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Home / Business / Pfizer successfully declared coronavirus vaccine, emergency plan OK

Pfizer successfully declared coronavirus vaccine, emergency plan OK



  • On Monday, the drugmaker said Pfizer’s experimental coronavirus vaccine had been successful in the final stage of the clinical trial, a key milestone in society’s fight against the pandemic.
  • Developing an effective vaccine against a brand new virus in less than a year is an unprecedented feat in the history of medicine.
  • Research shows that people who get Pfizer are less likely to get COVID-19, a disease caused by the new coronavirus. The drug was found to be more than 90% effective in blocking COVID-19, the manufacturer of the drug said.
  • Pfizer described the results in a press release. The trial is still ongoing and the results have not been released temporarily in a peer-reviewed medical journal.
  • The vaccine will not be available to everyone right away. It still needs to be evaluated by the Food and Drug Administration.
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A top coronavirus vaccine candidate has been working to stop people from developing COVID-19, a key milestone in society’s fight against the pandemic.

Pharmaceutical company Pfizer said on Monday that its vaccine was successful in the final stages of a clinical trial, comparing tens of thousands of volunteers who received two experimental doses of the vaccine with a group taking salt water placebo.

The drug’s manufacturer says the drug was found to be 90% more effective in preventing COVID-19, based on 94 cases of the disease observed in the study.

Next, the New York drug giant plans to apply for an emergency license to allow for wider distribution of the footage. The company still needs more data on the safety of the vaccines before asking for an urgent OK and said it won’t have the information it needs until later this month.

Pfizer and German partner BioNTech were the first to report positive results from a key trial of the COVID-19 vaccine. Developing and testing an effective vaccine in less than a year is an unprecedented achievement in medicine. Shares in Pfizer and BioNTech soared in pre-open trading on Monday morning. The broad market rose on Monday, celebrating the vaccine’s success as a key part of dealing with the pandemic.

While the study is still underway and will collect further safety and efficacy data, the key conclusion from an interim analysis is that the vaccine is effective.

“Today is a great day for science and humanity,” Pfizer CEO Albert Bourla said in a statement. “The first set of results from our Phase 3 COVID-19 vaccine trial provides preliminary evidence of the vaccine’s ability to prevent COVID-19.”

However, questions remain, such as how long does vaccines work and whether any extremely rare but serious side effects have yet to be discovered.

The impact of success will not be immediate. The main challenges are now shifting from science to management, logistics and politics. Regulators must review the data and decide if there is enough evidence to approve the footage. Supply will also be very limited for the first few months, due to increased production.

Pfizer’s vaccine will also pose unusual logistical challenges. It needs to be transported and stored at -94 degrees Fahrenheit. The Center for Disease Control and Prevention estimates the U.S. will have a supply of about 20 to 30 million doses of the Pfizer vaccine by 2020, i.e. enough dose to vaccinate less than 10% of the US population.

If the vaccine is approved urgently, it will not be available to everyone at the same time. The first people to be vaccinated may be at high risk of illness, such as frontline health workers and the elderly.

Even when people started vaccinating, experts stressed that it was essential to wear a mask and stay away from society.

While the study has been successful with its primary goal of reducing cases of symptomatic COVID-19, it may not necessarily mean that the shot prevents infection without symptoms or serious illness. .

That means vaccinated people can still be carriers of the unknown virus and could still face a serious risk of developing COVID-19, requiring hospitalization and possibly even leading to dead. Long-term data from the study can help answer these questions.

Read more: There are 176 coronavirus vaccines under study. Here’s how the top drugmakers see the race to find a cure in 2020 and 2021, and when the first injections are possible.

Initial results are limited, but Pfizer shows strong results

These results come from an interim analysis of the study, which is still ongoing. Testing will continue through the final analysis of 164 cases of COVID-19, which should help deliver stricter results over time.

The trial recruited 43,538 volunteers, randomized with either a vaccine or a placebo. Researchers designed the study to count COVID-19 cases among trial participants. When certain volunteers fell ill, an independent panel of experts looked at the data to see whether people who received the experimental vaccine were less likely to get sick than those taking a saltwater placebo. are not.

The primary goal is to see if the vaccine reduces cases of COVID-19 after both doses are given. The testing protocol appoints a COVID-19 as a person who tests both positive and symptomatic. The researchers counted cases starting one week after volunteers received a second dose. Pfizer said on Monday that protection from the virus will be reached 28 days after the initial dose.

There are no long-term follow-up data available for people receiving the Pfizer vaccine. That means the important questions about the durability of the shot protection measure as well as the risk of any long-term side effects remain unknown.

Research will continue to address those questions. Experts note that vaccine trials can rarely identify extremely rare side effects, possibly one in a million events. US health agencies have surveillance systems in place to monitor a vaccine’s effectiveness and safety after a shot is released to the public.

Read more: 5 experts show how they determine whether coronavirus vaccine is really safe and effective – here’s what you need to know to evaluate data for yourself

vaccine against corona virus

A researcher is working on a new coronavirus vaccine, COVID-19.

THIBAULT SAVARY / AFP via Getty Images



Pfizer is preparing for a quick approval

Through the Warp Speed ​​Campaign coronavirus vaccine initiative, the US government has been preparing for the clinic’s success for months.

The US government reached an agreement in July with Pfizer to buy 100 million doses of the drug for $ 1.95 billion. That contract also includes the option to purchase an additional 500 million doses. Pfizer has reached agreements with dozens of governments around the world, outside of the United States, that allocate portions of the initial supply to many countries.

Read more: Trump’s coronavirus vaccine king told us how Operation Warp Speed ​​decides which 6 candidates will return with massive multibillion-dollar deals

In total, Pfizer is expected to produce 50 million doses by the end of 2020 and up to 1.3 billion doses by 2021.

The US Food and Drug Administration will decide whether to license the experimental vaccine. The agency is expected to promptly convene an independent panel of experts to review the data after Pfizer has submitted an application. While Pfizer said it will have enough safety data from the study in the third week of November to submit the vaccine for review, it’s unclear how quickly the regulatory process will proceed from there.

The FDA’s panel of experts typically has a long public meeting to question the rigor of the data, the risks, and benefits of approving an experimental drug. FDA scientists will then review the group’s recommendations and finally make a decision to approve.

Usually, it takes six to 10 months for the agency to review new drug and vaccine applications. While it is widely expected that timeline will be significantly accelerated due to the urgency of a pandemic, the exact timetable remains unclear.

Vaccine

In the profile photo Wednesday, June 24, 2020, a volunteer is injected at Chris Hani Baragwanath Hospital in Soweto, Johannesburg.

Siphiwe Sibeko / Pool via AP


More results are expected in the coming months for the rival COVID-19 vaccine

While Pfizer’s vaccine was the first to report successful end-stage testing results, several other drug developers are aiming to quickly track results for their own vaccines.

Other pioneers are biotech company Massachusetts Moderna, British pharmaceutical giant AstraZeneca and University of Oxford, the world’s largest healthcare company Johnson & Johnson, and biotechnology company. Maryland Novavax Small School.

The vaccines developed by all drug manufacturers have begun the final phase of clinical trials. Moderna is expected to report results in November, while AstraZeneca is aiming to have data available by the end of the year. J&J and Novavax are likely to have results a little later, aiming for late 2020 or early 2021.

Pfizer’s success is expected to spur confidence in other vaccines, as all of these injections target the same part of the coronavirus: its mutant protein. It also confirms promising technology in vaccine research that has yet to be proven. Pfizer’s candidate is an informational RNA vaccine (mRNA), which requires only the genetic code of the virus to create an experimental vaccine.

Pfizer’s reading is the first success in a study that focused on the effectiveness of the technology to work in humans. Moderna also specializes in the treatment of mRNA and vaccines, and was the first drug manufacturer in the world to start testing the human COVID-19 vaccine in March.

Read more: The Untold Story of Moderna when biotech’s coronavirus vaccine faces an experiment that could make it one of the most repercussive startups of all time

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