Tag: Moderna

Categories
Health

FDA says it hasn’t authorized Moderna Covid vaccine regardless of Trump tweet

FDA says it hasn't approved Moderna Covid vaccine despite Trump tweet

US President Donald Trump gives a speech at an Operation Warp Speed ​​Vaccine Summit on December 8, 2020 at the White House in Washington, USA.

Tom Brenner | Reuters

The Food and Drug Administration has not yet approved Moderna’s coronavirus vaccine, contrary to a tweet from President Donald Trump on Friday that said the agency had “overwhelmingly approved” it and would distribute it immediately.

The FDA did not comment on Trump’s tweet, instead referring CNBC to a statement from FDA Commissioner Dr. Stephen Hahn said Thursday evening that the agency would “work quickly towards finalizing and issuing emergency clearance” for Moderna’s vaccine.

“The agency has also notified the US Centers for Disease Control, Prevention and Operation Warp Speed ​​so that they can implement their plans for a timely distribution of the vaccine,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.

The FDA statement on Thursday “is current,” FDA spokesman Michael Felberbaum told CNBC after Trump’s tweet.

It’s possible that Trump was referring to a vote by the FDA’s Advisory Committee on Vaccines and Related Biological Products Thursday, which voted 20-0, with one member abstaining to approve Moderna’s emergency vaccine advocate. The advisory board plays a key role in approving influenza and other vaccines in the US and verifying that the vaccinations are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

The FDA is expected to approve Moderna’s vaccine as early as Friday. The US plans to ship close to 6 million cans next week pending agency approval. This was announced by General Gustave Perna, who oversees the logistics for the Operation Warp Speed ​​vaccination project, to reporters on Monday.

Categories
Health

Moderna Covid vaccine FDA accepted for emergency use

Moderna Covid vaccine FDA approved for emergency use

The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine – the second to be approved for use in the US after Pfizer and BioNTech – strengthens the US dose supply. The potentially life-saving shots are badly needed to fight the pandemic that left more than 300,000 Americans dead and hospitals overwhelmed.

With the FDA’s approval for the emergency on Friday, the federal government’s plan to distribute approximately 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the country next week will be approved.

“We’ll probably see gunshots in the arm early next week, I hope Monday or Tuesday,” said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, on the “Today” show on Friday morning.

President Donald Trump said in a tweet: “Congratulations, the Moderna vaccine is now available!”

In addition to Moderna’s vaccine, the U.S. is planning to ship 2 million doses of Pfizer’s vaccine after 2.9 million doses were cleared for shipping this week, General Gustave Perna, who oversees logistics for the Operation Warp Speed ​​vaccination project, said Monday . Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is the first product to be approved by the FDA.

“With the availability of two vaccines to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic, which causes large numbers of hospitalizations and deaths in the US every day,” said FDA Commissioner Dr. Stephen Hahn said in a statement.

US officials hope to vaccinate at least 20 million Americans by the end of the year – mostly healthcare frontline workers and nursing home residents. The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has given states an overview recommending that health workers and nursing homes be prioritized. However, states may distribute the vaccine at their own discretion.

States are already reporting confusion about vaccination plans. In the past few days, state officials said they learned that their second shipment of Pfizer’s vaccine would be smaller than expected or delayed. In Florida, for example, Republican Governor Ron DeSantis said the federal government had told him the state would receive 205,000 Pfizer vaccine doses next week and 247,000 the following week. Those shipments are now on hold, DeSantis said at a press conference Tuesday, and it is unclear when they will arrive.

Moderna’s vaccine, like Pfizer’s, uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data released last month shows that Moderna Covid’s vaccine is more than 94% effective at preventing, safe and appearing to fight off serious diseases. For maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved Moderna’s vaccine for people aged 18 and over. Such authorization by the agency is not the same as a full authorization, which requires more data and can usually take several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval and can revoke an EEA for a drug at any time if it doesn’t work as intended or if it proves unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no evidence of benefit” in coronavirus patients.

The FDA announcement comes after a key agency advisory body voted 20-0 with one abstention on Thursday to recommend the emergency vaccine. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

Prior to the vote, some committee members stressed their approval of Moderna’s vaccine was not in favor of full FDA approval, and reiterated that the agency needed to review more data on safety and efficacy.

During the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health workers who were taking Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency is looking into the problem.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “Right now we don’t have enough data to make a definitive recommendation one way or another.”

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.

The FDA said while this isn’t necessarily a side effect, it does recommend monitoring people who receive Pfizer’s or Moderna’s vaccine shots for possible cases of Bell’s palsy, a condition that causes sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.

According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week it would buy another 100 million doses of Moderna’s vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower “pandemic prices” this month. The company said it was under discussion for larger volume agreements that will have a lower price.

– CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.

Categories
Health

Moderna Covid vaccine unwanted effects: Fatigue, complications, muscle ache

Moderna Covid vaccine side effects: Fatigue, headaches, muscle pain

Tony Potts, a 69-year-old retiree who lives in Ormond Beach, will receive his first injection as a participant in a Moderna-sponsored Phase 3 COVID-19 clinical vaccine trial on August 4, 2020 at Accel Research Sites in DeLand, Florida.

Paul Hennessy | NurPhoto | Getty Images

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s Covid-19 vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling that are likely caused by the gunfire. That is based on new data released Tuesday by Food and Drug Administration.

On the positive side, people over 64, who are also among the most severely affected by the disease, were generally better tolerated than younger people.

Vaccine side effects are common. It’s actually an immune response that indicates the shots are working as intended, doctors say. Many doctors advise the public to prepare for some more severe side effects than usual with the Covid-19 injections than, say, a typical flu shot, and possibly to take a day or two off to recover.

Moderna’s vaccine, which was approved by FDA officials on Tuesday, is more than 94% effective and safe enough to meet agency requirements for an emergency, according to the report. However, the regulator’s analysis found that the vaccine was associated with common and unpleasant, but not necessarily dangerous, side effects.

More than 9 out of 10 participants who received the vaccine felt pain at the injection site, nearly 7 out of 10 felt tired, and about 6 out of 10 had a headache or muscle pain, the FDA said.

More than 44% of people who received the vaccine reported having joint pain and over 43% reported having chills. The FDA found that more serious “serious side effects” occurred in 0.2% to 9.7% of participants, “occurring more often after the second dose than after the first. Like Pfizer’s Covid vaccine that the FDA approved last week, Moderna’s vaccine also requires two shots, separated by a few weeks.

According to the FDA, nearly 15% of vaccine participants had a fever after the first or second dose.

Some side effects were tough to shake, although most were resolved within a week, the FDA said. Less than 6% reported symptoms that lasted for at least a week after the shot, but that were similar to the placebo group. Some of the study participants had a fever that lasted for more than a week. Seven were in the vaccine group and four were given the placebo, the FDA found.

The FDA said there were seven “serious adverse events” in the study, but none of them were fatal. Four were attributed to the vaccine by investigators and Moderna, including persistent nausea and vomiting, facial swelling, and rheumatoid arthritis.

The FDA staff also recommended that people receiving the vaccine be monitored for possible cases of Bell’s palsy. This isn’t necessarily a side effect, but it’s worth looking out for now that four of the 30,000 participants in the study contract this condition, which causes half of your face to fall off.

Categories
Health

Moderna Vaccine Is Extremely Protecting and Prevents Extreme Covid, Knowledge Present

Moderna Vaccine Is Highly Protective and Prevents Severe Covid, Data Show

WASHINGTON – Newly released data confirmed on Tuesday that Moderna’s coronavirus vaccine offers high levels of protection and sets the stage for this week’s emergency approval from federal regulators and beginning its spread across the country.

The Food and Drug Administration intends to approve use of the vaccine on Friday, said people familiar with the agency’s plans. The decision would give millions of Americans access to a second coronavirus vaccine as early as Monday.

The FDA review confirms Moderna’s earlier assessment that the vaccine had an efficacy rate of 94.1 percent in a study of 30,000 people. Side effects, including fever, headache, and fatigue, were uncomfortable but not dangerous, the agency found.

The success of Moderna’s vaccine has become all the more important to fighting the pandemic as other vaccine efforts have stalled. The hopeful news comes at a time with a record number of coronavirus cases overwhelming hospitals and an ever-increasing death toll that hit a bleak milestone of 300,000 on Monday.

The data release is the first step in a public review process that includes a one-day meeting on Thursday by an independent panel of experts. You will hear from Moderna, FDA scientists, and the public before they vote on whether to recommend approval. The panel is expected to vote yes and the FDA generally follows the experts’ recommendations.

Distribution of about six million doses could then begin next week, significantly adding to the millions of doses already developed by Pfizer and BioNTech, the companies that only released the first emergency coronavirus vaccine last Friday . Healthcare workers received the first shots of the Pfizer BioNTech vaccine Monday with an efficacy rate of 95 percent.

The introduction of vaccines has been eagerly anticipated and is one of the most ambitious vaccination campaigns ever carried out in the United States.

Last summer, the federal government signed contracts with Moderna and Pfizer to dispense a total of 200 million cans in the first quarter of 2021. Since both vaccines require two doses, these contracts guaranteed enough doses for 100 million people.

Last week the government announced that it had bought an additional 100 million doses of Moderna for the second quarter, bringing the number of Americans who can be vaccinated to 150 million. That leaves the question of how and when the 180 million or so other Americans will be covered.

Both vaccines are made available to the public free of charge.

Moderna’s vaccine has become a symbol of government scientists’ successes during the pandemic. After China released the genetic sequence of the new virus in early January, scientists from Moderna and the National Institutes of Health were able to focus on designing a vaccine in just two days. Unlike Pfizer, Moderna has a close relationship with Operation Warp Speed, the federal program that seeks to get a vaccine to market quickly. Nearly $ 2.5 billion federal funding helped Moderna buy raw materials, expand its factory, and increase its workforce by 50 percent.

Moderna’s success contrasts with two other high profile projects the US had hoped would increase vaccine supply: one from pharmaceutical companies Sanofi from France and GlaxoSmithKline from the UK and one from Anglo-Swedish drug maker AstraZeneca and the Oxford University.

AstraZeneca and Oxford used two different doses in clinical trials in the UK and Brazil. The effectiveness was 62 percent at one level and 90 percent at the other. These jumbled results have made it unclear when AstraZeneca will have enough data to obtain an emergency clearance.

Meanwhile, Sanofi and GlaxoSmithKline received disappointing results with their vaccine in early clinical trials. While it produced a promising immune response in volunteers under the age of 50, it did not do so in older people. The companies are now planning a series of new studies with a different version of the vaccine. Due to the delay, they are unlikely to provide vaccines before the end of 2021.

Moderna’s vaccine worked equally well in white volunteers and in color communities. There was also no significant difference between protecting men and women or between healthy volunteers and those at risk for severe Covid-19 who developed conditions such as obesity and diabetes. For people aged 65 and over, the study found an estimated effectiveness of 86.4 percent, which is below the overall estimate of 94.1 percent. However, the apparent difference was not statistically significant.

So far, FDA reviews have shown two possible differences between vaccines, but the results may reflect a lack of data more than real differences. The Pfizer BioNTech study showed that the vaccine began protecting against the coronavirus within about 10 days of the first dose. The experiment with the vaccine from Moderna, however, did not show such a noticeable effect after the first dose.

However, in the early days of the Moderna study, there were fewer cases of Covid-19 among study participants, making it more difficult to measure the differences between the vaccinated group and the placebo group. In either case, health officials have said that for both vaccines, two doses are essential for complete protection.

Updated

Dec. 15, 2020 at 9:31 am ET

A second difference concerns the ability to prevent serious diseases. Moderna presented more evidence that its vaccine can, according to the review. In his study, 30 volunteers developed severe cases of Covid. All of them belonged to the placebo group, with no cases among the vaccinated people.

In the Pfizer BioNTech study, the results were less convincing. There were 10 severe cases in the placebo group and one in the vaccinated group. These numbers are too few to assess the vaccine’s ability to prevent serious diseases.

“The data available for these results did not allow firm conclusions,” said the FDA.

The documents released on Tuesday made it clear that side effects were particularly common after the second dose, but usually lasted only one day. Experts say people may need to take a day off after the shot.

During the Moderna trial, researchers also kept an eye out for volunteers who developed new disorders. In a multi-month study of 30,000 volunteers, it is normal for some to have conditions unrelated to the vaccine, health experts say. Comparing the rates between people receiving the vaccine and placebo, as well as general background rates, can help identify serious concerns and eliminate coincidences.

During the Moderna study, three vaccinated participants developed a form of temporary facial paralysis called Bell’s palsy, while one participant on the placebo experienced the same. Bell’s palsy, which can last weeks or longer, can be triggered by viral infections and other causes. Around 40,000 people develop the disease in the United States each year. Years of intensive research have found no evidence that any vaccine routinely recommended in the US causes Bell’s palsy.

In the review released Tuesday, the FDA said, “There is insufficient information currently available to establish a causal relationship with the vaccine.”

The Pfizer BioNTech study identified four cases in the vaccine group, including one in a person with a history of the disorder and none in the placebo group.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said in an interview with JAMA Monday that the cases of Bell’s palsy in the study were most likely not caused by the vaccine and that the apparent difference between the two groups of volunteers was only one reason Random question.

“Our working hypothesis is just that this is an imbalance in the background rates, as we’ve seen in other studies,” he said.

In its analysis of the Moderna vaccine released Tuesday, the FDA said it plans to recommend prosecuting Bell palsy cases when the vaccines are rolled out.

“We’re going to ask about this just to wrap up that question,” said Dr. Marks on Monday.

The FDA’s analysis did not reveal any serious allergic reactions to the Moderna vaccine. The same was true for the Pfizer-BioNTech clinical trial, but when vaccinations began in the UK outside of that study, two people with a history of serious allergies had a severe and potentially life-threatening reaction called anaphylaxis.

UK health officials have said people with a history of anaphylaxis should avoid the Pfizer BioNTech vaccine.

In the United States, the Centers for Disease Control and Prevention has stated that people with serious allergies can be safely vaccinated, with close monitoring for 30 minutes after receiving the shot.

Moderna and Pfizer-BioNTech vaccines are similar in their ingredients, but not identical. Therefore, it is not clear whether an allergic reaction to one vaccine would occur with the other. Both are made up of genetic material called mRNA that is enclosed in a bladder made of a mixture of fats. The two companies use different fats.

Moderna has applied for approval to vaccinate people aged 18 and over, as in its study. The Pfizer BioNTech vaccine was approved for people aged 16 and over because the study included a number of younger volunteers. Both companies are conducting experiments with children aged 12 and over and plan to also study younger children.

Sharon LaFraniere contributed to the coverage.

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]