Will vaccines work against the U.K. coronavirus variant?

 

• "We don't know at the moment if our vaccine is also able to provide protection against this new variant," but because the proteins on the variant are 99% the same as the prevailing strains, BioNTech (NASDAQ:BNTX) has "scientific confidence” in the vaccine.
• "The likelihood that our vaccine works... is relatively high," CEO Ugur Sahin declared, saying the company is currently conducting further studies and hopes to have certainty within the coming weeks.
• Dr. Moncef Slaoui, head of Operation Warp Speed, also expects Pfizer's (NYSE:PFE) and Moderna's (NASDAQ:MRNA) COVID-19 shots will be effective against a new mutation of the virus, dubbed B117. The chances one set of mutations would completely alter the structures found around the spike proteins "are extremely low," he declared.
• "It stands to reason that this mutation isn't a threat, but you never know. We still have to be diligent and continue to look," added Dr. Nelson Michael, director of the Center for Infectious Diseases Research at the Walter Reed Army Institute of Research. U.S. army scientists have already started doing a computer analysis on genetic sequences of the new U.K. variant, and if there's additional concern, studies would need to be done in the laboratory and on animals.
• World Health Organization officials meanwhile said the coronavirus is mutating "at a much slower rate" than seasonal influenza and "so far, even though we've seen a number of changes and a number of mutations, none has made a significant impact on either the susceptibility of the virus to any of the currently used therapeutics, drugs, or the vaccines under development, and one hopes that that will continue to be the case."
• While many nations have banned travel with countries where the strain has been identified, former FDA chief Dr. Scott Gottlieb doesn't think that's necessary in the U.S., as the strain is "already" present in the population. "We're going to have an epidemic that continues to build over the course of the next three or four weeks, we'll reach a peak, and then we'll start to see infection rates decline as we see vaccinations get rolled out."
• Related: AstraZeneca (NYSE:AZN), Johnson & Johnson (NYSE:JNJ), Novavax (NASDAQ:NVAX), Inovio Pharmaceuticals (NASDAQ:INO), Dynavax (NASDAQ:DVAX), GlaxoSmithKline (NYSE:GSK), iBio (NYSEMKT:IBIO), Altimmune (NASDAQ:ALT) and VBI Vaccines (NASDAQ:VBIV).
• https://seekingalpha.com/news/3646502-will-vaccines-work-against-u-k-coronavirus-variant

Pfizer and Moderna are testing their vaccines against UK coronavirus variant

 Pfizer and Moderna are testing their coronavirus vaccines to see if they work against the new mutated version of the virus that's recently been found in the United Kingdom and other countries, according to company statements.

"Based on the data to date, we expect that the Moderna vaccine-induced immunity would be protective against the variants recently described in the UK; we will be performing additional tests in the coming weeks to confirm this expectation," according to the Moderna statement.

Pfizer said it is now "generating data" on how well blood samples from people immunized with its vaccine "may be able to neutralize the new strain from the UK."

The novel coronavirus has mutated before, and both companies say they've found that their vaccines worked against other variations of the virus.

The statements from the two companies reflect the increasing global concern about a new variant of the novel coronavirus that has rapidly spread through the UK.

Experts are unsure of the importance of this mutation, yet a number of countries, including Canada, have imposed restrictions on travelers from the UK.

he United States has not done so, but the White House is considering requiring travelers from the UK to present proof of a negative coronavirus test before arriving in the US, two administration officials told CNN on Monday.

US Surgeon General Jerome Adams said the UK variant "doesn't change what we need to do" in regards to staying protected.

"What's important for people to understand as this doesn't change what we need to do," he said. "We need to wear masks, wash hands, watch our distances and wait on gatherings, and we need to get vaccines, get vaccinated when those become available to us."

Variant or not, the US has failed to limit the spread of Covid-19 as is. The winter solstice on Monday marked the darkest day of the year and provided a tidy metaphor for this period of the pandemic. The US reported about 191,000 new Covid-19 cases and 1,700 new deaths on Monday as more than 115,000 people were hospitalized with the virus, a record high.

The outbreaks are also not confined to any one region, as in earlier in the pandemic. Adjusted for population, the states with the most new cases over the past week are Tennessee, California and Rhode Island, according to data from Johns Hopkins University.

Yet just as the days are set to get longer and spring's renewal nears, so too is the promise of widespread vaccinations. More than 614,000 doses of the vaccine have been administered, according to the US Centers for Disease Control and Prevention, and tens of millions more are expected in the coming months.

Dr. Fauci says variant is probably in US

Dr. Anthony Fauci, the director of the National Institutes of Allergy and Infectious Diseases, said Monday that the UK coronavirus variant is probably already in the US.

"You have to make that assumption," Fauci told PBS Newshour's Judy Woodruff on Monday.

"When you see something that is pretty prevalent in a place like the UK, there are also mutations that we're seeing in South Africa, and given the travel throughout the world, I would not be surprised if it's already here."

"Certainly it's not yet the prevalent one, the way it seems to have assumed that prevalent nature in the UK, but we're going to be looking for it right now, and I'm sure sooner or later we're going to run into it and find it," he added.

Mutations in the virus are not out of the ordinary, and most have no noticeable impact, Fauci said. Researchers are still trying to determine if the UK variant is more transmissible, but Fauci said said it doesn't seem to have any impact on the deadliness of the virus.

Fauci said he thinks a UK travel ban is premature because there's not enough evidence to warrant it. He said he prefers considering the possibility of mandatory testing of travelers from the UK.

Some researchers who are examining the genome of the UK variant told CNN they have concerns that this variant's mutations might somewhat diminish the effectiveness of the vaccine.

"You could imagine some modest hit in vaccine efficacy, which wouldn't be good, but I don't think it would break the vaccine," said Trevor Bedford, an associate professor in the vaccine and infectious disease division of the Fred Hutchinson Cancer Research Center.

Other experts, though, have been skeptical of any impact on the vaccines.

"It doesn't make people more sick and it doesn't seem to have any impact on the protective nature of the vaccine that we're currently using," Fauci said.

Moncef Slaoui, chief scientific adviser for Operation Warp Speed, said during a news briefing Monday that there is no "hard evidence" that the variant is more transmissible.

"There is clear evidence that there is more of it in the population," he said. "Whether it's due to a higher capacity to transmit or whether it's due to the fact that we now are able to sequence all the time and see the virus, while when it was seeding the population in the southeast of the UK, we were not, or they were not, looking for this particular variant."

https://www.cnn.com/2020/12/22/health/us-coronavirus-tuesday/index.html

AstraZeneca-Amgen drug fails main goal of late-stage asthma study

 AstraZeneca and Amgen said on Tuesday their experimental asthma drug tezepelumab failed to meet the main goal of reducing patients' dependence on steroids, while keeping the respiratory condition in check in a late-stage trial.

The 48-week trial involved patients with severe asthma who required oral corticosteroids on top of the standard regimen, the drugmakers said in a joint statement, adding that the drug was compared against placebo.

Tezepelumab works by blocking a type of immune protein called thymic stromal lymphopoietin (TSLP). TSLP belongs to the cytokine group, that is responsible for sending messages and sounding an alarm to the body's immune system, and can also trigger inflammation.

"Our initial analysis ... indicates that the trial design may have contributed to the result of the primary endpoint," said Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca.

Data from the clinical study will be analysed further, the companies said, and details will be presented at a forthcoming medical conference.

Tezepelumab had met the primary goal of another trial by significantly reducing asthma attacks for people with severe forms of the condition compared to a placebo, data in November showed.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Amgen-drug-fails-main-goal-of-late-stage-asthma-study-32066227/

U.S. could require negative COVID-19 tests for passengers from Britain

 The U.S. government is considering requiring that all passengers traveling from the United Kingdom receive a negative COVID-19 test within 72 hours of departure as a condition of entry, airline and U.S. officials briefed on the matter said Monday.

A White House coronavirus task force discussed requiring pre-flight tests after a meeting on Monday regarding the emergence of a highly infectious new coronavirus strain in Britain that prompted dozens of countries to close their borders to Britain.

Airline and U.S. officials said requiring testing for UK arrivals won backing among task force members. The White House has yet to make a final decision on the matter, they said.

Earlier, airlines operating flights from London to John F. Kennedy International Airport voluntarily agreed to a request from New York Governor Andrew Cuomo that they only allow passengers who test negative to fly.

The three airlines - British Airways, Delta Air Lines and Virgin Atlantic - said they would begin screening passengers on those routes this week.

Major Transatlantic carriers, which have drastically cut flights during the pandemic, have been implementing pilot COVID-19 testing between some U.S. and European cities as a way to create safe “travel corridors” and help reduce quarantines and government restrictions.

Last month, task force members recommended the White House end the restrictions that ban most non-U.S. citizens from entering the United States if they have been in the United Kingdom, Ireland, Brazil, and the 26 countries in the so-called Schengen border-free area of Europe within the previous two weeks.

Some airline officials hoped the addition of new testing requirements could help suspend the entry restrictions.

On Nov. 21, the Centers for Disease Control and Prevention issued new recommendations calling for testing before and after international air travel.

CDC last month recommended international air travelers get tested with a viral test 1-3 days before their flight to reduce spread during travel and travelers should get tested 3-5 days after travel and stay home for 7 days.

https://www.reuters.com/article/health-coronavirus-usa-britain/u-s-could-require-negative-covid-19-tests-for-passengers-from-britain-sources-idUSKBN28W0AW

After months of inaction, Congress approves $892B COVID-19 relief package

 The U.S. Congress on Monday approved an $892 billion coronavirus aid package, throwing a lifeline to the nation’s pandemic-battered economy after months of inaction, while also keeping the federal government funded.

President Donald Trump is expected to sign the package into law.

Following days of furious negotiation, both legislative chambers worked deep into the night to pass the bill - worth about $2.3 trillion including spending for the rest of the fiscal year - with the House of Representatives first approving it and the Senate following suit several hours later in a bipartisan 92-6 vote.

The virus relief bill includes $600 payments to most Americans as well as additional payments to the millions of people thrown out of work during the COVID-19 pandemic, just as a larger round of benefits is due to expire on Saturday.

The stimulus package, the first congressionally approved aid since April, comes as the pandemic is accelerating in the United States, infecting more than 214,000 people every day and slowing the economic recovery. More than 317,000 Americans have died.

House Speaker Nancy Pelosi, a Democrat, said she supported the virus relief bill even though it did not include the direct aid for state and local governments that Democrats had sought. She said they would try for it again after Democratic President-elect Joe Biden takes office on Jan. 20.

The bill, she said, “doesn’t go all the way but it takes us down the path.”

Republican Representative Hal Rogers, who also supported the package, said “it reflects a fair compromise.”

At 5,593 pages, the wide-ranging bill that also spends $1.4 trillion on an array of federal programs through the end of the fiscal year in September, is likely to be the final major piece of legislation for the 116th Congress that expires on Jan. 3. Congress included a measure continuing current levels of government spending for seven days, ensuring no interruption to federal operations.

MCCONNELL CLAIMS VICTORY

It has a net cost of roughly $350 billion for coronavirus relief, Republican Senate Majority Leader Mitch McConnell said, adding that more than $500 billion in funding comes from unspent money Congress had authorized.

Both Democrats and Republicans claimed victory but McConnell argued that the final bill came close to what Democrats rejected months ago as insufficient.

The measure ended up far less than the $3 trillion called for in a bill that passed the Democratic-controlled House in May, which the Republican-controlled Senate ignored.

“Compare the shape of this major agreement with the shape of what I proposed all the way back in late July. Yes, some fine details are different,” McConnell said in a statement after the vote. “There is no doubt this new agreement contains input from our Democratic colleagues. It is bipartisan. But these matters could have been settled long ago.”

A months-long impasse on relief that played in the background of the U.S. presidential election was broken after a group of centrist lawmakers from both parties put forward a proposal that served as a framework for the final bill.

Even so, the bill was so unwieldy that it caused congressional computers to malfunction. It includes a hodgepodge of tax breaks and other proposals that failed to pass on their own, including two new Smithsonian museums and limits on surprise medical billing. [L1N2J10ZA]

The legislation also renews a small-business lending program by about $284 billion and steers money to schools, airlines, transit systems and vaccine distribution.

PUBLIC COMPANIES EXCLUDED

The small-business loan and grant program, known as the Paycheck Protection Program, would exclude publicly traded companies from eligibility.

Amid reports that the Trump Organization received past aid, the bill contains disclosure requirements for the president, vice president, heads of Cabinet departments, lawmakers and spouses and prohibits those individuals from receiving loans in the future.

State and local governments, which are struggling to pay for the distribution of newly approved COVID-19 vaccines, would receive $8.75 billion from Washington, with $300 million of that targeted at vaccinations in minority and high-risk populations.

The deal, worked out in a rare weekend session of Congress, omits the thorniest sticking points, which included Republicans’ desire for a liability shield to protect businesses from coronavirus-related lawsuits as well as Democrats’ request for a large outlay of money for cash-strapped state and local governments.

If signed into law, the bill would be the second-largest stimulus package in U.S. history, behind the roughly $2 trillion aid bill passed in March. Experts said that money played a critical role as social-distancing measures shuttered wide swaths of the economy.

https://www.reuters.com/article/us-health-coronavirus-usa-congress/after-months-of-inaction-u-s-congress-approves-892-billion-covid-19-relief-package-idUSKBN28V176

European shares rebound despite fears over virus mutation

 

• London +0.23%. U.K. GDP grew by a record 16% in Q3, revised up from a previous estimate of 15.5%. But that still did not make up for its 18.8% slump in Q2, when much of the economy was shut down.
• The data also showed that the economy was 8.6% below 2019 mark, less than an initial estimate of 9.7%.
• Also, many other nations have closed their doors for U.K. due to worries over a highly infectious new coronavirus strain.
• Germany +1.34%. Germany January GfK consumer confidence -7.3 vs -7.6 expected, prior -6.8 (revised).
• France +1.34%.
• U.K. and France aim to restart freight as queues grow.  France's Europe minister Clément Beaune said any plans agreed upon related to France's border closure will come into effect from Wednesday.
• The U.K. and EU remain deadlocked over post-Brexit trade relations as the Dec. 31 deadline approaches.
• Sterling extended Monday’s losses on Tuesday, falling another 0.5% to around $1.34.
• https://seekingalpha.com/news/3646491-european-shares-rebound-despite-fears-over-virus-mutation

A Better Way to End the Pandemic Quickly?

 The FDA now has authorized vaccines from both Pfizer/BioNTech and Moderna. However, the news is not all good. We are a country of about 325 million people, yet, in the near term, there will only be enough vaccine for about 20 million people. Hopes that the majority of the population will be vaccinated by spring have given way to more pessimistic projections of summer or even fall. What are we to do?

There are two strategies that will allow us to end the epidemic in a more timely fashion. Both solutions require that, at least in the short run, we use the available supply of vaccine more efficiently. First, we should not use the limited supply of vaccine for people who do not need it.

There is convincing evidence that people who are known to have been infected already have immunity to SARS-CoV-2. As of December 21, there have been 77 million cases of COVID-19 reported worldwide. A group that tracks confirmed reinfections has documented only 30 cases. To be fair, this may be an underestimate. But even if we inflated the number of known reinfection cases 10-fold, the incidence of infection in the active vaccine arm of the Moderna trial would still be more than 200 times greater.

In Pfizer's trial, although the published summary noted that exclusion criteria included a medical history of COVID-19, the FDA briefing document showed that 1,093 persons (526 in the vaccine group and 567 in the placebo group) were positive for SARS-CoV-2 at baseline (via a positive antibody, positive PCR test, or medical history of COVID-19). In this group, there were only two incident cases, one in each arm of the trial. Similarly, in the Moderna trial, only one person in the placebo arm with SARS-CoV-2 antibodies at baseline developed COVID. Overall, the literature suggests the efficacy of prior infection for preventing reinfection is over 99%. At a minimum, we feel that persons with COVID-19 infection in the last 90 days should not be immediately prioritized.

Finally, the number of people who have had a prior infection may be greater than realized. The CDC estimates there are currently eight undiagnosed COVID-19 cases for each diagnosed case. By December 30, it is estimated that about 20 million people in the U.S. will have been infected with the coronavirus. That means that 160,000,000 Americans, or nearly half the population, will have immunity, dramatically limiting the need for vaccine.

Frequent side effects were reported with these vaccines, though typically short term and self-limited. However, a few cases of Bell's palsy and severe allergic reactions have been reported. Of perhaps greater concern is that these two vaccines represent a new technology and any long-term effects remain unknown. With the vaccine in short supply, what rationale is there for vaccinating someone with near-zero risk of future disease?

The second way to stretch the limited supply of vaccine is to delay the second dose. The current plan is to give two doses, 21 days apart for the Pfizer product and 30 days apart for Moderna's. Alternatively, all available doses could be given immediately, doubling the number of people who could be reached. Both Pfizer and Moderna report that the efficacy of a single dose is only about 50%. But a closer look at their incidence curves suggests that immunity appears to be maximized about 14 days after the first dose. In the Moderna trial, for example, most of the cases in the vaccine arm occurred during the first 2 weeks following the initial dose. We recognize that the vaccine was developed and tested on the assumption that two doses are necessary. Yet, the trial data suggest that a single dose provides substantial immunity. During this severe pandemic, it seems reasonable to use the available supply to reach as many people as possible in the short term. Delaying the second dose would maximize limited resources and could reduce serious illness and death. A recent projection suggests the U.S. will receive 40 million doses of the two mRNA vaccines by early 2021. A rough calculation suggests that vaccinating 40 million persons with these 40 million doses versus 20 million persons with two doses each could prevent over 100,000 severe cases and save over 10,000 lives

We understand that these suggestions depart from the current protocol and that the protection by a single dose of these vaccines beyond 1 month is unknown. Yet, the situation is urgent. We need to use the limited supply of vaccine to have the most benefit for the most people and to prevent as many cases of severe disease and death as possible. Once the epidemic begins to wane, we would then reexamine the need for second doses and for vaccinating those who have already been infected.

Michael H. Criqui, MD, MPH, is a Distinguished Professor at the University of California San Diego School of Medicine and past Chief of the Division of Preventive Medicine. He is an epidemiologist and preventive medicine specialist.

Robert M. Kaplan, PhD, is a faculty member at Stanford Medical School's Clinical Excellence Research Center, a former associate director of the National Institutes of Health, and former chief science officer for the U.S. Agency for Health Care Research and Quality.

https://www.medpagetoday.com/infectiousdisease/covid19/90358