Tag Archives: Launch of the COVID-19 vaccine

Amidst AstraZeneca’s decline, Germany is relying on home vaccines | Instant News


BioNTech, the German company developing the first widely used vaccine together with US partner Pfizer, is busy starting up a production facility that it says could produce up to one billion doses this year alone. The estimate was raised from the original expectation of 700 million.

The company, which has never brought a pharmaceutical product to market before, wowed the world last year when it got the authorization to sell a completely new line of vaccines in the UK, United States and Europe – three highly regulated markets for medical products.

The active ingredient in the injection is messenger RNA, or mRNA, which contains instructions for human cells to build harmless portions of the coronavirus called spike proteins. The human immune system recognizes the spike protein as foreign, enabling it to increase its response to the virus after infection.

Scientists have known how to make mRNA for some time, but not for commercial mass production.

“This is what makes it attractive from a scientific perspective, but also from a manufacturing perspective, to do it on a large scale, in a short amount of time,” said Valeska Skilling, head of production at the plant.

BioNTech only received approval Friday from the European Medicines Agency for the manufacture of the vaccine on the Marburg site, which was purchased from Novartis last year. The site is located within a pharmaceutical industry cluster with roots dating back more than a century to Nobel Prize winner Emil von Behring, who developed an antitoxin for diphtheria and tetanus.

Globally, BioNTech and Pfizer now estimate they could produce 2.5 billion doses by 2021, half a billion more than expected in February.

To make this happen, some 400 employees face large-scale production challenges involving some 50,000 separate steps, some of which require months of training. A crucial concern in dealing with mRNA, which is notoriously fragile, is to strictly avoid external contamination. Workers, who usually have degrees in disciplines such as biology or pharmacy, must wear two protective suits, boots and a full head covering which takes 20 minutes to put on.

Last week the company showed reporters some of its production equipment, including a bioreactor, a metal drum in which mRNA is produced from raw materials fed by tubes and closely monitored. One batch can contain enough mRNA for 8 million doses in a bag no bigger than a large sack of rice. Then it is filtered and coupled with lipids, or fat molecules, which form tiny particles that envelop the mRNA and protect it after injection into the human body. The final step is to fill the bottles, carried out by an external partner.

Stung by criticism, and aware of Germany’s upcoming national elections, Berlin has supported the Marburg factory, helping to push the necessary documents through the German bureaucracy.

Christoph Krupp, king of government vaccine production, said companies are increasing their capacity, buying new equipment and hiring more staff. Meanwhile, the government is trying to convince them that the investment will not be in vain.

“We want to prepare ourselves to maintain the production structure we are building now in the medium term, because we don’t know how the pandemic is developing,” said Krupp. “We don’t know how the virus mutates … we don’t know if there will be another pandemic.”

In an interview with the daily Frankfurter Allgemeine Zeitung, Krupp said this would require state assistance, and the government was considering a vaccine production reserve of 500 million doses per quarter, or about 2 billion a year.

The government may hope that its investment will pay off. According to economists cited by Germany’s IFO-Institute, providing a vaccine in such a short period of time could yield each German a net profit of up to $ 1,750 a year.

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Jordans reported from Berlin.

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Follow all AP pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

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Latest: German hair salon reopens due to relaxed virus rules | Instant News


Hairdressers across Germany are re-opening their businesses after a 2 ½ month shutdown, another precaution as the country balances a desire to ease restrictions with concerns about the impact of a more contagious variant of the coronavirus.

BERLIN – Hairdressers across Germany are re-opening their businesses after a 2 ½ month shutdown, another cautionary move as the country balances a desire to ease restrictions with concerns about the impact of a more contagious variant of the coronavirus.

Monday’s move came after many elementary school students returned to school a week ago. This follows a February 10 decision by Chancellor Angela Merkel and 16 German state governors. They will meet on Wednesday to decide how to proceed with restrictions on Germany’s other coronavirus, which currently run until March 7.

Some states also allow businesses such as flower shops and hardware stores to open. Most shops have been closed nationwide since December 16. The restaurant, bar, sports and recreational facilities have been closed since November 2 and the hotel is only allowed to accommodate business travelers.

Germany is expected to remain cautious as the decline in infection rates has stalled, and even reversed in some areas, as the more infectious variant first spotted in Britain spreads.

On Monday, Germany’s disease control center reported 4,732 new coronavirus cases over the past 24 hours, compared with 4,369 cases a week earlier. Another 60 deaths were reported, bringing the total to 70,105.

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THE VIRUS OUTBREAK:

– Calls are growing for pharmaceutical companies to share vaccines knowledge and technology more broadly to meet global deficiencies

India is expanding the push for vaccination to the elderly and people with medical conditions that put them at risk

– Optimism abounds as the Premier League Baseball starting a spring ritual that includes fans

– Follow AP pandemic coverage on https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

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HERE WHAT ELSE HAPPENED:

MANILA, Philippines – The Philippines launched a vaccination campaign on Monday to contain one of Southeast Asia’s worst coronavirus outbreaks but is facing supply problems and public resistance, which high-ranking officials hope to resolve.

Cabinet officials, along with health officials and military and police personnel, were among the first to be vaccinated at six hospitals after 600,000 doses donated by China were received Sunday.

The Philippines has reported more than 576,000 infections, including 12,318 deaths, the second highest number in Southeast Asia after Indonesia.

In addition to the Chinese-donated vaccine from Sinovac Biotech Ltd., the government has ordered 25 million doses separately from the China-based company but no date has yet been set for delivery. Health Minister Francisco Duque III said the delivery of 525,600 initial doses of the AstraZeneca vaccine originally scheduled for Monday would be delayed for a week due to supply problems.

The government has negotiated to get at least 148 million doses from Western and Asian companies to vaccinate some 70 million Filipinos for free in a massive campaign funded by foreign and domestic loans.

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WASHINGTON – Nearly 4 million doses of the newest COVID-19 vaccine were sent to US states for injection starting Tuesday.

The White House said all supplies of the newly approved single-dose Johnson & Johnson vaccine would soon run out. J&J will provide about 16 million more doses by the end of March and a total of 100 million by the end of June, but the distribution will be delayed.

Although the new injection was easier to administer and required only one dose, the administration did not change its distribution plans.

The White House encourages Americans to take the first dose available to them, regardless of the manufacturer.

Centers for Disease Control and Prevention advisers voted heavily on Sunday to recommend vaccines for adults 18 years and over. This adds to the vaccines from Pfizer and Moderna that were passed in December.

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Brazil’s death toll stands at 250,000, the virus is still rampant | Instant News


RIO DE JANEIRO – Brazil’s COVID-19 death toll, which surpassed 250,000 on Thursday, is the second highest in the world for the same reason, the second wave has not faded: Prevention has never been a priority, experts say.

Since the start of the pandemic, Brazilian President Jair Bolsonaro has scoffed at the “little flu” and criticized local leaders for imposing restrictions on activity; He said the economy had to keep going to prevent worse hardships.

Even when he approved pandemic welfare payments for the poor, it wasn’t announced as a way to keep people at home. And Brazilians stay out and about vaccinations have started – but launches are proving to be much slower than anticipated.

“Brazil has absolutely no response plan. We have been through this for the past year and we still don’t have a clear plan, a national plan, ”Miguel Lago, executive director of the Brazilian Institute of Health Policy Studies, advising public health officials, told the Associated Press. “There are no plans at all. And the same is true for vaccinations. “

While other countries’ daily cases and deaths have declined, Latin America’s largest country is parked on the plateau – a grim repeat in mid-2020. In the past five weeks, Brazil has averaged more than 1,000 deaths every day. Official data showed the total death toll was 251,498 as of Thursday.

At least 12 Brazilian states are in the midst of a second wave that is even worse than the one faced in 2020, said Domingos Alves, an epidemiologist who has been tracking COVID-19 data.

“This scenario is going to get worse,” Alves told AP, adding that the virus is spreading more rapidly among populations. In Amazonas state, where the capital, Manaus, saw hospitals run out of oxygen last month, there have been more than 5,000 deaths in the first two months of this year, nearly as many as in 2020.

“This is the most difficult time we have experienced since the confirmation of the first case,” Carlos Lula, chairman of the National Council of Health Secretaries, was quoted as saying by the newspaper O Globo, Thursday. “We’ve never had so many states.” with so many difficulties at the same time. “

Alves and other public health experts said the spread was exacerbated by authorities’ reluctance to follow recommendations from international health organizations to impose stricter restrictions.

It’s up to governors and mayors to impose lockdowns or other restrictions to contain the virus. The states of Sao Paulo and Bahia have recently imposed curfews, but experts say the move is too late and insufficient.

“Those are not containment measures; it is palliative action, always taken after the fact, ”said Alves, who is also a professor of social medicine at the University of Sao Paulo. “‘Lockdown’ has become a curse word in Brazil.”

Miguel Nicolelis, a leading Brazilian neurologist, warned in January that Brazil had to go into lockdown or “we will not be able to bury the dead in 2021.” He has been advising the northeastern states on how to fight COVID-19, but has recently left his position, dissatisfied with their refusal to be isolated, reports the newspaper Folha de S. Paulo.

There were a few exceptions, but they remained marginal and failed to inspire a wider movement.

Sao Luis, the capital of the northeastern state of Maranhao, was the first Brazilian city to go into total lockdown last May. It worked, despite Bolsonaro’s attempts to break the restrictions and sow doubts about its efficacy, according to the state’s governor, Flávio Dino.

“It is very difficult to set distances and preventive measures,” said Dino, adding that the first hurdles were economic and social, especially after the federal government’s emergency pandemic assistance program ended last year.

Lago noted that Bolsonaro rarely even comments on the pandemic anymore, and has effectively shifted to other priorities, including gaining support in Congress to relax arms control laws and pass economic reforms. His administration is trying to recover some of the COVID-19 welfare payments, but for a small group of needy Brazilians.

The only preventive measure Bolsonaro has consistently supported is the use of treatments such as hydroxychloroquine, which have shown no benefit in rigorous studies.

The Bolsonaro administration has also adopted a hands-off approach to the vaccination campaign. That depends in large part on a deal to buy one vaccine, AstraZeneca, which is arriving late. National immunization efforts to date have relied mostly on Chinese-made CoronaVac injections secured by the state of Sao Paulo, even though the federal government is now trying to buy another.

Brazil’s decades of experience with successful vaccination programs and its large national public health care network lead many experts to believe immunization – even if it starts with a delay – will be a relatively fast-paced affair. In the previous campaign, the country of 210 million people was able to vaccinate as many as 10 million people in one day, health experts said.

Five weeks after the first injection, Brazil vaccinated only 3.6% of its population. That’s more than double that of Argentina and Mexico, but less than a quarter of Chile, according to Our World in Data, an online research site that compares official government statistics.

“There’s no way to fast with a vaccine shortage; That’s a crucial point, “said Carla Domingues, who for eight years coordinated Brazil’s national vaccination program, until leaving her position in 2019.” Until there is more supply, the pace will be slower, because you have to keep choosing who gets vaccinated. “

Meanwhile, the virus continues to run rampant across Brazil, and takes its toll.

In the city of São Paulo state, Araraquara, there have been more deaths so far this year than last year and the number of intensive care units is exceeding full capacity, with people on a waiting list to enter ICU and get treatment. Local authorities responded on Sunday by declaring a complete lockdown – making Araraquara only the second city to impose the restrictions.

“We never imagined we would reach this point,” said Fabiana Araújo, a nurse and coordinator of the city committee to fight COVID-19. “It’s the only option.”

—— AP author David Biller contributed from Rio and Mauricio Savarese from Sao Paulo.

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Italy’s Lombardy is back in a viral crisis when Brescia is on the rise | Instant News


Brescia, with a population of around 1.2 million, has seen its daily cases go from the mid-100s in early February to 901 on Wednesdays and 973 Thursdays, due to clusters of infections traced to British variants. Doctors said the number of COVID-19 patients being treated at major public hospitals rose from an average of around 200 to 300 recently.

“We can’t talk about the third wave from our point of view, just because the second wave never really ends,” said Dr. Cristiano Perani, head of the emergency room at the General Hospital of Brescia. “The increase is gradual, but has increased acceleration in recent weeks. “

Lombardy, Italy’s most populous region, has imposed a new lockdown on Brescia and is changing its vaccine strategy to direct the jabs it has on nearby provinces and cities in neighboring Bergamo. The goal of this strategy is to inoculate as many people as possible as quickly as possible in the worst affected areas.

Guido Bertolaso, who is in charge of the vaccine campaign, said the region would pass the 30% reserve the national government recommended to remain available for the second dose, and that from Thursday it would start vaccinating residents aged 60-79, much earlier than. scheduled. Lombardy recently began vaccinating people over 80, after giving health care workers and residents of nursing homes a priority.

The goal of the strategy, Bertolaso ​​said, is to create “health care” in the area with blanket vaccinations. This approach is based on studies from the UK and Israel – and even on the Lombardy data itself – which showed reduced infection rates as more people were vaccinated with just one dose.

“This is war,” Bertolaso ​​said.

Brescia’s deputy mayor, Laura Castelletti, said residents were willing to accept the new lockdown measures – which include the closure of all schools and child care centers – as long as the vaccination schedule accelerates.

“We are ready to make sacrifices if the vaccination campaign runs 24/7,” he said.

Brescia and Bergamo were the two Italian provinces hardest hit during the first wave of the pandemic, which started this time last year and quickly turned Lombardy into the epicenter of the spread in Europe.

Lombardy as a whole still accounts for nearly a third of Italy’s 96,974 confirmed COVID-19 deaths, and a fifth of the 2.87 million confirmed infections. Italy has the sixth highest confirmed death toll in the world, and the second in Europe after Britain.

The Italian vaccine campaign, which has delivered 3.92 million doses, has been slowed by delays in deliveries from three EU supplying pharmaceutical companies: Pfizer-BioNTech, Moderna and AstraZeneca.

It was not immediately clear whether the health ministry would direct any vaccine to Lombardy, given the previously established quota that had provided the most doses there.

Italy’s virus czar, Domenico Arcuri, did not respond to Fontana’s request in a statement on Thursday but boasted that the injections showed a “comforting increase” this week, averaging around 100,000 a day nationwide.

Nearly two months after Italy began its vaccination campaign on December 27, the tiny Republic of San Marino gave its first dose on Thursday. San Marino, a city-state of about 33,800 people surrounded by Italy, had to buy a dose of Russia’s Sputnik V after a delay in receiving the dose administered from Italy.

“This is the most effective weapon we have against this disease,” said Dr. Enrico Rossi, who was among the first to be inoculated. “It’s kind of a nightmare this year but we hope it will end.”

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Follow all AP pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

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Pfizer COVID-19 vaccine performs well in large ‘real world’ trials | Instant News


Pfizer’s large real-world test of the COVID-19 vaccine confirms that it is highly effective in preventing serious illness or death, even after a single dose.

Real-world tests of Pfizer’s COVID-19 vaccine on more than half a million people confirm that it is highly effective in preventing serious illness or death, even after a single dose.

The vaccine was 92% effective in preventing serious illness after two injections and 62% after one injection. The estimated effectiveness for preventing death is 72% two to three weeks after the first injection, a level that can increase as immunity increases over time.

It appears to be as effective in people over 70 as it is in younger people.

“This is very convincing … better than I thought,” said Dr. Gregory Poland from the Mayo Clinic.

Dr. Buddy Creech of Vanderbilt University agrees: “Even after one dose we can see very high effectiveness in death prevention,” he said.

Neither doctor was involved in the Israeli research but both are involved in other coronavirus vaccine work.

“I’d rather see 100 million people have one dose than to see 50 million people have two doses,” Creech said. “I see a lot of encouragement for a single dose” in the results from Israel, published by the New England Journal of Medicine.

The vaccine made by Pfizer and its German partner, BioNTech, is given in two injections, three weeks apart, in most countries.

The study was led by researchers from the Clalit Research Institute and Ben-Gurion University of the Negev in Israel, with Harvard University in the US. The study did not report on vaccine safety, only effectiveness, but no unexpected problems emerged in previous testing.

The vaccine is estimated to be 57% effective at preventing COVID-19 symptoms two to three weeks after the first dose, and 94% a week or more after the second dose.

It was 74% effective after one injection and 87% after two for preventing hospitalization, and 46% and 92% for preventing confirmed infections. Reducing infections gives hope that a vaccine can curb the spread of the virus, but this type of research can’t determine if that’s the case.

There have been 41 deaths related to COVID-19, 32 of them in people who did not get the vaccine.

Overall, the figures are comparable to the 95% effectiveness after the two doses seen in the limited testing that led US regulators to authorize the emergency use of the vaccine, Poland said. How much benefit one dose will bring has been a big question, “and there is now some data” to help inform the debate, he added.

“Perhaps the right thing to do here to protect the majority of people… is to give everyone a dose as quickly as possible. I think it’s an acceptable strategy to consider, “said Poland.

Israel has now vaccinated nearly half of its population. The newer virus variant that was first identified in the UK became the dominant strain in Israel during the study, so the results also provide some insight into how well the vaccine performs against it.

Earlier this week, two UK studies suggested a benefit even after one dose of Pfizer vaccine or a different one from AstraZeneca. Britain delayed the second shot until 12 weeks after the first shot to try to give the more people some level of protection.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is fully responsible for all content.

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