Coronavirus treatment weeks away, drugmaker says

Pfizer says early analysis shows its Covid-19 vaccine is more than 90% effective

Coronavirus treatment weeks away, drugmaker says

(CNN)Drugmaker Pfizer said Monday an early look at data from its coronavirus vaccine shows it is more than 90% effective — a much better than expected efficacy if the trend continues.

The so-called interim analysis looked at the first 94 confirmed cases of Covid-19 among the more than 43,000 volunteers who got either two doses of the vaccine or a placebo. It found that fewer than 10% of infections were in participants who had been given the vaccine. More than 90% of the cases were in people who had been given a placebo.

Pfizer said that the vaccine, made with German partner BioNTech, had an efficacy rate higher than 90% at seven days after the second dose, which means protection is achieved 28 days after a person begins vaccination. The vaccine requires two doses. The US Food and Drug Administration has said it would expect at least 50% efficacy from any coronavirus vaccine.

In an interview with CNN Chief Medical Correspondent Dr. Sanjay Gupta on Monday morning, Pfizer CEO Albert Bourla called the Covid-19 vaccine “the greatest medical advance” in the world's last hundred years.

“Emotions are very high. You can imagine how I felt when I heard the results yesterday at 2 p.m. I think that ly, impact, this will be the greatest medical advance in the last 100 years,” Bourla said.

“It is extraordinary but it's coming at a time that the world needs it the most,” Bourla said, noting that the United States has recently seen more than 100,000 daily new Covid-19 cases.

In a news release, the pharmaceutical giant said it plans to seek emergency use authorization from the FDA soon after volunteers have been monitored for two months after getting their second dose of vaccine, as requested by the FDA.

Pfizer said it anticipated reaching that marker by the third week of November.

In a text message to CNN, Dr. Anthony Fauci called Pfizer's results “Extraordinarily good news!”

Fauci, director of the National Institute of Allergy and Infectious Diseases, said he has not seen the vaccine data himself, but he spoke to Bourla Sunday night.

More results to come

There's still more to learn about the Pfizer vaccine.

The Phase 3 trial of the Pfizer vaccine has enrolled 43,538 participants since July 27. As of Sunday, 38,955 of the volunteers have received a second dose of the vaccine. The company says 42% of international trial sites and 30% of US trial sites involve volunteers of racially and ethnically diverse backgrounds.

The final goal of the trial is to reach 164 confirmed cases of coronavirus infection.

The Pfizer vaccine uses a never-before-approved technology called messenger RNA, or mRNA, to produce an immune response in people who are vaccinated.

The mRNA vaccine approach uses genetic material called mRNA to trick cells into producing bits of protein that look pieces of the virus. The immune system learns to recognize and attack those bits and, in theory, would react fast to any actual infection.

Pfizer said Monday it will evaluate whether the vaccines protects people against severe Covid-19 disease and whether the vaccine can provide long-term protection against Covid-19 disease, even in patients who have been infected before.

“How long this protection lasts is something we don't know,” Bourla told CNN.

It's not clear whether the Covid-19 vaccine will become a yearly or season shot, but Bourla believes it's ly.

“I think it is a ly scenario that you will need periodical vaccinations,” Bourla told Gupta. “The reason why we selected the RNA technology was exactly that. This is a technology that you can boost without problems of creating antibodies against your vaccine, again and again and again.”

So far, the vaccine hasn't shown any safety concerns, Bourla said.

“What we know right now — it is with very, very high level of confidence these are very highly effective vaccines. What we know so far, it means that we don't have any safety concerns, but we need to wait until the results are there,” Bourla said.

More than a billion doses expected in 2021

Bourla told CNN that Pfizer expects to have 50 million vaccine doses globally this year, and 1.3 billion next year.

“Who will get this vaccine? We have two separate manufacturing lines. One is in the US,” Bourla said. “Those we prefer using mainly for Americans.”

Bourla added that a second line in Europe will be used to produce vaccines for the rest of the world. “We have already signed contracts with multiple governments in the world and they have placed orders,” Bourla said.

The vaccine will be free to all American citizens, Bourla said.

Pfizer's vaccine was not developed as part of Operation Warp Speed, the US government's coronavirus vaccine effort.

The federal government has invested $1.95 billion in Pfizer's vaccine to help it manufacture a billion doses or more by next year, but it is not helping to test it and Pfizer has said it will distribute the vaccine itself.

President-elect Joe Biden said in a statement the Pfizer announcement is “excellent news,” but warned that mask wearing and social distancing are still necessary.

President Donald Trump, who had previously suggested a vaccine might come before Election Day, said in a tweet that the Pfizer announcement was “SUCH GREAT NEWS!” and noted the stock market was up.

When asked on Monday about the timing of the Pfizer announcement — just days after the election — Bourla said, “the science brought it exactly at this time.”

“We announced it the moment we learned about it, and I said multiple times the election for us is an artificial timeline,” Bourla said. “This is when science brought it to us.”

CNN's Maggie Fox, Jamie Gumbrecht, Jacqueline Howard and Andrea Diaz contributed to this report.

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Источник: https://www.cnn.com/2020/11/09/health/pfizer-covid-19-vaccine-effective/index.html

The race to find a coronavirus treatment: One strategy might be just weeks away, scientists say

Coronavirus treatment weeks away, drugmaker says
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Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

MILWAUKEE – In a week when the coronavirus closures and quarantines hit  falling dominoes – the lockdown in Italy, the empty workplaces and college campuses in the U.S., suspended sports seasons, canceled festivals – far less attention fell on the global scientific community's drive to find treatments for the new virus. 

But researchers are already suggesting strategies to help patients suffering from the virus, which is marked by fever, coughing and difficulty breathing. One treatment could be just weeks away.

With no vaccine expected anytime soon, treatments are crucial to saving the lives of thousands of the infected, especially high-risk patients – the elderly, those with compromised immune systems and those with chronic illnesses, such as diabetes, heart disease and lung disease. 

“I'm very hopeful and very positive. We'll get through this,” said Robert Kruse, a doctor in the Department of Pathology at Johns Hopkins Hospital in Baltimore. “I've been shocked this week at the measures that have been taken (to alter daily life). They were probably the correct ones, given that they have worked in other countries.”

'Time is of the essence'

Kruse has been pursuing two treatment strategies, one of which has a long history and could be available within weeks rather than months. The quickest option is ly to be the use of antibodies from recovered COVID-19 patients. As of Saturday, there were almost 72,000 such patients worldwide. The virus has infected about 150,000, killing more than 5,500.

The use of survivor antibodies, serum therapy, dates back to 1891 when it was used successfully to treat a child with diphtheria. Since then, serum from recovered patients has been used “to stem outbreaks of viral diseases such as poliomyelitis, measles, mumps and influenza,” according to a paper Friday in The Journal of Clinical Investigation.

“As we are in the midst of a worldwide pandemic, we recommend that institutions consider the emergency use (of serum from recovered patients) and begin preparations as soon as possible. Time is of the essence,” wrote the paper's two authors, Arturo Casadevall of Johns Hopkins School of Public Health and Liise-anne Pirofski of the Albert Einstein College of Medicine in New York.

All of the strategies, including the use of serum from recovered patients, have drawbacks. Transfusion of serum carries potential side effects, including fever, allergic reactions and a very small risk of infectious disease transmission. 

Collecting large amounts of serum from recovered patients could be a sizable task. It could turn out that serum from one recovered patient is enough to save only a single sick one, explained Kruse at Johns Hopkins. “It's a logistical challenge to put it together, but at the very least there are no hurdles (from the U.S. Food and Drug Administration) to producing the therapy.”

Kruse advanced another technique in a paper published in late January in the journal F1000 Research.

His method seeks to take advantage of the new coronavirus' ability to latch onto and enter cells.

Scientists often talk about “cell receptors,” which are essentially doors that allow a virus to enter the cell.

The “door” the new coronavirus is entering through is known as the ACE-2 protein. Kruse's technique involves detaching the external portion of ACE-2, which would act as a decoy for the virus. The virus would bind to the decoy, leaving it unable to reach the actual door into the cell, and thus unable to cause infection.

“It won't realize, 'Oh gosh, this isn't a cell,'” Kruse explained in an interview. “The virus can't mutate away from this.”

Kruse's decoy therapy would not be available until fall at the earliest. A similar version of the strategy, however, is being tested now in trials in China.

Using a drug for a new purpose

A faster option involves what's called “repurposing” a drug.

This is when a drug that has already been found safe and approved for treatment of one disease also is found useful in treating another. One example is the drug Sildenafil, which is sold as Viagra and used to treat both erectile dysfunction and pulmonary hypertension.

There are three ways in which scientists try to find an existing drug that can treat a new condition.

The rational method involves using drugs that have characteristics and targets that suggest they might be used to treat the new condition.

The computational method involves examining protein structures and using them to predict an existing drug that might work.

The final method takes advantage of the vast drug libraries possessed by companies and academic institutions. High-speed technology allows researchers to screen thousands of drugs quickly to determine whether they will act against a specific target.

Considerable hope, interest and money have been invested in one drug not previously approved, remdesivir. The drug was tested against Ebola but failed in trials.

Gilead Sciences, a biopharmaceutical company based in Foster City, California, announced that two clinical studies of the drug are beginning this month. Two more clinical trials of the drug already have begun in China.

In the U.S., the clinical trials process is slow and painstaking, taking several years and sometimes much longer.

'The idea is right'

Another approach to the new virus championed by numerous researchers is the use of lab-made proteins called monoclonal antibodies.

These confer what's called “passive immunity” and have been used before to treat cancer, multiple sclerosis, cardiovascular disease and many other conditions.

 “The use of monoclonal antibodies is a new era in infectious disease prevention which overcomes many drawbacks associated with serum therapy … in terms of specificity, purity, low risk of blood-borne pathogen contamination and safety,” wrote the authors of a recent paper in the Asian Pacific Journal of Allergy and Immunology.

The biotechnology company Regeneron, based in Tarrytown, New York, started work searching for a monoclonal antibody “for this particular virus in early/mid-January,” said Christos Kyratsous, the company's vice president for infectious diseases and viral vector technologies. “But really we started working on it decades ago when we began building our unique end-to-end drug discovery and development technologies.”

Gregory Poland, director of Mayo Clinic's Vaccine Research Group, said the use of monoclonal antibodies “needs to be designed and tested in this specific disease, but I wouldn't see any reason it wouldn't work. The idea is right.”

other scientists, Poland was less hopeful that a vaccine would be developed anytime soon.

“We won't have a vaccine for this outbreak,” he said. “It will be before the next (outbreak).”

Monoclonal antibodies do have pitfalls. They require extensive testing. Also, viruses can mutate and escape from the antibodies. Companies sometimes target two different parts of the virus to make it harder for the virus to mutate and elude the antibodies.  

Ajay K. Sethi, associate professor of population health sciences at the University of Wisconsin-Madison, expressed support for the development of monoclonal antibodies.

“In my opinion, trying a strategy monoclonal antibodies to provide passive immunity is a good idea,” Sethi said. He added that given the technique's past successes, “it is hopeful, but not surprising.”

Strategies for combating the new coronavirus will ly require reaching patients early before they get too sick. Toward that end, Kruse said he believes the U.S. should pursue the much broader coronavirus testing policy that South Korea adopted. 

“Maybe in the next few weeks we will get to the point where we are testing everyone,” he said.

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Источник: https://www.usatoday.com/story/news/health/2020/03/15/coronavirus-treatment-could-coming-doctors-say-still-no-vaccine/5052788002/

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