Covid-19 vaccine from Pfizer and BioNTech shows positive results

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Pfizer-J J-Biosimilar

The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccines.

Source: Stat news

By Matthew Herper

An experimental Covid-19 vaccine being developed by the drug giant Pfizer and the biotech firm BioNTech spurred immune responses in healthy patients, but also caused fever and other side effects, especially at higher doses.

The first clinical data on the vaccine were disclosed Wednesday in a paper released on medRXiv, a preprint server, meaning it has not yet been peer-reviewed or published in a journal.

“We still have a ways to go and we’re testing other candidates as well,” said Philip Dormitzer, the chief scientific officer for viral vaccines at Pfizer’s research laboratories. “However, what we can say at this point is there is a viable candidate based on immunogenicity and early tolerability safety data.”

Surgery has long been ignored as a gateway to overreliance on opioids — and action is urgently needed to effectively treat postoperative pain while minimizing opioid exposure.

The study randomly assigned 45 patients to get one of three doses of the vaccine or placebo. Twelve received a 10-microgram dose, 12 a 30-microgram dose, 12 a 100-microgram dose, and nine a placebo. The 100-microgram dose caused fevers in half of patients; a second dose was not given at that level.

Following a second injection three weeks later of the other doses, 8.3% of the participants in the 10-microgram group and 75% of those in the 30-microgram group developed fevers. More than 50% of the patients who received one of those doses reported some kind of adverse event, including fever and sleep disturbances. None of these side effects was deemed serious, meaning they did not result in hospitalization or disability and were not life-threatening.

The vaccine generated antibodies against SARS-CoV-2, the virus that causes Covid-19, and some of these antibodies were neutralizing, meaning that they appear to prevent the virus from functioning. Levels of neutralizing antibodies were 1.8 to 2.8 times the level of that in the recovered patients.

It’s not certain that higher antibody levels will lead to immunity to the virus. To prove that, Pfizer will need to conduct large studies that aim to prove that people who have received the vaccine are at least 50% less likely to become infected. Those studies are expected to begin this summer, mostly in the United States.

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2 replies

  1. nvestors were anticipating the first vaccine might arrive in the autumn after reports of President Donald Trump pressuring health officials in his re-election bid. Drug and vaccine developers including Johnson & Johnson, Merck & Co., Pfizer Inc. and Moderna Inc. are taking part in the administration’s “Warp Speed” program. The government program is meant to further efforts to develop a vaccine faster than any have been developed before, though details are scant.

    Pfizer rallied as much as 5.6% on Wednesday after early data with partner BioNTech SE showed promising effects for a vaccine candidate, while small-cap vaccine developer Inovio Pharmaceuticals Inc. plunged 27%. Moderna, one of the leaders in the space, fell 7.9%. All three vaccine programs would likely need longer-term results to clearly establish safety, according to Porges. DNA vaccines in particular, like Inovio’s, may be “held to a more stringent standard given general concerns about risks of genetic integration.”

    Porges doesn’t see a 2020 vaccine happening, and “the success of that effort is by no means a foregone conclusion,” he said. Instead, he predicts a full vaccine approval may come in another two or three years, with widespread adoption taking another year after that.

    Should a vaccine be approved, getting enough Americans to vaccinate will be another hurdle to turning the tide on Covid-19. Yesterday’s guidelines are meant to depoliticize the government’s vaccine efforts so people aren’t afraid to get vaccinated, Beacon Policy Advisors founder Brandon Barford said in a phone interview.

    “They are trying to put out very prescriptive guidelines so outside experts can quickly try to validate the studies and help with the public health efforts,” Barford said. The stock market has not incorporated “enough analysis surrounding the politics of a vaccine and how even if the science delivers, our political leaders may fail the test by overly politicizing the process to a point that it will take longer than anticipated for a sufficient number of people to agree to be vaccinated to reach herd immunity in the U.S.,” according to Barford.

    But the tone of U.S. regulators should put citizens at ease as it “suggests that regardless of political pressure, the FDA continues to apply sound regulatory judgment and expertise to the development of all medical products, particularly vaccines, regardless of the severity of the economic, political, or public health urgency of the current situation,” Porges said, “For that integrity, the general public, the biopharma industry, and all of its investors should be grateful.”

    https://www.bloomberg.com/?sref=eGA8az79

  2. While the manufacturer has not given a specific release date, Dormitzer assured ABC News Pfizer is “currently on track” to meet the goal of producing 100 million doses by the end of the year and another 1.2 billion doses in 2021.

    “The goal that we’ve set is to distribute millions of vaccine doses in 2020 and executing on that, of course, means everything has to go well,” he said. “We need the regulatory approval to do so. But that is our plan.”

    https://www.yahoo.com/gma/early-trial-results-keep-pfizer-vaccine-development-track-235001901.html

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