The Food and Drug Administration (FDA) is investigating allergic reactions to the Pfizer coronavirus vaccine that were reported in multiple states after it began to be administered this week. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters late Friday that the reactions had been reported in more than one state besides Alaska and that the FDA is probing five reactions. “We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said. “I think we have at this point the right … mitigation strategy with the availability of treatment for a severe allergic reaction being at the ready, and we’ll continue to monitor it very closely,” he added. Marks said the FDA was not certain what caused the reactions but indicated a chemical called polyethylene glycol, which is present in the vaccines produced by Pfizer and BioNTech as well as by Moderna “could be the culprit.” He added that the reaction some people have experienced could be more common than once thought. “We’ll obviously be monitoring very closely what’s going on. We’re working very closely with the CDC on these, and there have been meetings between the CDC and FDA pretty much every day this week making sure we’re keeping very close track of what’s going on,” he said. The reports of allergic reactions in Alaska follow two similar cases reported last week in Britain, the first nation to approve Pfizer’s vaccine. The FDA’s current guidance says that most Americans with allergies should be cleared to take the vaccine but that people who’ve had severe reactions to other vaccines should not get vaccinated. It also said Friday that people with a history of severe allergic reactions to any components of the Moderna shot should avoid getting that vaccine. “FDA takes very seriously the safety of the medical products that we authorize and approve, and certainly in a vaccine setting, it’s one of the reasons Dr. Marks and his team, in collaboration with the CDC, has set up a very robust surveillance system for assessing safety. One of the things that FDA does very well and uniquely is really getting to the bottom of events like allergic reactions so we can completely understand the circumstances and better inform the public and also our regulatory decisions,” said FDA Commissioner Stephen Hahn.
UK’s New strain of coronavirus spreads more quickly
LONDON (Reuters) – A new strain of COVID-19 identified in the United Kingdom can spread more quickly and urgent work is under way to confirm that it does not cause a higher mortality rate, England’s Chief Medical Officer Chris Whitty said on Saturday.
“As announced on Monday, the UK has identified a new variant of Covid-19 through Public Health England’s genomic surveillance,” Whitty said in a statement.
“As a result of the rapid spread of the new variant, preliminary modelling data and rapidly rising incidence rates in the South East, the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) now consider that the new strain can spread more quickly.”
Congress averts shutdown; fight continues over pandemic aid
WASHINGTON (AP) — Congress passed a two-day stopgap spending bill Friday night, averting a partial government shutdown and buying yet more time for frustratingly slow endgame negotiations on an almost $1 trillion COVID-19 economic relief package. The virus aid talks remained on track, both sides said, but closing out final disagreements was proving difficult. Weekend sessions were on tap, and House leaders hoped for a vote on Sunday on the massive package, which wraps much of Capitol Hill’s unfinished 2020 business into a take-it-or-leave-it behemoth that promises to be a foot thick — or more. The House passed the temporary funding bill by a 320-60 vote. The Senate approved it by voice vote almost immediately afterward, and President Donald Trump signed it late Friday. Senate Majority Leader Mitch McConnell, R-Ky., said both sides remain intent on closing the deal, even as Democrats launched a concerted campaign to block an effort by Republicans to rein in emergency Federal Reserve lending powers. The Democrats said the GOP proposal would deprive President-elect Joe Biden of crucial tools to manage the economy.
Negotiations continued into Friday night but an agreement wasn’t likely before Saturday, lawmakers and aides said. House lawmakers were told they wouldn’t have to report to work on Saturday but that a Sunday session was likely. The Senate will be voting on nominations.
The $900 billion package comes as the pandemic is delivering its most fearsome surge yet, killing more than 3,000 victims per day and straining the nation’s health care system. While vaccines are on the way, most people won’t get them for months. Jobless claims are on the rise. The emerging agreement would deliver more than $300 billion in aid to businesses and provide the jobless a $300-per-week bonus federal unemployment benefit and renewal of state benefits that would otherwise expire right after Christmas. It also includes $600 direct payments to individuals; vaccine distribution funds and money for renters, schools, the Postal Service and people needing food aid. Democrats on Friday came out swinging at a key obstacle: a provision by conservative Sen. Pat Toomey, R-Pa., that would close down more than $400 billion in potential Federal Reserve lending powers established under a relief bill in March. Treasury Secretary Steven Mnuchin is shutting down the programs at the end of December, but Toomey’s language goes further, by barring the Fed from restarting the lending next year, and Democrats say the provision would tie Biden’s hands and put the economy at risk.
Ivermectin 3.5 bilion doses of this medicine has been given. Its a life saver!
Ivermectin has shown promise against Covid-19 in a clinical trial and patients receiving a five-day course of ivermectin have shown an early viral clearance and improvements of blood biomarkers compared with other two groups.
icddr,b on Monday organised a dissemination seminar to share preliminary findings of a recently concluded study that evaluated the safety and efficacy of ivermectin in combination with antibiotic doxycycline or ivermectin alone for the treatment of confirmed mild cases of Covid-19 in a hospital setting in Dhaka.
“It’s extremely important to find an affordable and easy-to-use treatment option to fight against this pandemic in low- and middle-income countries like Bangladesh. We believe a larger clinical trial with ivermectin may help facilitate decision makers to include it in the Covid-19 treatment protocol and we’re exploring for support,” he said. National public health experts, representatives from the DGHS, DGDA, BMRC, icddr,b, BPL and media were also present at the seminar. The study, conducted during July-September 2020, was funded by Beximco Pharmaceuticals Ltd, and the company also provided all the drugs used in this trial.
Pfizer says ‘millions’ of vaccine doses are waiting to be shipped — but the government hasn’t told them where to go
Vitamin D and COVID 19: The Evidence for Prevention and Treatment of Coronavirus (SARS CoV 2)
Evidence suggests that vitamin D supplementation could potentially be effective either in treatment or prevention of coronavirus disease 2019 (Covid‐19). Indeed, several studies and trials have begun to investigate the impact of vitamin D supplementation on patients with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection. In this review, we focus on the potential mechanisms of vitamin D in the pathogenesis of Covid‐19. We consider whether deficiency of vitamin D may be one of the underlying biological factors that could explain the excess mortality seen among non‐Caucasians. We also raise several important questions which need to be addressed to provide a clear picture of the extent to which vitamin D supplementation may benefit patients with Covid‐19, particularly those with underlying risk factors.
New Covid-19 strain features 17 mutations sparking fears vaccine won’t work
The new strain of Covid-19 has 17 mutations, scientists have discovered. UK experts have been analysing the new variant of coronavirus and say they have uncovered 17 alterations from the original strain of the killer disease, which they described as “a lot”. Many of the changes have happened to the virus’s spike protein, which it uses to latch onto human cells and cause illness. This is significant because most Covid-19 vaccines being developed, including the Pfizer jab that has already begun to be rolled out in the UK, are effective by targeting this protein. It is feared this could stop people becoming immune to coronavirus if they have been infected with a different strain than the vaccine can protect them against.
Scientists including England’s chief medical officer Chris Whitty have said there is “currently no evidence” that the new variant will stop the vaccine from working. The strain has also been spotted in Denmark and Australia. Professor Nick Loman, from the Institute of Microbiology and Infection at the University of Birmingham, is a member of the UK’s Covid-19 Genomics UK Consortium which is studying the mutations. He said: “There are actually 17 changes that would affect the protein structure in some way that distinguishes this variant from its kind of common ancestor of other variants that are circulating, which is a lot. “It’s striking. There’s a really long branch going back to the common ancestor, and it’s a matter of great interest as to why that is the case.” Most vaccines work by training the immune system to recognise the virus’s spike proteins and attack them when the virus tries to infect them. But if the spike proteins are altered through mutations, it is possible the virus may be able to slip past the body’s defences. The new strain, called VUI – 202012/01 was first picked up in September in Kent. It has been linked to the explosion in cases in London and the South East of England which saw the capital and parts of Essex and Hertfordshire placed into Tier 3 lockdown restrictions from today. There have been more than 1,000 confirmed cases of the new strain, mostly in southern England. The exact locations have not been revealed.
US up premarket amid stimulus expectations
LONDON (Reuters) – World stocks rose to record highs on Wednesday on the prospect of effective coronavirus vaccines and more U.S stimulas
LONDON (Reuters) – World stocks rose to record highs. Markets will look to the U.S. Federal Reserve later to see whether it hints at an extension of its stimulus programme and it thinks the economy will suffer a double-dip recession or is on the cusp of a vaccine-inspired boom. “We are not expecting a lot of fireworks from the Fed today – they have already engineered very easy monetary conditions and the tone of their messaging has been persistently dovish,” said Marija Vertimane, senior strategist at State Street Global Markets. “This is unlikely to change … in this meeting.” MSCI broadest index of Asia Pacific shares outside of Japan had followed Wall Street’s latest rise to end 0.9% higher. The region is also near record highs and up 3.8% so far in December putting it track for its best yearly performance since 2017. E-mini futures for the S&P 500 were up 0.25%, after the Dow rose 1.1% overnight and the S&P 500 and the Nasdaq climbed 1.3% each. [.N].
Optimism over a $1.4 trillion U.S. spending package increased after House of Representatives Speaker Nancy Pelosi invited other congressional leaders to meet late on Tuesday to put together a deal to be enacted this week.
“The odds are that this deal is more than the $500 billion the Republicans proposed and likely less than the $900 billion of the joint Republican/Democrat committee proposal,” said Sebastien Galy, macro strategist at Nordea Asset Management. “It is rightfully welcomed by the markets, but the size of the fiscal package is the issue.” Progress on rolling out vaccines continued after Moderna Inc’s COVID-19 vaccine appeared set for regulatory authorization this week. The United States also expanded its rollout of the newly approved vaccine developed by Pfizer Inc. and BioNTech SE. Analysts expect guidance later in the day on when and how the Fed might change its bond purchases. The dollar fell to its lowest since April 2018 against a basket of currencies. Derek Halpenny, MUFG’s head of research, said that “underlines high expectations that the Fed will today deliver a message of continued loose monetary policy for a considerable period to come”. The euro rose above $1.22 for the first time since April 2018 and euro zone bond yields edged up, after data showed better-than-expected business activity in the bloc this month. [GVD/EUR] The pound rose to 12-day highs against the dollar and a one-week high against the euro. It gained after European Commission President Ursula von der Leyen said there was progress on a Brexit trade deal and the next few days would be critical. The dollar fell to a month-and-half low of 103.30 against the Japanese yen. In Asia, stock markets gained. Australian shares rose 0.8%, South Korea’s KOSPI was up 0.4% and Japan’s Nikkei added 0.2%. China’s blue-chip CSI 300 index added 0.15% and Hong Kong’s Hang Seng index climbed 0.86%.
FDA: Moderna vaccine meets expectations for emergency use
- Moderna’s vaccine could be administered to the public as early as next week if it wins emergency use authorization from the FDA.
- The FDA staff endorsement comes two days before the agency’s Vaccines and Related Biological Products Advisory Committee, a group of outside medical advisors, is scheduled to review it.
- The committee is expected to recommend Moderna’s vaccine for emergency use.
The staff of the Food and Drug Administration on Tuesday endorsed the emergency use of Moderna’s coronavirus vaccine, a critical step forward in winning formal clearance to be administered to the public as early as next week. The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Thursday to review Moderna’s request for emergency use authorization. The group of outside medical advisors recommended Pfizer’s vaccine for emergency use last Thursday, and the FDA approved it the next day. The committee is expected to recommend Moderna’s vaccine. The FDA doesn’t have to follow the committee’s recommendation, but it often does. The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.” “FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” it said. The announcement helped Moderna’s stock rise 1.5% just before the opening bell. The documents are “enormously encouraging,” said Dr. Paul Offit, a voting member on the committee, adding they show there are now two highly effective vaccines. He voted in favor of recommending Pfizer’s vaccine last week. Moderna is asking the FDA to approve the use in people age 18 and over, while Pfizer’s vaccine was cleared for use in people age 16 and older. The scant data in younger teens was a sticking point for the few members of the advisory committee who voted against authorizing Pfizer’s vaccine last week. The FDA said it recommends tracking cases of Bell’s palsy, a condition that causes a sudden freezing or weakness in facial muscles, if the vaccine is cleared for use. The agency said there were three cases in the vaccine group and one in the placebo group among the 30,000 trial participants. “Currently available information is insufficient to determine a causal relationship with the vaccine,” the agency wrote. The most common side effects were pain at the injection site, fatigue, headache, muscle pain and chills, the FDA said, adding more severe reactions were more common after the second dose. Trial participants told CNBC in September the symptoms were uncomfortable, and at times intense, the participants said they often went away after a day, sometimes sooner, and that it was better than getting Covid-19. The FDA said 13 deaths were reported as of Dec. 3, with six in the vaccine group. Two deaths in the vaccine group were people over age 75 with preexisting conditions, the agency said. One case was a 72-year-old vaccine recipient with Crohn’s disease and short bowel syndrome who was hospitalized for thrombocytopenia and acute kidney failure. Moderna submitted its Covid vaccine data to the FDA on Nov. 30. It said a final analysis of its phase three clinical trial found the vaccine was more than 94% effective in preventing Covid, was safe and appeared to fend off severe disease. Its vaccine uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response. The documents published offer a glimpse of the FDA’s view of the vaccine. If the FDA approves the vaccine, it would be the second one for emergency use in the U.S., behind the Pfizer-BioNTech vaccine. Gen. Gustave Perna, who oversees logistics for President Donald Trump’s vaccine program Operation Warp Speed, said Monday that the U.S. plans to ship just under 6 million doses of Moderna’s vaccine once the FDA approves emergency use. Such an authorization isn’t the same as a full approval, which can typically take months longer. Moderna, like Pfizer, has only submitted two months of follow-up safety data, but the agency usually requires six months for full approval. Pfizer’s vaccine was authorized for people 16 and older. Cambridge, Massachusetts-based Moderna has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at negative 4 degrees Fahrenheit. By comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit. The federal government announced last week that it will purchase an additional 100 million doses of Moderna’s vaccine. The U.S. entered an agreement with Moderna in August to acquire 100 million doses for about $1.5 billion. Moderna said that month it was charging $32 to $37 per dose for its vaccine for some customers, under cheaper “pandemic pricing.” The company said it was in discussion for larger volume agreements that will have a lower price.
New Covid strain ripping through the South is forcing 11million more Brits into Tier 3 lockdowns
A NEW Covid strain which may spread even quicker is ripping through the South – as Matt Hancock last night plunged 11million more Brits into Tier 3. The Health Secretary told MPs more than 1,000 cases of the new “variant” has been discovered in up to 60 places across the UK – and the World Health Organisation has been informed.London, parts of Essex and Hertfordshire, will move into Tier 3 from midnight tonight. It now means 34million people – 61 per cent of the population – will face the toughest rules. Brits in those areas can’t see friends and family they don’t live with indoors or outdoors – unless they are in a support bubble. But shops, gyms and schools will remain open. Pubs and restaurants will be forced to shut, except for takeaway and delivery. Mr Hancock last night urged Londoners to follow the example of Liverpool and Manchester to drive the virus down again. In a bombshell announcement, Mr Hancock said the mutation was spreading at a quicker pace than the original virus. But experts stressed that the new strain was not the cause of the tier changes. Mr Hancock said: “We have identified a new variant of coronavirus which may be associated with the faster spread in South East England. “It is growing faster than existing variants, with over 1,000 cases. He told the Commons: “Initial analysis suggests that this variant is growing faster than the existing variants.” There are over 60 areas affected, which is “growing rapidly” and similar strains have been identified in other countries, he said. He added: “We’ve seen very sharp exponential rises of the virus across London, Kent parts of Essex and Hertfordshire. “We must take fast and decisive action.” At last night’s press conference he said the “rise in transmission and this new variant should be a warning to all” that “personal responsibility” was needed going into Christmas. He warned: “Respect the rules where you are, don’t ease up on simple things. “When the virus is growing exponentially, there is not a moment to spare.” However, the Government insisted Covid rules will still be lifted for five days over Christmas. Mr Hancock begged everyone to reduce their social contacts in the next few weeks to crack down on cases. He also recommended Brits self-isolate as much as they can before seeing elderly or other vulnerable relatives over Christmas. He told the Downing Street press conference: “Be extremely careful now about who you see. That’s the way to see loved ones in a socially distanced way.” The new measures take the total number of people in Tier 3 in England to 34million, and he suggested more areas could be plunged into the highest tier later this week too. There are hopes some areas in the North could be downgraded to Tier 2, which currently covers 21.5million. He said: “This moment is a salutary warning for the whole country.”This isn’t over yet.” Professor Whitty insisted it was difficult to know if the new variant was spreading quicker or not – and that it would be “surprising but not impossible” it would not react to a vaccine. And he suggested the reason Tier 3 has not worked in areas like Kent was because London – where many people travel in and out for work – was still in Tier 2. He said there was no point in surrounding counties being in a higher tier than London while the captial’s cases are rising so quickly. However, he slapped down suggestions that the reason the Tiers were being ramped up was because of the new strain – and insisted that cases were rising across the board. The World Health Organsiation and Public Health England are continuing to look into the new killer strain. But there was no evidence to suggest the mutation is more deadly. Crucially, there is also no suggestion it cannot be beaten by the vaccine. TOP scientists have urged Brits not to panic over the new strain of Covid. Virus experts Prof Alan McNally and Dr Jeremy Farrar both played down the threat of the latest mutation. Prof McInally, from the University of Birmingham, said: “It is important to keep a calm and rational perspective on the strain as this is normal virus evolution and we expect new variants to come and go and emerge over time. “It’s too early to be worried or not by this new variant, but I am in awe of the surveillance efforts in the UK that allowed this to be picked up so fast.” Dr Farrar, from the Wellcome Trust, added: “This is to be expected. The pressure on the virus to evolve is increased by the fact that millions of people have now been inf Mr Hancock said: “It shows we’ve got to be vigilant and follow the rules and everyone needs to take personal responsibility not to spread this virus,” he said. He added that in some areas the doubling time of the number of new cases is as short as seven days. The strain was first detected in Kent last week – and it’s not yet known if it’s a home-grown mutation or has come in from abroad. And it’s understood that two weeks of lab testing is needed for experts to be completely sure that it will still be able to be tackled by the vaccine. Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said it was too early to draw any conclusions yet and stressed it could be by chance. He said: “The genetic information in many viruses can change very rapidly and sometimes these changes can benefit the virus – by allowing it to transmit more efficiently or to escape from vaccines or treatments – but many changes have no effect at all. “Even though a new genetic variant of the virus has emerged and is spreading in many parts of the UK and across the world, this can happen purely by chance. “Therefore, it is important that we study any genetic changes as they occur, to work out if they are affecting how the virus behaves, and until we have done that important work it is premature to make any claims about the potential impacts of virus mutation.” Alan McNally, a professor in microbial evolutionary genomics at the University of Birmingham, stressed that Brits should remain “calm and rational” following the news. He said: “Huge efforts are ongoing at characterising the variant and understanding its emergence. “It is important to keep a calm and rational perspective on the strain as this is normal virus evolution and we expect new variants to come and go and emerge over time. “It’s too early to be worried or not by this new variant, but I am in awe of the surveillance efforts in the UK that allowed this to be picked up so fast.” The decision to put the capital in Tier 3 came three days earlier than expected because ministers and officials were shocked by rising cases. ]Experts said the main driver behind the spike was Christmas shopping and increased socialising. Mr Hancock suggested Londoners should avoid Oxford Street and shop for their gifts online to help stop the spread of the virus. And he said travel to and within Tier 3 areas is discouraged. T]he Health sec said: “It is recommended that people should minimise travel unless it is necessary in a Tier 3 area and should minimise travel where it is necessary to a Tier 3 area.