In July, Pfizer and BioNTech launched a late clinical trial of the coronavirus vaccine. Half of the people got the vaccine and the other half got the saltwater placebo. The companies then waited until people got sick to see if the vaccine offered protection.
So far 94 of the almost 44,000 participants have signed a contract with Covid-19. The independent panel of experts examined how many of these people had received the vaccine and how many had received the placebo. This first analysis shows that the vaccine is more than 90% effective.
As usual in clinical studies, data were collected blindly, meaning that no one knows how many of the 94 people infected with the virus received the vaccine or placebo, except an independent group – not the volunteers, the doctors or the management. However, as the vaccine is more than 90% effective, it can be assumed that only a few vaccinated people have received Covid-19.
That’s right. The Food and Drug Administration has set a 50% efficacy limit for vaccine manufacturers wishing to submit candidates for urgent approval. If the preliminary results from Pfizer and BioNTech confirm this – and accurately reflect how the vaccine will work in the real world – then it’s much safer.
To understand how good these results are, it is useful to think about the approved vaccines that people get regularly. In small quantities, flu vaccines are at best 40-60% effective, as the flu virus develops new forms year after year. In contrast, two doses of measles vaccine are 97% effective.
A patient received one dose in May during a vaccine study conducted by Pfizer at the University of Maryland School of Medicine. University of Maryland School of Medicine lending through Associated Press.
To date, Pfizer and BioNTech have not reported any serious safety issues with their vaccine. Prior to the current large-scale study, companies had been conducting small clinical trials since May specifically designed to identify early warning signals for the safety of the vaccine. They tested four versions of the vaccine and selected the vaccine with the least mild and moderate side effects such as fever and fatigue.
When their vaccine has been approved by the F.D.A. for emergency use and is distributed to millions of people, the Centers for Disease Control and the F.D.A. will keep an eye on them to ensure that there is no evidence that there are even fewer safety issues.
The participants in the study are also followed for two years.
The first to ask for a new vaccine would be primary care workers. The loan… Taylor Glasscock for the New York Times…
Pfizer’s CEO said 30 to 40 million doses of the vaccine could be available by the end of the year, enough for 15 to 20 million people to receive the first vaccination and the booster three weeks later.
The question of who can receive the first doses has not yet been answered, but groups with a higher risk of infection or who are more susceptible to the virus are likely to receive priority treatment. These could be healthcare workers, the elderly and people with risk factors such as obesity or diabetes.
Pfizer and BioNTech say they can increase doses up to 1.3 billion a year. This is still not enough to meet the global demand for vaccines. If other vaccines are also effective, companies can produce them and help meet demand.
Pfizer said it is likely to seek emergency approval in the third week of November, after two months of collecting the safety data that the FDA has requested from manufacturers. The Agency will then consult an external advisory committee of experts and it may take several weeks to assess detailed data on the safety, efficacy and ability of companies to safely produce millions of doses of vaccine.
The vaccine can be approved until the end of the year for certain risk populations, but this will only happen if everything goes according to plan and there are no unexpected delays.
The headquarters of BioNTech in Mainz, Germany. Pfizer and BioNTech say they can produce 1.3 billion doses of vaccine a year, although that’s still too little for global demand…Credit…Ralph Orlowski/Reuters.
The process continues until 164 Covida-19 files are completed. In this phase, the research is completed and the results are analysed.
Although the preliminary results are strong evidence of the vaccine’s effectiveness, they do not tell us with certainty how effective it is. Clinical trials are simply not equipped for this. They can enable scientists to make a statistically sound assessment – an assessment known as efficacy. The effectiveness of a vaccine can only be determined with certainty if millions of people get it. But experts say that the early evidence suggests that the efficacy must be very high.
The new results also do not tell us whether the elderly will be strongly protected by the vaccine. Pfizer and BioNTech clinical trials involve people over the age of 65, so they will ultimately provide this important information. Early clinical studies have shown that elderly people have a weaker immune response to coronavirus vaccines. But with such strong preliminary evidence, they can still get strong protection from the vaccine.
Another open question is whether children are protected by the vaccine. Pfizer and BioNTech’s studies were initially open to people aged 18 and older, but in September they began to include young people aged 16 and older. Last month they started a new trial with 12-year-olds and are planning to work at a younger age.
Dr. Francis Collins with a coronavirus model at a warp surgery hearing in Washington, D.C., in July. The loan… A picture of the pool, taken by Sol Loeb.
Vice President Mike Pence said on Monday on Twitter that the news came from a public-private partnership forged by Mr. Trump.
In July, Pfizer signed a $1.95 billion contract as part of the government’s Deformation Rate Surgery, an interagency initiative to urgently launch a 100 million-dose vaccine. The agreement is an initial purchase agreement, which means that the company will not be paid until it delivers the vaccine. Pfizer, unlike the major global manufacturers Moderna and AstraZeneca, has not received federal funding for the development or production of vaccines.
Pfizer was informed by Mr Trump and Operation Warp Speed. In an interview on Sunday, Catherine Jansen, senior vice president and head of vaccine research and development at Pfizer, said we were never part of Warp Speed, she added. We never took money from the U.S. government or anyone else.
On Monday, Pfizer’s spokesperson announced that the company, as a supplier of a possible coronavirus vaccine, is undertaking a deformity exercise.
While it is true that Pfizer and BioNTech worked on the vaccine all year before the companies signed the agreement with the U.S. government in July, the $1.95 billion agreement is still a major incentive to continue. After all, international health organizations have been using such AMCs for a long time to convince profitable manufacturers to supply vaccines to developing countries.
Ten other vaccines are currently in the final stages of testing around the world. The fact that Pfizer and BioNTech have achieved encouraging results makes the experts across the field optimistic.
This gives us more hope that other vaccines will be effective, said Akiko Iwasaki of Yale University.
Pfizer and BioNTech are testing a vaccine that uses a genetic molecule called RNA to force our own cells to produce a viral protein. Our immune system collides with the protein, forming antibodies and immune cells that can quickly recognise the protein and launch a rapid attack. Upgrading is currently at an advanced stage of testing with our own RNA vaccine, while the first clinical trials with other RNA vaccines are underway in China, England, India, Singapore, South Korea and Thailand.
But news from Pfizer and BioNTech can also be a source of inspiration for other vaccine developers. The vaccine from Pfizer and BioNTech forces our body to produce a viral protein called Spike. A number of other vaccines deliver the advanced protein, or just a fragment of it, to the immune system for recognition. Other vaccines are based on other viruses that introduce the gene for the advanced protein harmlessly into the cells. Although the advanced protein provides strong protection against coronaviruses, all these vaccines could also show encouraging results in the coming months.
The widespread success of coronavirus vaccines would be a huge benefit to global health as Pfizer and BioNTech alone cannot meet the entire demand.
Please don’t. The coronavirus rages throughout the country and public health experts say Americans must prepare for a very harsh winter.
Even if the vaccine is approved in a few months’ time, it will initially only be available to part of the American public. Most health authorities believe that an effective vaccine will only be available next year. However, there is still no data on whether the vaccine will stop the asymptomatic spread of the virus or to what extent it will prevent people from developing severe covid-19.
Most experts say that even when a vaccine is widely available, additional measures such as masks are needed until the public health threat disappears.
It doesn’t replace hygiene measures, but complements them, said Dr. Paul Ofit, professor at the University of Pennsylvania and member of the F.D.A. Vaccine Advisory Group. You have to do this for others to make sure you’re wearing a mask.