Coronavirus Latest: J&J Single Shot Vaccine Effective, Biden Lauds 50m Vaccinated, World Stats

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Johnson & Johnson’s single-dose coronavirus vaccine is effective at preventing moderate and severe cases of COVID-19, according to an analysis of the trial data published by the Food and Drug Administration on Wednesday.

The company’s single dose vaccine is 66 percent effective, well within the agency’s standards. The vaccine is also safe to use, according to the analysis.

More specifically, the vaccine is more than 85 percent effective at preventing severe cases of COVID-19 and completely prevents hospitalizations and deaths.

Overall, there were seven deaths in the trial, all in the placebo group.

The company initially announced the 66 percent effectiveness in a press release last month but had not yet released trial results.

The information was published ahead of an FDA advisory committee meeting Friday, which will debate whether to grant the vaccine emergency authorization. The promising data gives hope that a third coronavirus vaccine could be authorized as soon as this weekend.

While the other coronavirus vaccines already on the market may appear to be more effective than Johnson & Johnson’s, experts say it is difficult to compare them head-to-head.

The vaccine was tested in a 44,000-person clinical trial across the U.S., Brazil and South Africa geographic regions, all of which have seen mutated versions of the virus.

There was a lower efficacy against moderate to severe/critical disease endpoints observed in South Africa compared to the United States and Brazil, but vaccine efficacy against severe or critical COVID-19 infections was “similarly high in all 3 countries,” the review found.

Still, the varying efficacy is a warning sign about mutations, especially from the variant found in South Africa. The effectiveness against moderate to severe illness dropped from 72 percent in the United States to 57 percent in South Africa, where a new coronavirus variant is prevalent.

The vaccine was less effective in a subgroup of adults older than 60 with underlying conditions, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines.

The most frequently reported local adverse reaction was injection site pain, which was reported more by younger participants aged 18 to 59 than people older than 60.

If granted authorization, the U.S. won’t see a significant increase in available vaccine supply. Johnson & Johnson has said it will have about 4 million doses ready to ship immediately upon emergency authorization. A company executive told Congress that it expects to provide 20 million doses by the end of March and 100 million by summer.

However, the shot could ease the complicated logistics of the U.S. vaccine rollout. Unlike the vaccines from Moderna and Pfizer, Johnson & Johnson’s shot can be stored in a normal refrigerator for several months, rather than at ultra-cold temperatures.

And as a single shot, there won’t be a concern about scheduling or having enough supplies for a second dose.

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Biden marks 50 million coronavirus vaccines but warns virus fight not over

President Biden on Thursday marked the 50 millionth coronavirus vaccine shot delivered in the United States and said the country was making progress in defeating the pandemic and returning to normal life.

But he also warned Americans not to let their guard down.

Biden said the vaccine count marked major progress toward reaching and surpassing his administration’s goal of getting 100 million shots in the arms of Americans in his first 100 days in office. 

“Today, I am here to report we are halfway there. Fifty million shots in just 37 days since I have become president. That is weeks ahead of schedule, even with the setbacks we faced during the recent winter storms,” Biden said in the South Court Auditorium Thursday afternoon. 

“We are moving in the right direction, though, despite the mess with inherited from the previous administration, which left us with no real plan to vaccinate all Americans,” Biden said, echoing other administration officials who have characterized the Trump administration’s vaccination plan as insufficient.

Coming next: Biden celebrated the news that the Food and Drug Administration (FDA) analysis found Johnson & Johnson’s single-dose coronavirus vaccine to be effective, but promised not to put “political pressure” on the FDA to grant emergency use authorization for the vaccine. 

“If the FDA approves the use of this new vaccine, we have a plan to roll it out as quickly as Johnson & Johnson can produce it,” Biden said.

An FDA advisory committee will meet tomorrow to vote on recommending the vaccine for authorization.

Vaccine rollout: It’s going faster than 1 million shots a day, which was what most people expected to happen when Biden first announced his 100 million shots goal. Barriers remain, and while supply is expected to increase, there are numerous potential hiccups in the fragile supply chain that could slow the effort. 

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Pfizer to study booster shot aimed at virus variant

Both Pfizer and Moderna have now laid out strategies for adapting vaccines for the variants. 

Pfizer is studying whether a third shot, 6 to 12 months later, will fight the variants, avoiding the need for an updated vaccine. But it’s working on an updated vaccine too, just in case. 

“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine,” said Pfizer CEO Albert Bourla.

Moderna said Wednesday that it has sent doses of an updated vaccine against the South African variant to the National Institutes of Health for study.

In more Pfizer news, it will also be easier to store that vaccine, as the FDA approves storage at standard freezer temps

The Food and Drug Administration on Thursday approved storing Pfizer’s COVID-19 vaccine at standard freezer temperatures, helping ease storage requirements that could make delivery of the vaccine easier. 

The Pfizer vaccine had previously been required to be stored in ultra-cold freezers at -112º F to -76º F. That posed a challenge for distribution of the vaccine in rural areas or lower income countries that do not have widespread ultra-cold storage capability. 

The new move will allow the vaccine to be stored at “conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.”

“This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions,” Peter Marks, a top FDA vaccine official, said in a statement.

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Moderna forecasts $18bn in sales of Covid vaccine this year

Better than expected revenues will push US firm founded in 2010 into profit for first time

Moderna vaccines in box
Moderna said it was in discussions with several governments about more vaccine orders. Photograph: Paul Sancya/AP

 

Moderna expects to rake in $18.4bn (£13bn) of sales from its coronavirus vaccine this year, marking a huge turnaround in the fortunes of the US biotech firm.

The expected revenue is far higher than the $11.2bn predicted by analysts, and exceeds the $15bn in sales that its US rival Pfizer expects for the Covid-19 vaccine that it developed with Germany’s BioNTech.

Massachusetts-based Moderna, founded 11 years ago, said the final number could even exceed the $18.4bn its current deals would bring in, as it was in discussions with several governments about further orders. It is also in talks with Covax, a mechanism created to distribute Covid vaccine doses fairly around the world.

The vast sales will push Moderna into profit for the first time and move the company into a bigger league. The UK’s AstraZeneca had sales of $25bn last year, but while AZ employs 70,000 staff, Moderna had just 830 in 2019.

Moderna charges $30 for the required two shots in the US and $36 in the EU. By comparison, the Pfizer/BioNTech vaccine costs $39 for two doses in the US and just under $30 in the EU. The AstraZeneca vaccine ranges from $4.30 to $10 for two doses, and the company had pledged not to profit from the vaccine until the pandemic is declared over.

The Moderna vaccine, similar to the Pfizer/BioNTech version, is based on re-engineering mRNA – the molecule that sends genetic instructions from DNA to a cell’s protein-making machinery – and it has produced equally strong results in late-stage clinical trials, with an efficacy of 94%.

Moderna is the first company to have developed a new vaccine version designed to provide better protection against the highly contagious coronavirus variant identified in South Africa, and it shipped it to the US National Institutes of Health this week for testing as a booster shot.

Stéphane Bancel, the chief executive of Moderna, said 2021 would be “an inflection year” for the business. The 48-year-old Frenchman has been at the helm of Moderna since 2011.

The company floated in 2018 but the share price languished around the flotation price until coronavirus emerged. In the last 12 months, the price has soared from around $19 to $155, giving the company a value of around $60bn. That surge has turned Bancel, who has a 9% stake in Moderna, into a paper billionaire worth more than $5bn.

The firm opened subsidiaries in eight countries last year and plans to add Japan, South Korea and Australia in 2021. “We will advance our mission of delivering on the promise of mRNA science to create a new generation of transformative medicines for patients,” Bancel said. “This is just the beginning.”

Moderna was founded in 2010 by a stem cell biologist, Derrick Rossi, and two financial backers, with the idea that mRNA could be re-engineered to develop drugs and vaccines. It has 23 other mRNA drugs and vaccines in its portfolio, such as vaccines for the viruses Zika, HIV and Nipah. But with the exception of the Covid-19 vaccine, none of its products have yet made it to market.

The UK has ordered 17m shots of the Moderna vaccine, the first of which are expected to arrive in April. The EU has already received some Moderna jabs. Last week the EU ordered 150m additional doses from Moderna, for delivery from the summer, bringing its total order this year to 310m doses. It has the option to purchase a further 150m doses for delivery next year.

Two weeks ago the US government purchased an additional 100m doses of the Moderna vaccine, taking its total to 300m doses. Moderna remains on track to deliver the first 100m doses by March and the second order of 100m doses in May. Japan has purchased 50m do

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COVID-19 CORONAVIRUS PANDEMIC
Last updated: February 26, 2021, 09:03 GMT
Graphs – Countries – News

Coronavirus Cases:

113,597,323

Deaths:

2,520, 298
Highlighted in green
= all cases have recovered from the infection
Highlighted in grey
= all cases have had an outcome (there are no active cases)

 

A MESSAGE FROM CONSUMERS FOR QUALITY CARE

Research shows that consumers want lower health insurance costs, more predictability, greater equity, and comprehensive, quality care. Read CQC’s Negotiators Guide to Health Care Reform: consumers4qualitycare.org/research

 

 

Senate health committee considers two more Biden picks 

The Senate health committee on Thursday considered Rachel Levine, Biden’s nominee to be the assistant secretary for health, and Viviek Murthy, the president’s pick to be surgeon general.

Both appear likely to be confirmed by the Senate, with Democrats holding 50 seats and Vice President Harris on hand to break any ties. 

While most Republicans had questions about the professional experiences of the nominees, and how they would approach COVID-19, mental health and other public health issues, Sen. Rand Paul (R-Ky.), an ophthalmologist, equated genital mutiliation to gender-affirming surgery while questioning Levine, who is transgender.

“It is really critical to me that our nominees be treated with respect and that our questions focus on their qualifications and the work ahead of us, rather than ideological and harmful misrepresentations like those we heard from Senator Paul earlier,” said Sen. Patty Murray (D-Wash.), health committee chairwoman, responding to his remarks.

Read more here.

 

DC vaccine sign-ups plagued with technical problems

COVID-19 vaccination sign-ups in Washington, D.C., on Thursday morning ran into technical problems, causing frustration for people trying to secure appointments on the first day of eligibility for people under 65 with underlying conditions. 

The city made appointments available on Thursday for the first time for people 18 and older who have a range of underlying conditions that put them at higher risk from COVID-19, and live in priority zip codes.

But residents reported frustrating delays in getting through online. When some people got through, they reported getting messages that they were not eligible, even though they were. 

The message some received appeared not to be updated to reflect the new eligibility for people with underlying conditions, saying that vaccinations were only for those over 65 or people in certain occupations. 

It was a scenario familiar to most people across the country who have tried to navigate their states’ online signup systems for vaccines.

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