Novavax COVID-19 vaccine shown highly effective in trial

Novavax revealed the results of a phase three COVID-19 vaccine trial that determined that the company’s two-dose inoculation is highly effective.

The trial found the Novavax vaccine to be 90.4 percent effective overall, and 100 percent effective in protecting against moderate and severe disease.

The vaccine was also found to be 91 percent effective among high-risk populations, defined as individuals over the age of 65, or younger if they have certain comorbidities.

The results of the trial with almost 30,000 participants across 119 sites in the U.S. and Mexico aligned with the effectiveness of the Pfizer-BioNTech and Moderna vaccines, which saw 95 percent and 94.1 percent efficacies, respectively, in phase three clinical trials.

What’s next: Novavax, in a news release Monday morning, said it plans to file for regulatory authorizations in the third quarter, once the final phases of testing and process qualifications are met.

Upon approval, the company said it is on track to manufacture 100 million doses per month by the end of the third quarter, and 150 million per month by the end of the fourth quarter of this year.

“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines,” Novavax President and CEO Stanley C. Erck said.

Context: The U.S. has plenty of other vaccine options, so the future of Novavax in this country is uncertain, despite the fact that the federal government paid $1.6 billion for 100 million doses under the Trump administration’s Operation Warp Speed.

The vaccine may be put to better use overseas, especially if the FDA decides the company needs to apply for full approval or licensure, which could slow the process down even more. But even though the company likely missed its opportunity to contribute to the first wave of vaccinations in the U.S., the nation will probably need booster shots at some point in the next year.

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Biden pleads for people to get vaccinated ‘as soon as possible’

President Biden on Monday urged Americans who have not yet gotten vaccinated against the coronavirus to do so as soon as possible, pointing to the nearly 600,000 lives lost domestically from the virus.

“If you have not been vaccinated, get vaccinated. Get vaccinated as soon as possible. We have plenty of vaccinations, plenty of sites. We have more work to do to beat this virus and now is not the time to let our guard down,” Biden said.

July 4th goal in doubt: Biden has set a goal of vaccinating 70 percent of U.S. adults with at least one dose of a COVID-19 vaccine by July 4. While 13 states have reached that threshold, others are lagging behind and Biden appears increasingly unlikely to meet that goal.

Nationally, 64.5 percent of Americans above age 18 have received at least one dose of vaccine, according to the Centers for Disease Control and Prevention (CDC).

The White House has embarked on a multipronged effort to address vaccine concerns, deliver doses to hard-to-reach Americans and incentivize individuals to get their shots ove the next month.

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PM announces four-week delay to Covid lockdown easing in England

Boris Johnson says more time needed to tackle Delta variant but signals he will not tolerate further suspension

Boris Johnson announces four-week delay to England lockdown easing – video

Boris Johnson has halted the final easing of lockdown restrictions in England and ordered a four-week delay to speed up the vaccination programme, but signalled afterwards he would not tolerate any further suspension.

The prime minister said 19 July was a “terminus date” and that all restrictions on social contact could be lifted, barring the emergence of a gamechanging new variant.

The chief medical officer for England, Prof Chris Whitty, suggested that within four weeks the additional jabs would offer sufficient protection to halt a surge in hospitalisations and said there would come a point where the country would be able to live with the virus in relative normality.

But Whitty and Johnson said a speeding up of second vaccine doses for the over-40s combined with a four-week delay could prevent thousands of unnecessary deaths. Although the data will be reviewed after two weeks, No 10 said it was unlikely restrictions would change.

Johnson said the data was now clear that two doses of the vaccine were needed to combat the Delta variant, first discovered in India, and said it was right to allow extra time to give millions more people second doses.

“Now is the time to ease off the accelerator, because by being cautious now we have the chance in the next four weeks to save many thousands of lives by vaccinating millions more people,” he said.

Whitty said nobody should think that from 19 July, the risk of Covid-19 would disappear – but signalled there was a point where the risks could be managed. “There will still be … substantial numbers in hospitals and sadly there will be some people who will go on to die of this – the question is a matter of balance,” he said.

“We will have to live with this virus – which will continue to cause severe infections and kill people – for the rest of our lives.”

Johnson is likely to face a significant backlash from Conservative MPs, some of whom warned that the public was reaching its limit, though polls suggest the majority back a short delay. A senior Tory MP accused the government of shifting the goalposts from making sure the NHS is not overwhelmed to avoiding all Covid-related deaths.

“I can just about tolerate this but it’s to the end of my tolerance levels,” they said, adding ministers should know: “This is it, no more – you’re out of lives.”

But a minister dismissed grumblings from colleagues, saying there was a “huge disconnect between a minority of parliamentarians making a loud noise and mainstream opinion”.

Announcing the delay, Johnson also slashed the interval between the first and second jabs from 12 weeks to eight for the over-40s, a step that has already been taken for older adults..

 

Hospitalisations could hit the peak of the first wave if step 4 of the roadmap proceeds, according to modelling by the government’s Scientific Pandemic Influenza Group on Modelling (SPI-M) committee.

He warned that given a 50% rise in hospitalisations in the last week, if the current trajectory continued and restrictions were loosened “then we would run into trouble” fairly quickly.

Weddings will be given a limited reprieve with lifting of the cap at 30 guests, but venues must stick with social distancing requirements and table service. The advice will still prohibit singing and dancing.

The chancellor, Rishi Sunak, has rejected business demands for an extension of the furlough scheme and business rates relief as sources close to him said he believed sufficient economic support measures were already in place to cope with a delay.

Hospitalisations have risen by 50% across England, while the north-west has recorded a rise of 61%. The vast majority of patients – over 70% – admitted to hospital are under 65, while the over-65s make up fewer than 30%.

This is a “complete reversal” of the picture during the first wave, Whitty said, pointing to the success of older people having had two vaccine doses in preventing hospitalisations.

The delay of four weeks should mean all over-40s who received a first dose by mid-May will have been offered their second dose by the week commencing 19 July when the final restrictions lift, and all over-18s will have been offered a first dose. From Tuesday, all those aged 23 and over will be offered their first dose.

Minutes from the Scientific Advisory Group for Emergencies (Sage) also reveal that a four-week delay would be advantageous because it would push the easing of restrictions closer to the school holidays, when transmission of Covid is likely to be reduced.

The prime minister, who met Sunak, Matt Hancock and Michael Gove on Sunday to agree the delay, judged two of the four tests for easing restrictions had not been met – the tests that highlight the effects of new variants as well as increases in infection rates leading to possible hospitalisations and deaths.

Ahead of the decision, Gove, the Cabinet Office minister, also held a meeting of the first ministers in the devolved administrations and a cabinet call was convened. But the decision to announce the delay at a press conference provoked ire from the House of Commons Speaker, Sir Lindsay Hoyle, who said he had had to intervene to force the government to make a statement in parliament on Monday.

'Totally unacceptable': Speaker condemns sidelining of Commons over England lockdown delay – video
‘Totally unacceptable’: Speaker condemns sidelining of Commons over England lockdown delay – video

He said the prime minister making such a significant announcement at a press conference instead of in the chamber was “totally unacceptable” and that he had been “misled” into thinking no final decisions had yet been taken.

MPs are expected to vote on the change to the roadmap on Wednesday and Labour will back the change, although there is likely to be a sizeable Conservative rebellion.

Jon Ashworth, the shadow health secretary, said the delay was “predicted and predictable” and that the blame lay squarely with the prime minister. “We are here because Boris Johnson left our borders as secure as a sieve with a weak, puny border policy that allowed the Delta variant to reach our shores.”

He confirmed Labour would support the extending of restrictions to 19 July “with a heavy heart” when a vote is held in the Commons on Wednesday.

On Monday, Public Health England also released encouraging data suggesting Covid jabs appeared to offer substantial protection against hospitalisation from the Delta variant. The Pfizer/BioNTech vaccine is 94% effective against hospital admission after one dose, rising to 96% after two doses. The Oxford/AstraZeneca vaccine is 71% effective against hospital admission after one dose, rising to 92% after two.