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CORONA VIRUS

‘Most People Don’t Need Covid Vaccine Booster’, Scientists Say

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Covid-19 vaccines work so well that most people don’t yet need a booster, an all-star panel of scientists from around the world said in a review that’s likely to fuel debate over whether to use them.

Governments would be better served to focus on immunizing the unvaccinated and to wait for more data on which boosters would be most effective and at what doses, the authors, who included two prominent U.S. Food and Drug Administration experts, argued in the medical journal The Lancet.

They based their assessment on a wide range of real-world observational studies as well as data from clinical trials.

“None of the studies has provided credible evidence of substantially declining protection against severe disease,” the authors wrote. There could also be additional side-effect risks if boosters are introduced too soon or too broadly, they said.

Most countries with ample vaccine supplies are debating whether to allocate doses for booster shots to prop up immunity and potentially help stop the spread of the more infectious delta variant.

The U.S. plans to roll out booster shots starting Sept. 20, though the proposal still needs sign-off from the FDA and the Centers for Disease Control and Prevention.

Scientists are by no means unanimous on the topic of boosters. Even a small reduction in efficacy against the spread of Covid can strain a health-care system, and “there is therefore no ‘one size fits all’ approach,” said Azra Ghani, chair in infectious disease epidemiology at Imperial College London, who wasn’t involved with the review.

Shares of vaccine makers fell after the review was published. BioNTech SE’s American depositary receipts fell as much as 7.7%, the biggest intraday decline in almost a month, while partner Pfizer Inc. dropped as much as 2.5%. Moderna Inc. also lost as much as 7.7% as of 11:12 a.m. in New York, and AstraZeneca Plc. slipped as much as 1.2% in London.

The analysis is a blow to President Joe Biden, who announced his booster program in August after an extraordinary joint statement from his top medical advisers, including CDC Director Rochelle Walensky, Anthony Fauci, the longtime head of National Institutes of Allergy and Infectious Diseases, and FDA Acting Commissioner Janet Woodcock.

Biden’s advisers said then that the data supported the need for boosters and that they would begin preparing for them, noting that regulators would still need to sign off on the plan.

Some experts have questioned the need for the extra shots, while the World Health Organization has called for a moratorium on them until more people outside of rich countries can get protection.

A U.K. government advisory panel is set to soon recommend whether to move forward with broad use of a third vaccine dose.

Britain is already offering boosters to those with severely weakened immune systems, as are many European Union countries. The European Medicines Agency is also reviewing booster data from Pfizer and BioNTech, and from Moderna Inc.

Among the scientists behind the Lancet article were Marion Gruber, who leads the FDA’s Office of Vaccines Research and Review, and her deputy Philip Krause. Both have said they would step down later this year.

Gruber and Krause were two of a group of FDA staff who last year pushed back against pressure by the Trump administration to speed up the authorization of the Covid vaccines, according to a person familiar with the matter.

The WHO’s Soumya Swaminathan, Ana-Maria Henao-Restrepo and Mike Ryan also worked on the review.

The WHO said it would make better public-health sense to focus on immunizing those who haven’t gotten any shots yet — whether because of anti-vaccine sentiment in countries with ample reserves, or because they live in places with little access to shots.

“Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations,” the authors wrote.

Across the observational studies done so far, vaccination has shown an average of 95% effectiveness against severe disease, including against more infectious variants such as delta, and more than 80% effective at preventing any infection, the review found.

Even in countries with high vaccination rates, it’s unvaccinated people who are driving transmission of the virus — and who are at highest risk of becoming very ill, the study found.

 

Bloomberg

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CORONA VIRUS

President Tshisekedi Finally Takes Covid-19 Vaccine Jab

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Until DRC lost 1,068 citizens and 56,096 recorded cases to the deadly Covid-19 since its emergence in the country last year, President Félix Tshisekedi had not taken a vaccine jab.

On Sunday, Tshisekedi rolled up his sleeve on his left hand to allow a physician sink into his flesh a syringe containing the covid-19 vaccine.

Meanwhile, on the same occassion on Sunday, the DRC First Lady Denise Nyakeru also took her first Covid-19 vaccine before cameras.

However, the name of the vaccine was not released, but the Presidential Press noted that immediately after being vaccinated, Tshisekedi reiterated his support for the vaccination.

“The vaccine remains the best-indicated solution for the time being in the face of COVID-19,” President Tshisekedi said after taking his first dose at the UA city presidential clinic in Kinshasa.

The presidential couple thus launched the second phase of the national anti-Covid19 vaccination campaign.

Dr Roger Kamba, Special Advisor of the PR in charge of universal health coverage, confirmed the presence in the DRC of more than 250,000 doses of the Moderna vaccine as well as the imminent arrival of several thousand doses of the Johnson & Johnson, Astra vaccines. zeneca and Pfizer.

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CORONA VIRUS

Study Shows Moderna Creates Twice as Many Antibodies as Pfizer

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Moderna Inc.’s Covid vaccine generated more than double the antibodies of a similar shot made by Pfizer Inc. and BioNTech SE in research directly comparing immune responses to the inoculations.

A study of almost 2,500 workers at a major Belgium hospital system found antibody levels among individuals who hadn’t been infected with the coronavirus before getting two doses of the Moderna vaccine averaged 2,881 units per milliliter, compared with 1,108 units/mL in an equivalent group who got two jabs of the Pfizer shot.

The results, published Monday in a letter to the Journal of the American Medical Association, suggested the differences might be explained by the:

higher amount of active ingredient in the Moderna vaccine — 100 micrograms, versus 30 micrograms in Pfizer-BioNTech

longer interval between doses of the Moderna vaccine — four weeks, versus three weeks for Pfizer-BioNTech

Moderna’s vaccine was associated with a two-fold risk reduction against breakthrough SARS-CoV-2 infections compared to Pfizer’s in a review of people in the Mayo Clinic Health System in the U.S. from January to July.

The results were reported in a separate study released ahead of publication and peer review on Aug. 9.

 

Bloomberg

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CORONA VIRUS

Doctors Without Borders Calls For Fair Access Following US Approval Of Pfizer Vaccine

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Following Monday’s full approval of the Pfizer-BioNTech mRNA COVID-19 vaccine by the US Food and Drug Administration (FDA), Médecins Sans Frontières/Doctors Without Borders (MSF) called again on Pfizer and BioNTech to immediately share the vaccine technology and knowledge with manufacturers on the African continent that could help boost global vaccine supply.

They should do this via the World Health Organization’s (WHO) mRNA vaccine technology transfer hub hosted in South Africa.

With only 1.7% of Africa’s population fully vaccinated against COVID-19, increasing and diversifying production and supply of mRNA vaccines through additional manufacturers, beginning with those based in countries on the African continent, offers an opportunity to urgently and sustainably address vaccine inequity during this pandemic, and in the future.

“Setting up mRNA vaccine manufacturing capacity in Africa is absolutely possible. Our analysis shows that at least seven manufacturers in African countries currently meet the prerequisites to produce mRNA vaccines, if all necessary technology and training were openly shared,” said Lara Dovifat, Campaign Manager, MSF Access Campaign.

“In fact, since July 2020, we’ve observed Pfizer-BioNTech and Moderna facilitate mRNA vaccine production with manufacturers in Switzerland, Spain and Germany, all within 8 months, so it is clearly feasible for other manufacturers to swiftly produce mRNA vaccines. The only reason these vaccines aren’t being produced more widely is because Pfizer-BioNTech and Moderna are refusing to share mRNA vaccine technology and information with manufacturers—including those in Egypt, Morocco, South Africa and Tunisia that could have the capacity to produce up to 100 million doses annually within a 10-month timeframe.”

In an analysis by Imperial College of London commissioned by MSF, the estimated total cost needed for starting up mRNA vaccine manufacturing in an existing manufacturing site and producing 100 million doses is approximately US$127 million for BioNTech-Pfizer’s vaccine and US$270 million for Moderna’s vaccine.

Considering the estimated US$2.5 billion of public money that has gone into the development of mRNA vaccines, and the forecasted 2021 sales revenues of $26 billion and US$19 billion for Pfizer-BioNTech and Moderna, respectively, these companies have a public obligation to facilitate increasing vaccine production and supply wherever possible.

Currently, only 1% of Pfizer-BioNTech vaccine doses have been delivered to low-income (0.1%), and low- and middle-income countries (0.9%).

Given that countries in Africa historically import 99% of the vaccines they administer, such vaccine dependence is clearly not sustainable for a continent of 1.2 billion people.

“As we’re seeing in the places we work, being almost entirely dependent on erratic vaccine imports and donations has so far proven woefully insufficient for vaccine access on the African continent,” said Dr Khosi Mavuso, Medical Representative for MSF in South Africa.

As new variants emerge and people continue to die from COVID-19 at alarming rates across Africa, the vaccine shortages we’re seeing are incredibly concerning.

He added that this suffering could be alleviated if pharmaceutical companies shared the mRNA technology and know-how needed to produce more COVID-19 vaccines now, through the WHO technology transfer hub, so that local vaccine production can begin as soon as possible.

“It is a failure for global public health that governments and mRNA vaccine producers are not doing everything they can to scale up production of COVID-19 vaccines when there are potential manufacturers on the African continent,” he said.

mRNA vaccines are a revolutionary and lifesaving new medical tool that are an advantageous choice for use and manufacturing in low- and middle-income countries – they are relatively simpler, faster and cheaper to produce than traditional vaccines; relatively easy to scale up production; and highly adaptable to new variants.

In addition, mRNA technology can be adapted to target other pathogens, meaning the same platform can be ‘switched’ to produce different vaccines or even therapeutics for other diseases of concern, including for preparedness for future pandemics.

“Supporting sustainable, independent vaccine manufacturing capacity in an African country would only require technology transfer from Pfizer-BioNTech and Moderna, but would be a gamechanger for equitable access to vaccines for people in low- and middle-income countries,” said Dr Carrie Teicher, Director of Programs, MSF-USA.

“The US government must immediately urge Pfizer-BioNTech and Moderna to share the COVID-19 mRNA vaccine technology and know-how. It really is a no-brainer – sharing mRNA technologies will increase the global production and supply of COVID-19 vaccines, saving lives in this pandemic and in the future.”

 

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