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Positive news on COVID vaccines weighs against concerns over new variants

Ciara Linnane

California records more than 50,000 COVID deaths to lead U.S. fatalities

The COVID-19 vaccine developed by Pfizer Inc. and German partner BioNTech SE has proved to be as effective in the real world as it was in clinical trials in the first major study of the two-dose regiment involving 1.2 million people in Israel.

The data was peer-reviewed and published in the prestigious New England Journal of Medicine on Wednesday, (link)and found the vaccine cut symptomatic cases of COVID by 94% across all agree groups. It also reduced severe illness by 92%, according to the authors.

"This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19--related outcomes, a finding consistent with that of the randomized trial," the authors wrote.

The news comes as Pfizer (PFE) and BiotNTech (BNTX) said they would test a third dose of their vaccine (link)to see whether a booster is effective in dealing with new variants of the virus, that have emerged in the U.K., Brazil and South Africa, and that are now circulating in the U.S. and elsewhere.

"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 Chief Executive Albert Bourla. "This booster study is critical to understanding the safety of a third dose and immunity against circulating strains."

A U.S. Food and Drug Administration advisory committee will review Johnson & Johnson's (JNJ) single-dose COVID-19 vaccine at a special meeting on Friday and then vote on whether they believe the benefits of the vaccine outweigh the risks. The FDA said Wednesday the vaccine had showed no unexpected safety concerns, (link)bolstering hopes it will receive an emergency authorization and offer doctors further ammunition in dealing with the crisis.

A new variant of the virus, that is being called B.1.526 has been uncovered in New York City, according to the New York Times, (link)and it carries a mutation that may undermine the effectiveness of vaccines. The newspaper cited two separate teams of researchers, one based at Caltech (link) and another at Columbia University that have detected the new variant. The former posted its study online on Wednesday, while the Columbia team has submitted theirs to a preprint server and it's not yet public.

Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told NBC's Today show that mutations will arise in greater numbers unless people are vaccinated.

"This is a race between the virus and getting vaccines into people," Fauci said. "The longer someone waits to get vaccinated, the better chance the virus has to get a variant or a mutation. So the sooner we get vaccine into the arms of individuals, whatever that vaccine is, once it gets by the FDA, if it's available to you, get it."

As regards the new strain in New York City, Fauci said such variants will arise. "The trick is when they do occur, to prevent them from spreading," he said.

Fauci also offered an update on a new U.S. initiative to study so-called COVID "long-haulers," those patients who have been left with sometimes crippling symptoms months after recovery. A study published last week in the Journal of the American Medical Association (link) found that about 30% of COVID-19 patients report symptoms they cannot shake for up to nine months after falling ill.

"We don't understand that syndrome very well," said Fauci, who is also President Joe Biden's chief medical officer.

"That's the reason why we're developing large cohorts of people to follow them and find out what the extent of it is, what the duration of it is, and what we call pathogenesis, what is the mechanism of why people have extreme fatigue, muscle aches, temperature disregulation, sleep disorders and something they call brain fog, which really means they have difficulty focusing or concentrating. It's something that we have to look at very carefully and we are."

About $1.5 billion in funding has been provided to finance the study.

The U.S. added 70,768 new COVID cases on Wednesday, according to New York Times tracker, (link) and at least 3,210 people died. Cases are steadily falling, however, and have averaged 68,123 a day in the past week, down 35% from the average two weeks ago.

There were 54,118 COVID patients in U.S. hospitals on Wednesday, according to the COVID Tracking Project, (link) down from 55,058 a day earlier and the lowest level since Nov. 5. Hospitalizations are now down 59% from their January peak.

On the vaccine front, the Centers for Disease Control and Prevention's vaccine tracker (link) is showing that as of 6.00 a.m. Wednesday, 88.7 million doses had been distributed to states, 66.5 million doses had been administered and 45 million people had received at least one dose.

In other news:

-- GlaxoSmithKline (GSK.LN) said its experimental monoclonal antibody treatment did not meet the primary endpoint in a mid-stage trial evaluating its use in hospitalized COVID-19 patients of all age groups, MarketWatch's Jaimy Lee reported (link). As part of the study's design, the therapy, otilimab, was given in addition to the standard of care, which includes treatments such as Gilead Sciences Inc.'s (link)(GILD) antiviral Veklury. GSK said it would now refocus the study on patients older than 70 years old, with plans to enroll 350 people who fit this demographic, after data from that study indicated the antibody treatment was more likely to improve outcomes for older patients. GSK said it plans to publish the details of the initial Phase 2 trial in a preprint.

-- President Biden and Vice President Kamala Harris will mark the 50 millionth vaccine shot in the U.S. later Thursday with a White House event.


-- Altimmune Inc. (link)(ALT) were down 4.8% in trading on Thursday after the company said it started enrolling participants in a Phase 1 clinical trial for its COVID-19 vaccine candidate. Altimmune is developing a single-dose nasal spray vaccine. The study is expected to enroll up to 180 healthy adults between the ages of 18 and 55 years old, who will receive one of three doses of the experimental vaccine. The company said it expects to share the first batch of clinical data from this trial in the second quarter of this year.

-- Regeneron Pharmaceuticals Inc. (REGN) said an independent committee recommended the placebo no longer be given to COVID-19 patients in a Phase 3 clinical trial because the company's antibody cocktail demonstrated "clear" efficacy. The committee said the treatment, REGEN-COV, which received emergency authorization in November, reduced hospitalizations and deaths at two dose levels, and it would continue to enroll non-hospitalized COVID-19 patients who will receive either dose of the therapy. The company said it plans to share detailed clinical data from the trial next month as part of its effort to secure a full approval from the Food and Drug Administration for the antibody cocktail.

-- Finland will enter a three-week lockdown starting March 8 as it works to contain a rising number of COVID cases, Reuters reported (link). The Nordic country has been widely admired for its success in reining in the pandemic last spring when it was circulating elsewhere in Europe. Prime Minister Sanna Marin said she is ready to declare a state of emergency next week, having discussed this with the president. Among other things, a state of emergency would allow closing restaurants, requiring healthcare workers to work longer hours and cancel their holidays. Finland has had 55,687 confirmed cases of COVID, according to data aggregated by Johns Hopkins University, (link)and 737 deaths.

Latest tallies

The global tally for confirmed cases of the coronavirus that causes COVID-19 climbed above 112.6 million on Thursday, the Johns Hopkins data shows, and the death toll rose above 2.49 million.

At least 63.5 million people have recovered from COVID.

The U.S. has the highest case tally in the world at 28.3 million and the highest death toll at 505,899, after surpassing the 500,000 level late Monday. There was bad news from California, which has recorded more than 50,000 fatalities, the most of any state.

Brazil has the second highest death toll at 249,957 and is third by cases at 10.3 million.

India is second worldwide in cases with 11 million, and now fourth in deaths at 156,705.

Mexico has the third highest death toll at 182,815 and 13th highest case tally at 2.1 million.

The U.K. has 4.2 million cases and 121,979 deaths, the highest in Europe and fifth highest in the world.

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02-25-21 1126ET

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