https://www.politico.com/news/2020/09/23/trump-vaccine-fda-guidelines-420803 Trump says he might reject stricter FDA vaccine guidelines The FDA has reportedly proposed stricter emergency authorization standards, which are now under review by the White House Office of Management and Budget. President Donald Trump said Wednesday that the White House may not approve tougher FDA guidelines for authorizing the emergency use of any coronavirus vaccines. "That has to be approved by the White House," Trump said. "We may or may not approve it." Trump also suggested that the FDA's decision to revise the standards, first issued in June, "was a political move more than anything else." The president has repeatedly vowed that a vaccine would be available by Election Day, although prominent scientists within his administration have said it's extremely unlikely.
Johnson & Johnson COVID-19 vaccine produces strong immune response in early trial https://www.reuters.com/article/health-coronavirus-johnson-johnson-vacci-idUSKCN26G2YC A single dose of Johnson & Johnson's JNJ.N experimental COVID-19 vaccine produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, according to interim results published on Friday. The vaccine, called Ad26.COV2.S, was equally well-tolerated at two different doses, the results showed. A single shot, versus a rival two-dose approach being tested by Moderna Inc MRNA.O and Pfizer Inc PFE.N, could simplify distribution of the vaccine. However, it is unclear whether elderly people, one of the populations most at risk from the virus, will be protected to the same degree as younger people with the J&J vaccine. The trial in close to 1,000 healthy adults, which is backed by the U.S. government, began after the J&J vaccine was found in July to offer strong protection in a single dose to monkeys. Based on the current results, J&J on Wednesday kicked off a final 60,000-person trial, which could pave the way for an application for regulatory approval. The company said it expects results of that so-called Phase 3 trial by the end of the year or early next year. The results, released on the medical website medRxiv, have not been peer-reviewed. (bit.ly/2G3Ni1X) Researchers, including those from J&J’s unit Janssen Pharmaceuticals, said 98% of participants with data available for the interim analysis had neutralizing antibodies, which defend cells from pathogens, 29 days after vaccination. However, immune response results were available from only a small number of people - 15 participants - over 65 years old, limiting the interpretation. In participants older than 65, the rate of adverse reactions such as fatigue and muscle aches was 36%, much lower than the 64% seen in younger participants, the results showed, suggesting the immune response in older people may not be as strong. The researchers said more details on safety and effectiveness will follow when the study is completed. For now, the results justify why more studies are needed in larger numbers to look for serious adverse effects, Dr. Barry Bloom, a professor at Harvard T.H. Chan School of Public Health who was not involved in the J&J trial, told Reuters. “Overall, the vaccine is doing what you would expect it to do if you were to move it to Phase 3 trials,” Bloom said.
This is from the U.K. outlining the vaccine rollout issues. Coronavirus vaccine: Scientists warn it may take until 2022 to roll out to population Experts looking at possible rollout concluded it may take up to a year after a jab is possibly approved next Spring to expand it to the general population https://www.mirror.co.uk/science/covid-19-vaccine-may-not-22774413 Experts looking at possible rollout concluded it may take up to a year after a jab is possibly approved next Spring to expand it to the general population. A report has been published by the Royal Society looking at challenges developing, evaluating, manufacturing and distributing a vaccine. The verdict from its Data Evaluation and Learning for Viral Epidemics (DELVE) group will come as a shock to families desperate for a jab to save us from the pandemic and has big implications for the economy. The Government has previously suggested a working vaccine could be discovered by the turn of the year. Author Prof Nilay Shah, expert on chemical engineering at Imperial College London, said: “It doesn’t mean that within a month everyone will be vaccinated. “We are talking about another six months, nine months or maybe a year. “It will take quite a long time to rollout the vaccine even once it is approved.” Rollout would take an unprecedented logistical effort to vaccinate different age groups in GP surgeries and temporary mobile clinics. It would likely start with the over-80s then vaccinate in five-year age groups going next to the 75 to 80 age group. Prof Shah said it is likely to take a fortnight to vaccinate each five year age group meaning it will take between seven and nine months to get through the whole population. The UK’s leading experts warned that while a vaccine may initially help control outbreaks, full population immunity may take a long time after the first one is approved and social distancing is likely with us for the foreseeable future. Prof Charles Bangham, chair of immunology at Imperial College London, said: “We will have to have some restrictions that last through next year. “It will be a tapering response.”
Moderna CEO says its coronavirus vaccine won't be ready until spring of next year https://www.cbsnews.com/news/covid-vaccine-spring-2021-moderna-ceo/ Moderna CEO Stéphane Bancel said Wednesday that his company's coronavirus vaccine won't be ready for widespread public distribution until spring of next year, according to a report. The drugmaker also won't seek emergency authorization for the vaccine for frontline medical workers and other at-risk individuals until November 25 at the earliest, he told the Financial Times. Speaking at a health conference on Wednesday, Bancel said Moderna would not be ready to seek Food and Drug Administration approval for the vaccine for use in the general population until at least late January. If the vaccine is proven to be safe and effective, approval is unlikely until late March or early April. "I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine," Bancel said, according to the FT. A spokesperson for Moderna confirmed Bancel's comment at the conference noting that the company expects to have enough vaccine testing data to apply with the FDA for emergency use authorization by November 25. The timeline is a setback for Moderna, which said earlier this month that it could seek emergency authorization for a vaccine as soon as November 1. It also deals a blow to claims by President Donald Trump, which he repeated on Tuesday in his debate with Joe Biden, that a vaccine could be ready in a matter of weeks, or before the November 3 presidential election. "We're weeks away from a vaccine," Mr. Trump said on Tuesday night during the first presidential debate with Biden. Mr. Trump's statement was in response to a question from moderator Chris Wallace about why he disagrees with a prediction by the head of the U.S. Centers for Disease Control and Prevention that a vaccine won't be ready until next summer. "I've spoken to Pfizer, I've spoken to all of the people that you have to speak to — Moderna, Johnson & Johnson and others. They can go faster than that by a lot," Mr. Trump said. Moderna shares slumped $4 to just over $70 a share on the news of its revised timeline. Moderna did not respond to a request for comment. Seven potential coronavirus vaccines are now undergoing late-stage testing, though more than 170 potential treatments are under development. About a third of vaccine candidates typically make it through all three phases of testing, according to Deutsche Bank analysts.
Dr. Fauci says US could begin coronavirus vaccinations by the end of 2020 https://bgr.com/2020/10/05/coronavirus-vaccine-trials-phase-3-results-this-year-fauci-interview/ Dr. Anthony Fauci reiterated his belief that the US could begin using coronavirus vaccines before the end of the year. In a new interview, the public health expert said that he continues to be cautiously optimistic about COVID-19 vaccines. Fauci said the first answers about coronavirus vaccine efficacy and safety would be available in November or December, adding that the chance of it happening in October is unlikely. The vaccine research effort for the novel coronavirus has advanced at tremendous speed, which is an impressive accomplishment. However, the recent politicization of vaccines has undermined public trust in these experimental drugs, which is critical for immunization campaigns. An increasing number of Americans show resistance to COVID-19 vaccination, citing safety reasons. Immunization campaigns can lead to a significant drop in COVID-19 cases. But having at least one safe vaccine isn’t enough. A large percentage of the population will have to be inoculated to achieve herd immunity through vaccines. That won’t be possible initially, as there won’t be enough doses to go around. Vaccine makers will need years to meet demand, even in the US. The government has inked multi-billion deals with several frontrunners, but there’s no telling whether any of them will have anything to show for after Phase 3 trials. There’s no guarantee that any of those promising vaccines will be effective enough or safe enough to obtain regulatory approvals. With all of that in mind, Dr. Anthony Fauci is still cautiously optimistic that the US could begin vaccinating people before the end of the year. Over the past few months, several reports have claimed that the Trump administration would look to fast-track one of the many vaccine candidates that reached Phase 3 in America and issue an emergency authorization approval in time for the November 3rd election. Fauci and other officials from the FDA said that vaccine research would not compromise on safety. Soon after that, a serious adverse reaction paused the AstraZeneca/Oxford vaccine trial, as researchers scrambled to figure out why a woman in the UK developed unusual symptoms. The UK arm of the study resumed soon after that, but the US arm remains paused. We then heard that Moderna’s vaccine might be delayed by a few months, and the company might not be ready to seek approvals until late 2020. These developments seemed to indicate that only the Pfizer/BioNTech Phase 3 trial results would be ready in the coming months. Other companies have started clinical trials or reached Phase 3 as well, but they’re a few months behind the others, so their final results would need additional time as well. Fauci still expects vaccinations to start by the end of the year. “We could begin vaccinating people before the end of this calendar year,” the director of the National Institute of Allergy and Infectious Diseases said in a video interview recorded Thursday by the Greater Baltimore Medical Center. As in previous remarks, he said there’s no guarantee on the timeline, but that he’s cautiously optimistic about having an answer by November or December. He said we might have an answer in October, although that timeframe seems unlikely. The health expert also noted that there are six vaccines in tests, including five in Phase 3 trials. Of those five, two of them started the final stage of research in July (Moderna and Pfizer), and it’s one of those two that could be used by the public in November or December. Fauci also said that first responders and frontline workers would be among the first groups to get the vaccines. Older Americans will also be included in the first wave of immunizations. During the interview, Fauci said that social distancing guidelines would remain in place into the third or fourth quarter of 2021. That’s something Fauci and others have warned before. Vaccinations will have to be combined with face masks and social distancing to reduce the spread of the virus and beat the pandemic, as the first versions of the drugs will not be 100% effective. Some people might still get infected after receiving a two-dose or one-dose shot. Most vaccines require two doses, that’s why vaccinating the entire population of the US will require more than 700 million doses. (Article has video with the full interview with Fauci)
you will have to tie me down to the table in restraints to get me to take this vaccine when it first comes out.