January 29 coronavirus news

Johnson & Johnson plans to submit an application to the US Food and Drug Administration for emergency use authorization for its coronavirus vaccine next week.

The company will apply for an EUA "middle to late next week," Dr. Mathai Mammen, Janssen’s global head of research and development, said during a call with reporters on Friday morning. The call was held along with officials from the National Institutes of Health. Janssen is the vaccine arm of Johnson & Johnson. 

Once an application is submitted, "The FDA really looks very, very carefully at the data in each age group and in each demographic group," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during the call.

If the vaccine is authorized for emergency use, Mammen said, "Our plan is to have supply immediately upon launch." 

About the vaccine: Johnson & Johnson’s single-shot Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease, the company announced Friday.

The vaccine was 72% effective against moderate and severe disease in the US, the company said.

Rebecca Meyer, a previously healthy 31-year-old mom, has been battling coronavirus since March.

“We're still very much in the symptom management phase of my sickness…10, 11 months in,” Meyer told CNN’s Alisyn Camerota. 

She has been hospitalized about seven times, and usually stays two to three weeks, she said. 

“During that course, they try to run every test they can and they hit a wall at some point. And they're like, ‘do you want to be miserable in the hospital or do you want to be miserable in your bed?’ And I’d much rather be in my bed,” she said. 

Meyer said she and her family can only try to remain hopeful about the future. 

“This is our life right now. It feels like forever, but hopefully that's not the case. And that's all we can do at this point,” she said. 

Her message? Continue to take Covid-19 seriously.

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The coronavirus that causes Covid-19 will continue to evolve – but one way to prevent further mutations is to vaccinate the public, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said during a call with reporters on Friday morning.

Some context: At least four coronavirus variants have been identified. Scientists are not surprised to see the coronavirus changing and evolving — it's what viruses do, after all. And with so much unchecked spread across the US and other parts of the world, the virus is getting plenty of opportunity to do just that.

What scientists most fear is that one will mutate to the point that it causes more severe disease, bypasses the ability of tests to detect it or evades the protection provided by vaccination. While some of the new variants appear to have changes that look like they could affect immune response, it's only by a matter of degree.

Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said that he is eager to review all of the data from Johnson & Johnson’s vaccine.

Johnson & Johnson's Covid-19 single-shot vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, and 85% efficacy against severe disease, the company announced. The vaccine was 72% effective against moderate and severe disease in the US, according to the company.

��Were it me, were I not able to get the mRNA vaccine and I only had the choice of Johnson & Johnson vaccine, I would take it assuming that the data look good as we look at the FDA. I would take it in a second knowing there's probably a second-dose trial out there, which is likely to show it's even more effective,” he said. 

The data “overall are encouraging, in that it can prevent you from being hospitalized and from dying,” he added. 

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Johnson & Johnson officials praised their vaccine's 85% efficacy against severe Covid-19 during a phone call with reporters on Friday morning. The call was held along with officials from the National Institutes of Health.

"We have really good efficacy, same level of protection, across all age groups, from the very young to the middle age to the very old. We have the same efficacy across race and ethnicity," Mammen said. "This vaccine is for everyone."

Johnson & Johnson’s single-shot Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease, the company announced Friday.

The vaccine was 72% effective against moderate and severe disease in the US, the company said.

The coronavirus variant first identified in the United Kingdom is projected to soon become the dominant strain of coronavirus in Belgium, Emmanuel André, a leading microbiologist at Belgium’s National Reference Laboratory for Covid-19, said on Friday. 

“This [variant] is having a reproduction rate which is — there is still a margin of error — between 1.5 and 1.9, so there's clearly an exponential phenomenon that is starting now,” he added.

According to the National Reference Laboratory, based at KU Leuven, the UK variant could represent “about 90 percent to 95 percent” of infections in Belgium by early March. 

Pressed on whether government restrictions would be enough to stem the spread of the new variant, André noted that while current measures are “quite strict,” there is a need for them to be reinforced.

“Belgium is a small country so things can start very rapidly…we need to be very careful, or it goes up,” André warned. 

“The health system, the prevention system, the testing and tracing and so on, has continuously improved in the last year, but it's clear today that it’s not managing with this more infectious variant,” he added. 

Johnson & Johnson’s single-shot Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease, the company announced Friday.

The vaccine was 72% effective against moderate and severe disease in the US, the company said.

It’s a striking difference from vaccines from Pfizer/BioNTech and Moderna, and it may give pause to people uncertain about which vaccine to get or when they can get one. The vaccines already on the market in the US are about 95% effective overall against symptomatic Covid-19, with perhaps even higher efficacy against severe cases.

Experts say the Johnson & Johnson vaccine, developed by its vaccine arm Janssen, will still be useful against the pandemic in the United States and around the world, even if the single-dose vaccine doesn���t become the first choice for many.

For Johnson & Johnson, efficacy against moderate and severe ranged from one country to another: 72% in the US, 66% in Latin America and 57% in South Africa. This was measured from starting one month after the shot.

In South Africa, 95% of cases in the trial were due to a variant known as B.1.351, which is known to be more contagious and carries mutations that may make the virus less susceptible to the antibody immune response – including antibodies prompted by vaccination.

With that variant, “we have a lower protection against milder forms of Covid than we did in the United States, where there were more typical circulating variants,” Dr. Mathai Mammen, the company’s global head of research and development, told CNN’s Chief Medical Correspondent, Dr. Sanjay Gupta.

Even those who got moderate cases of Covid-19 in the trial tended to develop a milder course and fewer symptoms, he added.

But for Mammen, the key result was how effective the vaccine was at preventing severe disease – regardless of variant or age group.

From one month after the shot, all hospitalizations and deaths occurred in the placebo group.

The results are based on an analysis of more than 44,000 participants in eight countries, with 468 total cases of Covid-19 split between those receiving the vaccine or placebo. The results have not been published in a peer-reviewed journal, but the company said it plans to do so “in the coming weeks.”

Johnson & Johnson is expected to apply to the US Food and Drug Administration next week for emergency use authorization, which Mammen said could come by late February.

The United Arab Emirates will introduce more restrictions to fight the spread of new coronavirus variants as the country continues to record their highest daily cases, UAE officials said Friday.

The new measures include tighter restrictions on entertainment venues, more testing for incoming travelers and further limiting gatherings, the director of strategic communications at the Ministry of Foreign Affairs, Hend al Otaiba, said on Twitter.

 As other cities and countries locked down, Dubai -- which is heavily dependent on tourism -- welcomed visitors over the Christmas and New Year's holidays.

Citing the increase in Covid-19 cases, the UK on Thursday banned direct flights from the UAE, one week after deciding to shut a travel corridor between the two countries. Other countries have also imposed travel bans on the UAE, including Denmark, which temporarily suspended flights. 

The UK move came as it tightened quarantine measures in an effort to reduce Europe's worst outbreak of the virus. On Wednesday, it introduced a new hotel quarantine policy for travelers from 30 countries.

However, UK Transport Minister Grant Shapps emphasized that British, Irish and third country nationals with residence rights arriving from the United Arab Emirates would only need to isolate at home and not in a hotel.

Read more about how the UK's Covid-19 travel ban will affect the world's busiest air route here:

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German officials expect the EU's medicines regulator, The European Medicines Agency (EMA) to approve AstraZeneca’s coronavirus vaccine without age restrictions, despite a previous German recommendation that the vaccine should not be given to people over the age of 65.

Cichutek’s remarks come just a day after Germany's vaccine commission said it recommended that the vaccine developed by AstraZeneca and the University of Oxford should not be given to people aged over 65 years old due to insufficient data.

According to Germany’s Interior Ministry, Germany’s own vaccine commission, STIKO, found there is insufficient data on the “effectiveness of the AstraZeneca vaccine in people over 65 years of age.”

While the European Medicines Agency (EMA) is expected to issue its approval without restrictions, this will likely not be the case for the German vaccine commission STIKO.

Spahn added that the AstraZeneca vaccine may not be authorized in Germany for use in people aged over 65, but the government is still aiming to vaccinate all people over the age of 80 by the end of the first quarter of 2021.

So far, Germany has administered the coronavirus vaccines developed by Pfizer/BioNTech and Moderna. 

Some background:

As of Friday, according to Germany's health agency the Robert Koch Institute (RKI), 3.5 million coronavirus vaccines have been distributed across the country with 2.4 million vaccinations administered.

But as the EU experiences a vaccine shortfall, Spahn warned Germany too should expect "some weeks" of shortages.

RKI head Lothar Wieler told journalists on Friday that although Germany is “on a good path,” with infection numbers declining, more cases of new coronavirus variants are being confirmed, putting increased pressure on the country’s hospitals. 

According to RKI, 14,022 new coronavirus cases have been confirmed in Germany as of Friday, bringing the country’s total number of cases reported since the beginning of the pandemic to 2,192,850.