[ad_1]
Pfizer said its vaccine candidate was over 90% effective in preventing infection in volunteers. It uses a never-approved technology called messenger RNA, or mRNA, to produce an immune response in people who are vaccinated.
“It shows that the mRNA platform actually works. And there is another vaccine candidate, Moderna, which uses the same platform,” Fauci told CNN in a telephone interview.
The Fauci National Institute of Allergy and Infectious Diseases is working with Moderna and other companies to test their experimental vaccines.
The US federal government has invested $ 1.95 billion in vaccines from Pfizer and BioNTech, but is not working directly to help its development.
The mRNA vaccine approach uses genetic material called mRNA to trick cells into producing pieces of protein that look like pieces of the virus. The immune system learns to recognize and attack these elements and, in theory, would respond quickly to any real infection.
“Really encouraged to see this exciting announcement. Assuming it’s backed by data, this not only represents a potential breakthrough for Pfizer / BioNTech, but also for vaccines in general,” vaccine expert Robin Shattock, whose the team at Imperial College London is working on a coronavirus mRNA vaccine, said in a statement.
“It also demonstrates the speed and utility of RNA vaccine technology,” added Shattock.
“This announcement certainly gives a boost to our own self-amplifying RNA vaccine program. Not the end of the game yet, but we hope for the start of global efforts to control this pandemic. Significant light at the end of the tunnel.”
There is a second reason why Pfizer’s results are good news for other vaccines. They show that using spike proteins as a target was the right decision, Fauci said.
“The other good thing about it is that an actual immune response to the spike protein is a protective response,” Fauci said.
The virus has a structure called a spike protein to attack the cells it attacks. MRNA vaccines allow the body to make small copies of this structure.
“Remember – people weren’t sure if you made an immune response against the spike protein, that would be the best and most suitable target for an actual vaccine,” Fauci added.
Target the peak
“The good news is that this is the target of the spike protein and virtually every other vaccine tested also uses the spike protein as a target, whether expressed in mRNA or ‘a soluble protein. The spike protein is used in all, which bodes well for all other vaccines. “
Four coronavirus vaccines are in advanced phase 3 trials in the United States. They are manufactured by Pfizer, as well as Moderna, Johnson & Johnson and AstraZeneca. Additionally, Maryland-based Novavax is expected to start a Phase 3 trial in the United States later this month. A trial is underway in Great Britain.
Pfizer has had such a quick indication that its coronavirus vaccine is highly protective against infections in part because the pandemic is so severe, Fauci said.
The data was revealed as part of what is called an interim analysis. These are pre-planned previews of the data.
In this case, Pfizer had planned to take a look as soon as 62 people in its trial of 44,000 volunteers developed Covid-19 infections. But before the company could even finish discussing its plans with the United States Food and Drug Administration, 94 people had been infected within a week of their second dose of vaccine or placebo.
Pfizer’s Data and Safety Monitoring Board – an external team of experts who view the trial with a neutral eye – unveiled the data and found that more than 90% of those cases were in people who received a placebo or injections. dummy.
This reflects both the large size of Pfizer’s trial and the infection rate in the United States, which has just passed its 10 millionth diagnosed case, Fauci said.
“An answer depends on the size of the trial and the number of infections in the community,” he said. It is not clear whether all of the cases Pfizer used for its interim analysis were in the United States. The company is also testing the vaccine in Brazil, South Africa, Japan and other countries.
“It was an essay that was aimed at 44,000 people and we are currently in the midst of a big increase. These two things together make it much more likely that you will get a response quickly, which has happened – we got a quick response, ”Fauci added.
Fauci said he expects Pfizer to apply to the FDA for emergency use clearance in about a week and a half. It will be two months since the volunteers received their second dose of vaccine. The FDA has asked vaccine makers for two months of safety data before seeking approval.
[ad_2]
Source link