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“This is a very important milestone,” Sahin told CNN in an exclusive interview. “I am very happy that we had such a good meeting and the FDA cleared the vaccine so that we can make our vaccine available to the American population.”

The FDA cleared the vaccine Friday night after its advisers recommended the go-ahead. the US it follows several other countries in licensing the vaccine, including the UK, which has already immunized at least 2,000 people.
Grace Thomson (left) receives the first of two injections of the Pfizer / BioNTech Covid-19 vaccine, administered by Paula McMahon, at the NHS Louisa Jordan Hospital in Glasgow, on the first day of the largest immunization program in UK history.  Nursing home workers, NHS staff and people over the age of 80 started taking the hit this morning.  PA Photo.  Image date: Tuesday, December 8, 2020. See PA SALUD Coronavirus story.  Photo credit should read: Jeff Mitchell / PA Wire
Grace Thomson (left) receives the first of two injections of the Pfizer / BioNTech Covid-19 vaccine, administered by Paula McMahon, at the NHS Louisa Jordan Hospital in Glasgow, on the first day of the largest immunization program in UK history. Nursing home workers, NHS staff and people over the age of 80 started taking the hit this morning. PA Photo. Image date: Tuesday, December 8, 2020. See PA SALUD Coronavirus story. Photo credit should read: Jeff Mitchell / PA Wire (AP)

The EUA was ultra-fast by US regulatory standards, especially for a vaccine using new technology.

BioNTech’s vaccine uses messenger RNA, genetic material that encodes a part of the virus’s spike protein, the outer hook that attaches itself to cells that the virus attacks. This mRNA causes the human body to produce small parts of the protein and then produce an immune response against it.

Clinical trials in more than 40,000 people showed that it was 95% effective in preventing symptomatic diseases.

“The most important finding is that we expect vaccinated people to have a much lower risk of hospitalization. That means we expect a lower risk of hospitalizations in the United States,” Sahin said.

“We will not have a direct impact on the spread of the pandemic in the next few months as, of course, we need to reach a large proportion of the population to slow down the outbreak.”

A vial of Pfizer / BioNTech COVID-19 vaccine ready for administration at Guy's Hospital at the start of the largest immunization program in UK history.
A vial of Pfizer / BioNTech COVID-19 vaccine ready for administration at Guy’s Hospital at the start of the largest immunization program in UK history. (Getty)

Pfizer has only been able to produce a few million doses for the United States so far, so it won’t immediately affect the pandemic, Sahin said. But after more people get vaccinated, the effects will kick in, he predicted.

“It could start depending on how quickly we can roll out and also depending on when other companies join us,” he said. “It could happen in early March, mid-March, late March to see the first effects. And I hope that with the spring season we naturally have a lower rate of infections. And the combination of both could help us have a better summer. than the current situation. “

US vaccine advisers speaking about the USA were concerned about reports of allergic reactions to the vaccine, at least two in Britain, as well as reports that around 9 percent of people who received The injections in clinical trials suffered reactions such as headache, fever, and muscle aches that lasted up to two days.

“Actually, this is something well known,” Sahin said.

“So it is known that people with a known anaphylactic reaction are at risk of being vaccinated with any type of vaccine. So this is not a big surprise and precautions should be taken. And one of the most important precautions is that the vaccination is carried out under the supervision of a doctor, “he added.

“So if severe reactions occur, the doctor can react, they can provide, for example, corticosteroids. And this happened exactly in the UK. The two participants recovered after receiving corticosteroids and treatment, treatment with adrenaline. And most importantly it is understanding the risk profile of the individual subject and then deciding on a case-by-case basis whether or not the vaccine should be applied. “

Pfizer vaccine vials
Pfizer vaccine vials (Pfizer)

Sahin said he was confident that BioNTech and Pfizer had chosen the safest candidate vaccine from a lot of possibilities.

“The safety data shows that this is a vaccine like any other antiviral vaccine with a benign safety profile, mild and moderate side effects. Typical side effects are injection site pain, fever, and headache in a proportion of participants. About the study we can say that this is a safe and highly effective vaccine, “he said.

Some people have also been concerned that because the vaccine uses messenger RNA, it could somehow permanently affect a person’s genetic makeup.

“This will not happen; the mRNA does not interfere with or change the DNA,” Sahin said. “This is a well-known problem. It is a molecule that is transient. It is in most cells only in the cytoplasm and it degrades rapidly. Therefore, this is not a justified fear.”

One question that has yet to be answered is how long the vaccine can protect people.

“This is important. The duration of immunity depends on two things: one is the vaccine itself, but on the other hand also the virus,” Sahin said.

“We know that the virus tends to be more likely to be reinfected in people who have not generated antibodies. And we also know that the antibody status required to neutralize this virus is relatively high. That means we have to see how long the antibody response lasts. that is generated by our (hard) vaccine – and we know the antibody titers are high, but now we have to monitor those three months, six months, nine months, 12 months. We have three-month data showing that the titer of antibodies is relatively stable but we will continue to monitor this. “

There are also doubts about the production of vaccines. Pfizer expected to have hundreds of millions of doses produced now, but it has far fewer.

“We have planned to produce up to 1.3 billion doses in 2021,” Sahin said.

‘V Day’: Scenes of triumph as UK starts COVID-19 vaccination program

“And now, realizing that more doses might be necessary, we began a few weeks ago to assess whether we can produce more doses. And this, of course, means that we must understand the limitations.

“For example, the availability of raw materials, the availability of machines, production rooms and filling and finishing capacity. And this is exactly happening. And I anticipate that by the end of January we will be able to clearly indicate if we can produce more doses and, if so, how many more doses “.

Sahin said the demand is there.

“This is necessary. We anticipate that the need, the global need for our vaccine, is much greater than we initially estimated, as some of the vaccines that were planned for 2021 will arrive later,” he said.


www.9news.com.au

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