BioNTech/Pfizer expect new variant impact data 'within 2 weeks'

Germany's BioNTech said Friday it was urgently studying how well the coronavirus vaccine it developed with Pfizer protects against the new B.1.1.529 variant detected in South Africa.

"We expect more data from the laboratory tests in two weeks at the latest," a spokesperson said.

"These data will provide more information about whether B.1.1.529 could be an escape variant that may require an adjustment of our vaccine if the variant spreads globally."

The discovery of the new variant by scientists in South Africa has sparked global alarm, amid concerns its many mutations could make it even more dangerous than the highly contagious Delta strain.

A number of countries including Britain, Italy, Germany and Singapore have moved to curtail travel from South Africa and several neighboring nations to prevent the variant's spread.

BioNTech said variant B.1.1.529 "differs significantly from previously observed variants as it has additional mutations located in the spike protein".

But it said that even if its jab -- which is based on novel mRNA technology -- needed to be tweaked, changes could be made quickly.

"Pfizer and BioNTech have taken actions months ago to be able to adapt the mRNA vaccine within six weeks and ship initial batches within 100 days in the event of an escape variant," the spokesperson said.

Agence France-Presse

US authorizes COVID-19 boosters for all adults, recommends for over-50s

The United States authorized the Pfizer and Moderna COVID-19 vaccine boosters for all people aged 18 and older on Friday, as the world's hardest-hit country enters a new winter wave of the pandemic.

Boosters were previously available to the immunocompromised, people over 65, those at high risk of severe disease, and people in high risk occupations.

The new decision "helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death," acting commissioner Janet Woodcock of the Food and Drug Administration (FDA) said.

A panel of experts convened by the Centers for Disease Control and Prevention (CDC) then ratified the decision to broaden eligibility, while explicitly recommending boosters for all people over 50, even absent underlying conditions.

"I am really glad that we have clarity and streamlining of the recommendations so that all Americans can understand the vaccines that are recommended for them at this time," said Camille Kotton, an infectious disease clinician at Massachusetts General Hospital.

CDC director Rochelle Walensky formally signed off on the panel's recommendations, stating that boosters "are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays."

The FDA said it based its decision on data demonstrating a strong immune response to boosters from hundreds of people dosed with both brands of vaccines. 

Pfizer also carried out a clinical trial involving 10,000 people aged over 16 which found that the booster showed an efficacy against symptomatic infection of more than 95 percent compared to those who did not receive a booster.

Both vaccines are available to people six months after completing their primary series. 

Pfizer's vaccine is dosed at 30 micrograms, the same as the primary series, while Moderna's is 50 micrograms, half the primary series.

People who received the Johnson & Johnson one-dose vaccine were already eligible for a booster of any brand two months after their first shot.

The booster decision comes as cases are rapidly rising nationally, reaching 88,000 new infections per day on average as the country enters its fifth wave, according to the latest data. 

America is officially the pandemic's hardest-hit country, with more than 760,000 deaths.

Many unknowns 

Prior to Friday's decision, some outside experts had expressed misgivings over widening boosters to all adults.

The vast majority of those people becoming hospitalized or dying with COVID are unvaccinated, and the best way to control the winter wave would be to reach those people, rather than topping up the vaccinated, the critics said.

A potential downside, they argued, was that vaccine holdouts might conclude the shots are ineffective. 

Another risk is a greater number of cases of vaccine-linked heart inflammation (myocarditis), especially among younger males. Accumulating evidence shows the risk may be greater for the Moderna vaccine compared to Pfizer, likely because of its higher dose.

Both companies are conducting post-authorization studies to assess the risks of myocarditis after third shots.

Overall, however, both health agencies took the view that the benefits outweigh the risks.

It is expected that boosters, by reducing symptomatic cases, will also help reduce community transmission, though the extent to which this might happen is not known.

It is also possible that, rather than considering the third dose a booster, the vaccines work optimally when administered three times— something that will become more clear over time as data accrues. 

Experts are in broad agreement, however, that boosters alone can't resolve the pandemic while the poorest countries, especially in Africa, remain stuck in the single-digit percentages for people covered by their initial shots. 

Last week, WHO chief Tedros Adhanom Ghebreyesus decried the fact that rich countries are administering six times more vaccine doses every day than low-income countries are delivering primary doses.

This increases the risk of new variants of concern emerging in those regions, which could eventually evade the protective action of current vaccines.

Agence France-Presse

British study shows COVID-19 vaccine efficacy wanes under Delta

A British public health study has found that protection from either of the two most commonly used COVID-19 vaccines against the now prevalent Delta variant of the coronavirus weakens within three months.

It also found that those who get infected after receiving two shots of either the Pfizer-BioNTech or the AstraZeneca vaccine may be of greater risk to others than under previous variants of the coronavirus.

Based on more than three million nose and throat swabs taken across Britain, the Oxford University study found that 90 days after a second shot of the Pfizer or Astrazeneca vaccine, their efficacy in preventing infections had slipped to 75% and 61% respectively.

That was down from 85% and 68%, respectively, seen two weeks after a second dose. The decline in efficacy was more pronounced among those aged 35 years and older than those below that age.

"Both of these vaccines, at two doses, are still doing really well against Delta... When you start very, very high, you got a long way to go," said Sarah Walker, an Oxford professor of medical statistics and chief investigator for the survey.

Walker was not involved in work on AstraZeneca's vaccine, which was initially developed by immunology experts at Oxford.

The researchers would not project how much more the protection would drop over time, but suggested that the efficacy of the two vaccines studied would converge within 4-5 months after the second shot.

VIRAL LOAD

Highlighting the increased risk of contagion from the Delta variant, the study also showed that those who do get infected despite being fully vaccinated tend to have a viral load similar to the unvaccinated with an infection, a clear deterioration from when the Alpha variant was still dominant in Britain.

The Oxford findings are in line with an analysis by the U.S. Centers for Disease Control and Prevention (CDC) and come as the U.S. government outlines plans to make COVID-19 vaccine booster shots widely available next month amid a rise in Delta variant infections. It has cited data indicating diminishing protection from the vaccines over time.

Israel began administering third Pfizer doses last month to confront a surge in local infections driven by Delta. Several European countries are also expected to begin offering boosters to the elderly and people with weak immune systems.

Pfizer has said its vaccine's efficacy drops over time. Last month AstraZeneca said it was still looking into how long its vaccine's protection lasts and whether a booster dose would be needed to keep up immunity.

"The fact that we do see ... more viral load hints (...) that indeed herd immunity might become more challenging," said co-author Koen Pouwels, also of Oxford University.

Herd immunity is when a large enough portion of the population is immune to a pathogen, either by vaccination or prior infection, stopping infection numbers from growing.

"Vaccines are probably best at preventing severe disease and slightly less at preventing transmission," said Pouwels.

The authors cautioned that the viral concentration in the throat was only a rough proxy for severity of symptoms and that they had no new data on the duration of infections.

The survey, which has yet to be peer-reviewed before publication in a scientific journal, underscores concerns by scientists that the Delta variant, first identified in India, can infect fully vaccinated people at a greater rate than previous lineages, and that the vaccinated could more easily transmit it.

To contrast periods before and after Delta became prevalent, the Oxford researchers analyzed about 2.58 million swabs taken from 380,000 randomly picked adults between Dec. 1, 2020, and May 16, 2021, and 810,000 test results from 360,000 participants between May 17 and Aug. 1.

The study was conducted in partnership with Britain's Office of National Statistics (ONS) and the Department for Health and Social Care (DHSC).

-reuters

Japan sees high rate of anaphylaxis after taking Pfizer vaccine

TOKYO - People in Japan who received Pfizer Inc.'s COVID-19 vaccine seem to have suffered anaphylaxis at a higher rate than in the United States and Europe, the minister in charge of vaccination efforts said Wednesday.

Taro Kono told a parliamentary committee that 17 cases of anaphylaxis, a severe and potentially fatal allergic reaction, have been reported among the 107,558 health care workers who had been inoculated as of Tuesday.

"It's true, this seems to be more than in the United States and Europe," he said.

The rate compares with 5 cases in every 1 million doses administered in the United States and 20 cases per million in Britain, though Japan is further behind in its vaccine rollout and it could change as more people receive shots.

Japan is in the process of inoculating some 4.8 million health-care workers nationwide before expanding to people aged 65 or older in mid-April. People with pre-existing conditions such as diabetes, and those working at elderly care facilities are slated to come next.

People who take the COVID-19 vaccine developed by Pfizer and its partner BioNTech SE are being asked to remain on site for at least 15 minutes to check for anaphylaxis and other side effects.

According to the Ministry of Health, Labor and Welfare, symptoms experienced within 5 to 30 minutes of receiving a shot include sore throat, hives and difficulty breathing. All of them recovered after receiving treatment.

Health minister Norihisa Tamura has said a ministry panel plans to review the matter on Friday, looking into whether the symptoms reported in Japan were as serious as those abroad.

Pfizer has said clinical trials showed its vaccine to be 95 percent effective in preventing symptoms of COVID-19, and Prime Minister Yoshihide Suga has called inoculations the "decisive factor" in bringing the pandemic under control.

But only 63.1 percent of respondents in a Kyodo News poll conducted last month said they want to be vaccinated, with 27.4 percent saying they do not, apparently due to concerns over side effects.

Reported coronavirus cases in Japan had been falling since Suga declared a state of emergency in the Tokyo metropolitan area and other regions in January.

But the decline has bottomed out in recent weeks and the emergency declaration was extended until March 21 amid lingering worries of the strain on hospitals and the spread of more infectious variants of the virus.

Shigeru Omi, head of the government's COVID-19 subcommittee, said Wednesday the variants, first discovered in Britain, South Africa and Brazil, would also become the dominant strain in Japan "sooner or later."

"There is no question that the process to replace the existing strain has already begun," he told a parliamentary committee, stressing the need to step up efforts to monitor their spread.

-Kyodo News

First batch of Pfizer COVID-19 vaccines arrives in Canada

OTTAWA - The first COVID-19 vaccines landed on Canadian soil on Sunday, Prime Minister Justin Trudeau said, and some Canadians are expected to roll up their sleeves for a shot as soon as Monday.

Canada and the United States are set this week to become the first Western nations after the UK to begin inoculations with the newly approved vaccine.

"The first batch of doses of Pfizer-BioNTech's COVID-19 vaccine have arrived in Canada," Trudeau said on Twitter on Sunday night above a picture of a cargo plane apparently used to transport the vaccine developed by Pfizer Inc and Germany's BioNTech SE.

The initial 30,000 doses will go to 14 sites across Canada. The most vulnerable people, including the elderly in long-term care facilities and healthcare workers, will be first in line for shots.

The vaccines left Belgium, where they were produced, on Friday, and traveled to Germany and the United States before being split up and sent to different parts of Canada.

"The intent here is to ensure that we continue to have regular drip feed of vaccines in the coming weeks," with 249,000 doses expected by the end of the year, Major-General Dany Fortin, who is in charge of vaccine distribution, told the Canadian Broadcasting Corp earlier in the day.

While it is "good news" that the vaccine has arrived, Trudeau said: "Our fight against COVID-19 is not over."

Forecasting a rapid acceleration of the spread of the novel coronavirus during the second wave, Canada's federal health authorities called on Friday for provinces to impose more health restrictions heading into the holidays.

The country has had 460,743 confirmed COVID-19 cases, with 5,891 new infections reported on Sunday. On Friday, health officials said Canada could see 12,000 new cases a day by January.

The highly contagious respiratory disease has claimed 13,431 lives in Canada, including 81 on Saturday.

'BRIDGE TO RECOVERY'

"While we have a long way to go, this marks the beginning of our bridge to recovery," Procurement Minister Anita Anand said on Twitter of the vaccine arrival.

Canada is expected to approve a second vaccine from Moderna Inc "reasonably soon" and the country will be ready to accept shipments of it by the end of the week, Fortin said earlier.

Supriya Sharma, senior medical adviser at Health Canada, said on the CBC the review of the Moderna vaccine was ongoing and that important data was expected later this week.

She also outlined guidance about potential allergic reactions to the Pfizer shot after reports of two such incidents on the first day of vaccinations in Britain.

On Saturday, Canada said anyone with vaccine allergies should not take the Pfizer/BioNTech vaccine.

"If you have an allergy to a vaccine or this vaccine or any components of the vaccine, you should not get it," Sharma said. "But if you have other allergies, you can go ahead and get vaccinated."

Health Canada will be monitoring people who are inoculated for adverse reactions or side effects, she said.

Officials have said they expect to receive 6 million doses of Pfizer and Moderna vaccines before the end of March. Each vaccine requires two doses, given about three weeks apart.

-reuters-

Deadly pandemic surge in US as regulators meet on Pfizer vaccine

WASHINGTON — American regulators were due to meet Thursday to assess the Pfizer coronavirus vaccine for emergency approval, as the country logged one of its worst-ever daily COVID-19 death tolls with more than 3,000 people lost to the pandemic.

Other northern hemisphere countries were also grappling with a winter virus surge, as the number of global infections raced towards 70 million with more than 1.5 million deaths.

It is not confirmed when the US Food and Drug Administration will issue the emergency authorization for the Pfizer-BioNTech vaccine, but Health Secretary Alex Azar indicated that officials have early next week in mind.

“Now we actually get to do something that hopefully will bring this… pandemic to an end,” said Terri White, a nursing education specialist at UW Health in the state of Wisconsin, where the staff is being trained to administer the vaccine.

“I know our whole team is really excited about that prospect… to help our lives return to normal.”

Top US government scientists said, however, that people with a known history of severe allergic reactions would be asked not to take the Pfizer vaccine, following a similar warning in Britain.

The United States is the worst-hit nation in the world, with more than 15 million known infections and close to 290,000 deaths.

U.S. Army General Gus Perna, who is overseeing logistics nationwide, said he had given the order Wednesday to begin distributing syringes, needles, alcohol wipes, and dilutants required for the Pfizer vaccine, a process expected to be completed by Friday.

The next vaccines to receive approval might be those made by Moderna, Johnson & Johnson, and AstraZeneca, most likely in that order.

The U.S. hopes to vaccinate 20 million people this month, with long term care facility residents and health care workers at the front of the line. The goal is to reach 100 million by the end of February and the whole population by June.

‘I’m really excited’

After Britain gave the first approved vaccine shots in the Western world, Canada also approved the Pfizer-BioNTech vaccine on Wednesday.

The first shipments to 14 sites across Canada are scheduled to arrive Monday with people receiving shots a day or two later, according to Major-General Dany Fortin, the commander put in charge of coordinating distribution.

Healthcare workers and vulnerable populations including the elderly are to be the first to receive it.

“I’m really excited. I want to get vaccinated as soon as possible because I have a new baby,” Michelle, a Toronto resident, told AFP.

“She’s under six months old, and so obviously my main concern through the whole pandemic has been to protect her.”

Israel accepted its first shipment of the Pfizer vaccine on Wednesday, targeting a rollout on December 27, with Prime Minister Benjamin Netanyahu promising to be the first to be injected — although the vaccine has yet to pass regulatory hurdles there.

Both Russia and China have already begun inoculation campaigns with domestically produced vaccines.

‘I hope better days are coming’

As European countries eagerly await vaccines, the EU’s medical regulator was hit by a cyberattack in which documents related to the Pfizer vaccine were accessed, the firm said Wednesday.

The European Medicines Agency has promised to reach a decision on conditional approval for the Pfizer-BioNTech vaccine by December 29, with a ruling on Moderna’s candidate to follow by January 12.

But while wealthier nations have the financial and logistical abilities to roll out the vaccines, there are concerns that the poorer — and more vulnerable — parts of the world will be left behind.

African Union chairman Moussa Faki Mahamat said Wednesday that “those who have the (financial) means must not monopolize the vaccines.”

At an annual Christmas toy and food giveaway in a poor neighborhood of Belo Horizonte, Brazil, where Mrs Santa Claus embraced children from behind a plastic “hug curtain”, people hoped for an end to their suffering.

“I hope better days are coming,” said Valmira Pereira, a house cleaner. “That next year we’ll be able to give real hugs, be able to feel that human warmth that everyone’s been missing.”

Agence France-Presse

Big US firms, led by Apple, hold $2.1 trillion overseas to avoid taxes: study

WASHINGTON - The 500 largest American companies hold more than $2.1 trillion in accumulated profits offshore to avoid US taxes and would collectively owe an estimated $620 billion in US taxes if they repatriated the funds, according to a study released on Tuesday.

The study, by two left-leaning non-profit groups, found that nearly three-quarters of the firms on the Fortune 500 list of biggest American companies by gross revenue operate tax haven subsidiaries in countries like Bermuda, Ireland, Luxembourg and the Netherlands.

The Center for Tax Justice and the US Public Interest Research Group Education Fund used the companies' own financial filings with the Securities and Exchange Commission to reach their conclusions.

Technology firm Apple was holding $181.1 billion offshore, more than any other US company, and would owe an estimated $59.2 billion in US taxes if it tried to bring the money back to the United States from its three overseas tax havens, the study said.

The conglomerate General Electric has booked $119 billion offshore in 18 tax havens, software firm Microsoft holding $108.3 billion in five tax haven subsidiaries and drug company Pfizer is holding $74 billion in 151 subsidiaries, the study said.

"At least 358 companies, nearly 72 percent of the Fortune 500, operate subsidiaries in tax haven jurisdictions as of the end of 2014," the study said. "All told these 358 companies maintain at least 7,622 tax haven subsidiaries."

Fortune 500 companies hold more than $2.1 trillion in accumulated profits offshore to avoid taxes, with just 30 of the firms accounting for $1.4 trillion of that amount, or 65 percent, the study found.

Fifty-seven of the companies disclosed that they would expect to pay a combined $184.4 billion in additional US taxes if their profits were not held offshore. Their filings indicated they were paying about 6 percent in taxes overseas, compared to a 35 percent US corporate tax rate, it said.

"Congress can and should take strong action to prevent corporations from using offshore tax havens, which in turn would restore basic fairness to the tax system, reduce the deficit and improve the functioning of markets," the study concluded.

source: interaksyon.com