[Altavia]

Pfizer’s Covid-19 Vaccine Proves 90% Effective in Latest Trials - WSJ

Pfizer’s Covid-19 Vaccine Proves 90% Effective in Latest Trials

U.S. drugmaker and partner BioNTech could ask FDA to permit wide use of vaccine for the new coronavirus by end of November

A vaccine developed by Pfizer Inc. PFE 0.03% and partner BioNTech SE proved better than expected at protecting people from Covid-19 in a pivotal study, a milestone in the hunt for shots that can stop the global pandemic.

The vaccine proved to be more than 90% effective in the first 94 subjects who were infected by the new coronavirus and developed at least one symptom, the companies said Monday.

The positive, though incomplete, results bring the vaccine a big step closer to getting cleared for widespread use.

Pfizer said it is on track to ask health regulators for permission to sell the shot before the end of this month, if pending data indicate the vaccine is safe.

The timetable suggests the vaccine could go into distribution this month or next, though U.S. health regulators have indicated they will take some time to conduct their review.

“Hopefully now we can move on and get this vaccine out there and make sure it’s doing what it’s supposed to do and stop” the virus, said Kathrin Jansen, Pfizer’s head of vaccine research and development, in an interview.

The findings came too early for researchers to assess the safety of the vaccine, which the U.S. Food and Drug Administration says must include two months of monitoring at least half the study’s subjects for side effects.

Pfizer said it remains on track to collect at least two months of safety data during the third week of November and could file for an emergency authorization shortly thereafter.

So far, no serious safety issues have arisen in the study, the companies said. The study has enrolled nearly 44,000 subjects in the U.S. and other countries.

It is unclear how long the protection the vaccine appears to provide lasts, since researchers haven’t been studying volunteers for very long.

The interim review of the vaccine’s effectiveness and safety was performed by an outside panel of independent experts known as a data-safety monitoring committee, which then shared its findings with Pfizer and BioNTech.

You never know what the outcome is, but we had a feeling that we did everything we could possibly do,” Dr. Jansen said.

The vaccine is among the most-advanced in development in the West, with others in late-stage testing from Moderna Inc., Johnson & Johnson and AstraZeneca PLC.

Covid-19 vaccines developed by researchers in China and Russia have already been given to people in those and certain other countries.

Pfizer and BioNTech’s vaccine uses a new and unproven technology, known as mRNA, short for the molecular couriers called messenger RNA that carry genetic instructions to cells.

The shots deliver mRNA that prompts cells to make a synthetic version of the spike protein that juts from the surface of the new coronavirus. That protein triggers the immune system to defend against the virus.

After the vaccine appeared to work safely in a smaller and earlier-stage study, Pfizer and Germany’s BioNTech began in July seeking thousands of healthy volunteers for the large final-phase trial to determine whether it could be given to the public.

Like most vaccine trials, just a fraction of the subjects must become sick to evaluate whether the two-dose shot from Pfizer and BioNTech works.

For the final analysis, 164 study subjects need to become infected and develop at least one symptom. Researchers, however, designed the trial to take peeks at how the shot is performing after smaller numbers get sick.

Researchers originally planned for a first interim analysis after 32 subjects became sick. After talking with the FDA, Pfizer agreed to conduct the early peek after at least 62 subjects became sick, Dr. Jansen said.

By the time the two sides came to an agreement, the number of subjects who developed Covid-19 symptoms reached 94, Dr. Jansen said.

Pfizer officials learned about the early, or interim, analysis Sunday after speaking with the data-safety monitoring committee, Dr. Jansen said. She said Pfizer has shared the outcome of the analysis with the FDA.

The FDA has said it won’t authorize a vaccine unless it is at least 50% effective. The agency and companies wanted to see an even higher rate during an early look at an initial set of subjects to be sure it really works.

In its first look, however, the Pfizer and BioNTech vaccine worked even better than the FDA and two companies had been seeking.

The two-dose vaccine was found to be more than 90% effective at seven days after the second dose, Pfizer said, meaning that subjects were protected four weeks after their first shot.

Pfizer didn’t disclose the breakdown of how many of the 94 subjects in the analysis received the vaccine or a placebo. In the study, half receive the vaccine, while the other half receive a placebo.

Although specific safety information wasn’t available, Dr. Jansen said the data-safety monitoring committee told Pfizer officials that any side effects were similar to those in earlier testing of the vaccine.

Previously, Pfizer said some subjects in its early-stage study of the vaccine reported side effects such as fatigue, headaches and chills, and they eventually recovered. There weren’t serious side effects.

The latest timetable for the vaccine to become widely available is consistent with what Pfizer Chief Executive Albert Bourla and BioNTech co-founder and Chief Executive Ugur Sahin have suggested.

Pfizer plans to monitor patients for two years after their second dose for safety and vaccine duration.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

[billethkid]

Interesting timing of announcement!

[Bucco]

Originally Posted by billethkid

Interesting timing of announcement!

As a side note to your implication...

"Among the frontrunners, theirs is the only vaccine project that did not take funding from the White House-led Operation Warp Speed program to bolster research, development or manufacturing. BioNTech received up to 375 million euros ($445 million) in development funding from the German government, however."

Bloomberg - Are you a robot?

[Stu from NYC]

Great news!

[Boomer]

This is happy news. Go Pfizer!

[Altavia]

More details on these very early results:

Covid-19 vaccine from Pfizer and BioNTech is strongly effective, data show

Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate

Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.

The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.

The Phase 3 study is ongoing and additional data could affect results.

In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.

“I’ve been in vaccine development for 35 years,” William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told STAT. “I’ve seen some really good things. This is extraordinary.” He later added: “This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”

Although it is a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, a German company, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.

Nor is there any information yet on whether it prevents people from carrying the virus that causes Covid-19, SARS-CoV-2, without symptoms.

Because the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus. The vaccine does cause side effects, including aches and fevers, according to previously published data. Gruber said that he believed the side effect profile was comparable to standard adult vaccines, but probably worse than Pfizer’s pneumonia vaccine, Prevnar, or a flu shot.

The results have not been peer-reviewed by outside scientists or published in a medical journal, and even Pfizer and BioNTech have been given no other details about how the vaccine performed by the independent monitors overseeing the study.

Initial supplies of the vaccine, if authorized, will be limited. Pfizer says up to 50 million doses could be available globally. by the end of the year, with 1.3 billion available in 2021. There are also expected to be distribution challenges. The vaccine must be stored at super-cold temperatures, which could make it extremely difficult to deliver to many places. Pfizer has said it is confident those issues can be managed.

Although the estimate of the efficacy of the vaccine could change as the study is completed, it is close to a best-case scenario. That also bodes well for other vaccines in the late stages of testing, including those developed by Moderna, AstraZeneca, and Johnson & Johnson.

“If that headline really number really holds up, that is huge. That is much better than I was expecting and it will make a huge difference,” said Ashish Jha, the dean of the School of Public Health at Brown University. He cautioned, however, that it is always difficult to evaluate science via press release and that researchers will need to see the full results. He noted that side effects are something to watch, because even if there are no serious long-term complications, people feeling sick for a day or two could lead some to be hesitant to take a vaccine.

Both Pfizer’s vaccine and Moderna’s use messenger-RNA, or mRNA, technology, which uses genetic material to cause the body to create a protein from the virus; the immune system then recognizes the virus and learns to attack. Other vaccines in the late stages of development use genetically engineered viruses for a similar purpose, or pieces of protein that are directly injected. No mRNA product has ever been approved by regulators.

The story of how the data have been analyzed seems to include no small amount of drama. Pfizer, seeing an opportunity to both help battle a pandemic and demonstrate its research prowess, made decisions that were always likely to make its study the first of a Covid-19 vaccine to produce data — including its decision to have an independent group of researchers, known as a data safety and monitoring board, take an early look at the data in the 44,000-volunteer study before its completion.

The first analysis was to occur after 32 volunteers — both those who received the vaccine and those on placebo — had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed Covid-19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of Covid-19 — individuals with at least one symptom and a positive test result — had been reported.

That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.

In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.

Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.

This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
Gruber said that there will not be another interim analysis conducted in the study. He also said that Pfizer’s estimate that it could file for authorization of the vaccine by the third week of November was based on the assumption that the FDA would be willing to accept two-month safety data on half the volunteers in the study as initially planned, when it was to include 30,000 volunteers, not more than 44,000, as is now the case. Those discussions are ongoing.

But Gruber said he now expects that by the time of the planned meeting of the FDA’s vaccine advisory committee in December, the study’s efficacy portion could be completed, having reached 164 cases of Covid-19.

He also emphasized that although there will only be a few months of data from this study, results from earlier studies make him optimistic that immunity from the vaccine will not wane rapidly.


The study has enrolled 43,538 volunteers the companies said, and 38,955 have received their second dose. About 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.


Bourla, Pfizer’s CEO, said the results mark “a great day for science and humanity,” in a statement, saying they provide “initial evidence of our vaccine’s ability to prevent Covid-19.” He added: “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

[Velvet]

Vaccine report is on 94 subjects (out of 20,000?)... not quite earth shattering yet. But I’m hopeful.

[Stu from NYC]

Interesting as to when this info was released and how they changed the study somewhat to make sure it would not be released in October.

[44Apple]

Don't want the vaccine? Don't take it, or any others that are coming.

[rustyp]

Originally Posted by Stu from NYC

Interesting as to when this info was released and how they changed the study somewhat to make sure it would not be released in October.

Pfizer took no development money from any political source. They were not part of "warp speed" initiative. The CEO announced today they made the announcement as soon as the independent analysis board published the results. Pfizer has every right to do as they please with their own product as long as there was no development contract. If announced prior to the day in question can you imagine how many people would take credit for their hard work and investment.

[Bogie Shooter]

Originally Posted by Stu from NYC

Interesting as to when this info was released and how they changed the study somewhat to make sure it would not be released in October.

The beginning of another conspiracy theory?
The sun will/may come up tomorrow more/or/less.......

[stanley]

Originally Posted by rustyp

Pfizer took no development money from any political source. They were not part of "warp speed" initiative.

No development money but they still were/are going to make a lot of money, agreed to by the government and the present administration.

"THE U.S. GOVERNMENT HAS agreed to pay Pfizer and BioNTech nearly $2 billion for 100 million doses of the companies' potential coronavirus vaccine."

Being a newbie, it seems I am not allowed to post links.That is from USNews, July 22nd



Stan

[blueash]

Originally Posted by Velvet

Vaccine report is on 94 subjects (out of 20,000?)... not quite earth shattering yet. But I’m hopeful.

You're not understanding at all what they are reporting. Pfizer is following a group of people, about 43,000, half of whom got two doses of vaccine and half got two doses of a placebo. Then they watch to see what happens. The only way to know if a vaccine works is to either deliberately expose the participants to the disease or to allow for community exposure. If there is not any disease in a community then you will never know if the vaccine works as there will be zero cases in both groups.

So Pfizer had to just follow their participants and wait until a pre-determined number of cases had been diagnosed. Then look to see if the vaccinated group got fewer cases than the un-protected group. This report today is that they have reached their first pre-determined report level and those who got the shots were 90% less likely to get Covid than those who got two placebo doses. That is very good but does not answer a lot of questions. Pfizer will continue to follow their groups and will be reporting more data on both protection and side effects.

The efficacy study will terminate when they have about 160 people actually get Covid and then they will look at the rates in each group. They will follow longer to evaluate long term protection and long term side effects. The protocol is HERE https://pfe-pfizercom-d8-prod.s3.ama...ol_Nov2020.pdf

An independent panel is doing the analysis and all will be subject to FDA review which hopefully will be rigorous and not subject to outside influence. There is a problem with this vaccine in that it has rather severe requirements for storage, shipping and handling which is not an issue for some of the other vaccines in testing.

[Velvet]

This is how I understood the results: 4300 people in study so 2150 (half) got vaccine. 94 people got infected so .0218 or if you look at only the vaccinated .0437 i.e. less than 5%. If I had tried to present conclusions based on 5% results in my economics studies they would have laughed me out of the room.

[JGVillages]

Originally Posted by Velvet

This is how I understood the results: 4300 people in study so 2150 (half) got vaccine. 94 people got infected so .0218 or if you look at only the vaccinated .0437 i.e. less than 5%. If I had tried to present conclusions based on 5% results in my economics studies they would have laughed me out of the room.

43,000 not 4300. Numbers matter but not so much in economic studies.