those 5 and older.

The analysis by FDA scientists was released ahead of a meeting Wednesday of the agency’s independent experts, who will consider a request for emergency use authorization for the Pfizer-BioNTech vaccine in the youngest children. It will also review a request from Moderna to use its vaccine in children younger than 6. FDA staff Friday said Moderna’s shot for infants and young children was safe and effective.

After the advisers make their recommendations, the FDA will decide whether to follow the panel’s advice, which it often does. If the agency clears the vaccines, and the Centers for Disease Control and Prevention signs off, the shots could be available beginning next week.

The FDA said the Pfizer-BioNTech vaccine met the main requirement for effectiveness — it generated an immune response at least as strong as the protection afforded to young adults from the vaccine.

Overall, the agency said, preliminary data indicated the vaccine was 80.4 percent effective in preventing symptomatic covid-19. The rate was 75.6 percent for babies and toddlers six to 23 months old, and 82.4 percent for children 2-to-4-years-old.

But the FDA said it was too soon to reach “definitive conclusions” on the vaccine’s effectiveness.

Side effects were minimal and included irritability and drowsiness for children 6-to-23-months-old, and pain at the injection site and fatigue for children 2 to 4, the FDA said.

Babies and children younger than 5 — a group numbering 19 million — remain the only age group in the United States not yet eligible for a coronavirus vaccine.

Some parents have been eagerly awaiting vaccines for their young children, anxious to provide them the same protection that older children, teenagers and adults have had for some time. But surveys show most parents intend to wait before getting their children vaccinated, or are not interested in the pediatric vaccines.

The FDA made clear Sunday it believes vaccines for the youngest group are critical. Given the uncertainty of the pandemic and likely continued virus transmission in coming months, “deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group,” the agency said.

Vaccines for young children have followed a twisting — and often confusing — path, marked by disappointing results, delays and changes in regulatory strategies.

Pfizer and BioNTech initially tested a two-shot vaccine regimen but announced last December that the approach failed to meet the immune-response goal for the 2-to-4-year-old group. The vaccine makers added a third shot to their trial, delaying vaccine availability by months.

But in late January, federal officials made the surprising suggestion that there might be a path forward for the two-dose regimen, despite the disappointing results. They said that even if the vaccine missed the immune response target, which is measured in the laboratory, the vaccine still might protect children from infections.

But that data turned out to be disappointing, too, with only 28.3 percent effectiveness, according to the most recent figures, reflecting the emergence of the omicron variant of the coronavirus. The FDA dropped the plan to accelerate the vaccine and decided to await results from a third dose.

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Surviving Covid at age 105

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A NSW aged care resident who recently battled Covid, has just celebrated her 105th birthday.

May Harrison, who is thought to be Australia’s oldest Covid survivor, hit the milestone birthday, surrounded by family and friends.

“I was very sick and when I came out of it, I was very weak, but I got over it,” she told the ABC. “We were to have had a bigger [party] on the Sydney Harbour but they didn’t think I was strong enough.

“But I love my parties.”

Ms Harrison is one of nearly 46,000 aged care residents in Australia who have so far had Covid. That is despite regulations put in place to protect this vulnerable cohort.

And as the country returns to ‘normal’ as we “learn to live with Covid”, the numbers of those instead dying with Covid have been steadily rising this year.

May is one of the nearly 46,000 Australian aged care residents who have contracted COVID-19 since the start of the pandemic.

And although the daily press conferences are long gone — and, for many people, life has returned to something much closer to normal — COVID-19 cases in Australia remain at around 45,000 per day.

Experts are warning that COVID-19 still “has tricks up its sleeve” with reinfections rising and new strains emerging.    

 

Aged care under COVID strain 

Last week, there were more 780 active outbreaks in aged care facilities and the sector is under pressure.

Whiddon Aged Care runs 20 centres across NSW and Queensland, including the facility where May lives in south-west Sydney.

Its chief executive, Chris Mamarelis, said the company had strict health and safety practices on site, but the high community transmission across the country meant the impact of COVID-19 was still a threat.

“All of our homes are being impacted by COVID,” he said.

But high vaccinations and strong infection management have helped keep things relatively under control, he added.

Mr Mamarelis said the high case numbers were taking a devastating toll on the aged care workforce — and he was worried about reinfection. 

“We’re seeing a lot of staff that are having to isolate who are contracting COVID,” he said.

“We’re not finding the backup — they’re just not there. So there’s immense pressure [particularly] in those regional locations where team members are working 12-hour shifts.”

Outside of aged care, large numbers of people continue to contract the virus in the wider community.

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5 steps in writing an effective e-mail

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  1. Keep your e-mails short

Less is more. The shorter you can keep your e-mail while still relaying your message or question the better. At most we suggest no more than three paragraphs of text.

 

  1. Make the subject line clear and easy to read

The subject of the e-mail should contain enough information to let the recipient know the contents of an e-mail.

 

  1. Make the e-mail personal

Always include the name or alias of the e-mail recipient. If you want the e-mail to be even more personal include your real name in the e-mail as well.

 

  1. Watch your spelling and grammar

E-mail with spelling and other grammatical errors tells the reader it’s not that important. Always spell check, keep the below suggestions in mind, and proofread the e-mail before sending it out.

– Always use proper punctuation and capitalization.

– Never use shorthand or acronyms people don’t understand.

– Do not WRITE IN ALL CAPS; it gives the impression you’re YELLING.

 

  1. Use a clean signature

Signatures is an effective method of displaying your contact information at the bottom of e-mails. However, follow e-mail signature etiquette when creating a signature.

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Is Australia a Covid success?

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The pandemic – and PM Scott Morrison’s handling of it – was once expected to be a central element of his campaign to be re-elected. But with the election just a week away, Covid seems to have taken a backseat in Australian politics.

Mr Morrison took credit for saving thousands of lives in his first campaign video – a reminder of 2020 when infections first gripped Europe and the US, but life in much of Australia largely went on as usual.

Australia was hailed as a Covid success story as days went by with zero cases. But as the pandemic h1as worn on, that theory has been put to test.

The initial success

When the first cases emerged in Australia, Mr Morrison’s government reacted quickly with strict measures that controlled its spread. Every state too adopted fast and firm lockdowns, test and trace protocols, social distancing and mask mandates to contain outbreaks.

The country shut its borders – Australians couldn’t leave without official permission and those allowed in had to go through a two-week hotel quarantine. When the vaccines arrived, the drive picked up after a slow start. Australia is now one of the most vaccinated countries in the world with 95% of its eligible population double-jabbed.

It has also recorded just over 7,000 Covid deaths to date – a small number compared to other developed nations. Last week, the World Health Organization found Australia had recorded fewer deaths in 2020 and 2021 – from Covid or otherwise – than it had in a normal year.

But Australia’s harsh border policies and lockdowns came at a huge cost. Tens of thousands of people were locked in or out of the country, separated from their families.

The restrictions, however, couldn’t stop the highly transmissible and vicious Delta variant from breaking through in the middle of 2021. Mr Morrison, who had frequently boasted of Australia’s success in controlling the virus’ spread, asked people to “hang in there”. And when he was criticised for the slow vaccine rollout, he made a now-infamous comment that it “isn’t a race”.

From control to crisis

But the Omicron variant brought fresh panic and the government was caught off-guard again.

Australia’s case count, which stood at nearly 400,000 cases by the end of 2021, jumped to 2.1 million over the next month. While deaths have remained relatively low, Australia has already had more than twice as many Covid deaths this year compared to 2020 and 2021 combined.

Australians had swung from one extreme to another. After months of restrictions, they were left to navigate the new reality of living with the virus on their own – and this was while cases soared.

People queued for hours at overwhelmed PCR testing clinics, only to be turned away in the end. Rapid antigen tests were expensive and not available for a time. Rules about what constituted a “close contact” were confusing and officials flip-flopped on mask and other safety mandates.

As staffing and supply chains suffered, supermarkets emptied out and businesses struggled to survive.

But one of the starkest failures happened in the aged care sector. It was already struggling, but Covid proved devastating. Three quarters of the 910 Covid deaths in 2020 were aged care residents, according to a review by Lyn Gilbert, honorary professor at the Faculty of Health and Medical Science in the University of Sydney.

 

Will Covid matter in this election?

Mr Morrison has at times used the campaign to talk up his economic handling of Covid. And his opponent, Anthony Albanese, used one question in a leader’s debate to get the prime minister to concede that his comment – “it’s not a race” – was miscalculated.

And yet, Covid has barely been mentioned otherwise. Professor “It’s somewhat surprising given that Australian news coverage for the last few years was dominated by Covid stories and different appraisals of state and federal government’s handling of the various aspects of Covid,” said Andrea Carson, associate professor of journalism and political science at La Trobe University.

Professor Carson added that data from a sample survey of 100,000 people by the national broadcaster ABC showed that Covid was a long way down the list of issues on voter’s minds.

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