Britain’s government is working on a recovery plan for the country’s COVID-battered economy, a source said on Sunday, as ministers direct their attention to trying to restore growth for businesses hit hard by the pandemic.
Prime Minister Boris Johnson and finance minister Rishi Sunak have broken with the traditional, pro-market instincts of their Conservative Party and are on course to spend 280 billion pounds of public money in the current financial year to support jobs and businesses.
The government source said the finance ministry and cabinet office were working on a recovery plan after the Sunday Times reported that the government would provide a long-term blueprint that is likely to mean high state spending for a decade.
The Sunday Times also said Sunak would use his March 3 budget to extend government relief, including the furlough job protection scheme, business support loans, cuts in value-added tax, and perhaps the cut to stamp duty on property purchases which is due to expire at the end of March, until the virus is under control.
Earlier this month, a leading British employers group called for another 7.6 billion pounds of immediate government help, saying they could not wait until the March budget.
The Sunday Times said Sunak would also announce that the support programmes will be phased out, probably this autumn, in favour of “a plan for jobs” to kick-start employment and a “plan for growth” to promote new industries.
Columbia University researchers and Regeneron have independently confirmed findings; data included in bioRxiv paper and submitted for peer-reviewed publication
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that researchers in Dr. David Ho'sColumbia University lab and Regeneron scientists have independently confirmed that REGEN-COVTM (casirivimab and imdevimab antibody cocktail) successfully neutralizes the circulating SARS-CoV-2 variants first identified in the UK (B.1.1.7) and South Africa (B.1.351). Columbia's findings were included in a paper posted to bioRxiv and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to antibody neutralization.
Both teams of researchers assessed in vitro neutralization potency of numerous COVID-19 antibodies (including those that have received emergency authorization and those still in development) against various mutated strains of the virus. Although some antibody therapies were no longer effective against some of these variants, the REGEN-COV antibody cocktail continued to neutralize all variants tested. REGEN-COV, which consists of the highly potent neutralizing antibodies imdevimab (REGN10987) and casirivimab (REGN10933), retained its potent neutralizing capability against the B.1.1.7 variant, with both antibodies retaining their potency. REGEN-COV also retained its highly potent neutralizing capacity against the B.1.351 variant; imdevimab retained its potency against this variant, and, while casirivimab potency was reduced, it was still comparable to the potency that other single antibodies in development have against the original virus.
News from U.S. manufacturer Moderna that its COVID-19 vaccine is still “expected to be protective” against a virus variant first detected in South Africa came as a relief to scientists and the public. But the 25 Januaryannouncementincluded a caveat: Antibodies triggered by the vaccine appear to be a little less potent against the new variant, named B.1.351, than the one the vaccine was developed for. So researchers were perhaps even more relieved to hear the company will start development of booster shots tailored to B.1.351 and other variants.
“These are exactly the steps that I hoped to see,” says virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center. “It may well not be necessary to have a vaccine update in the fall, but taking these steps now is the right course of action.” Other vaccinemakers are also contemplating updates.
Scientists have grown increasingly concerned that new coronavirus variants may worsen the pandemic. B.1.1.7, first detected in England and now spreading globally, has been shown to be more transmissible; on 22 January, the U.K. government said it may be deadlier as well. B.1.351 and a very similar variant named P.1 that originated in Brazil’s Amazonas state are suspected of evading immunity in people who were vaccinated or previously infected.
Now, researchers from Moderna and the Vaccine Research Center at the U.S. National Institutes of Health have tested the potency of antibodies from eight people who had received the company’s vaccine against a retrovirus modified to express the mutated spike proteins of B.1.351 and B.1.1.7. In a preprint, they report that antibodies neutralized the virus in both cases. But for B.1.351, the levels needed were six times higher than for virus expressing the original protein.
A similar study by virologist David Ho of Columbia University, under review at Nature and posted as a preprint on bioRxiv, found that the serum of 22 people vaccinated with Moderna’s vaccine or a similar one from Pfizer was six to nine times less potent against B.1.351, and serum from 20 previously infected people was 11 to 33 times less potent. Researchers in South Africa, meanwhile, have found that antibodies from six recovered patients were six to 200 times less effective at neutralizing B.1.351.
Such drops sound alarming, but the vaccines produced by Pfizer and Moderna trigger very high levels of antibodies, which likely compensates for the decline in potency, says Florian Krammer, a vaccine researcher at the Icahn School of Medicine at Mount Sinai. Besides, antibodies are only one part of the immune response; the vaccines also trigger T cells. Krammer is “quite optimistic” that both vaccines will still protect against B.1.351 and P.1. “However, this is worrisome for vaccines that are not as potent in inducing neutralizing antibodies as the two mRNA [messenger RNA] vaccines.”
Others agree the results don’t spell doom yet. “Given the high starting point, it’s conceivable [vaccine efficacy] could drop only slightly,” Bedford says. Immunity is not binary, adds Jeremy Farrar, head of the Wellcome Trust: “It doesn’t suddenly turn on and turn off.” A drop in antibody potency could have more subtle effects, such as immunity waning a bit faster, he says. The results with sera from recovered patients also suggest the risk of reinfection with COVID-19 may be rising, especially for people who produced low levels of antibodies during their first encounter with the virus, says Stephen Goldstein, a virologist at the University of Utah. “Most of these people I expect to still have good protection from serious disease. It’s on a spectrum, though.”
It may well not be necessary to have a vaccine update in the fall, but taking these steps now is the right course of action.
Moderna says it will start phase I trials of two booster strategies: a third dose of its current vaccine, or of a slightly different one in which the mRNA has been tweaked to incorporate B.1.351’s mutations. They may be given to volunteers 6 to 12 months after the initial immunization, Moderna Chief Medical Officer Tal Zaks said in a call with investors. Pfizer, in an email to Science, wrote that it, too, is “laying the groundwork to respond quickly if a future variant of SARS-CoV-2 is unresponsive to existing vaccines.” Novavax, which is in late-stage trials with a vaccine based the spike protein, says it is “testing sera against the new strains.”
Georgetown University virologist Angela Rasmussen says it’s “very wise” to start to prepare boosters now. “It’s also wise to begin thinking about how they will be distributed,” she adds. “For example, will they be allocated to regions with evidence that B.1.351 is circulating?” Regulators still need to spell out what trials they would require for updated vaccines. At a press conference on Monday, World Health Organization official Bruce Aylward said work to define a regulatory pathway was “kicking off right now.”
Scientists also need to agree on faster ways to address any concerns about immune escape variants, says Farrar, and standardize the way they test antibodies’ potency: “We need harmonization of the assays, so we can compare the results and it doesn’t matter which lab you’re in.” Animal experiments need to be coordinated as well. Vincent Munster, a virologist at the U.S. National Institute of Allergy and Infectious Diseases, says he has already vaccinated hamsters and will challenge them with virus variants in the next couple of weeks. “These studies take a lot of coordination and we are discussing the need for a more planned approach to prepare for other novel variants emerging,” Munster says.
The most timely answers on B.1.351 may come from humans, however. Efficacy trials of several vaccines, including the Pfizer one, are ongoing in South Africa; Tulio de Oliveira, a virologist at the University of KwaZulu-Natal, says researchers are now sequencing the virus from 150 study participants who became infected. “We’re going have the results in 36 hours,” he says. But only after the trial is unblinded next week will researchers know how many of these infections occurred in people who received the vaccine instead of a placebo.
Ho’s paper also sheds some light on how B.1.351 escapes the immune response. The team produced retroviruses with spike proteins incorporating each of B.1.351’s nine mutations separately, as well as all at once. A mutation named E484K accounted for much of the effect, they found. “E484K is really the bad boy here,” Goldstein says. Brazil’s P.1 variant has the same mutation, which might be a sign that the virus has few other tricks to evade immunity, he says: “The virus has a lot of room to evolve but not infinite room. We may have come upon one of the worst possible mutations already.”
But other researchers say the plethora of recent changes is a warning sign that the coronavirus may have more surprises in store—and that the world needs to administer existing vaccines as fast as possible. “I think we need to stop the virus from replicating however we can,” Ho says. “Otherwise, it will keep accumulating more mutations.”
Gabriel Chodick, PhD1,2 *, Lilac Tene, MSc 1
, Tal Patalon, MD1
, Sivan Gazit, MD1
, Amir Ben
Tov, MD 1
, Dani Cohen #
, PhD 2
, Khitam Muhsen, PhD# 2
doi: https://doi.org/10.1101/2021.01.27.21250612
Research in context
Evidence before this study
We searched PubMed for follow-up studies regarding the effectiveness of BNT162b2 mRNA
Covid-19 Vaccine without any language restrictions. The search terms were (BNT162b2 OR
mRNA Covid-19 Vaccine) AND (effectiveness OR real-world OR phase IV) until Jan 15,
2021. We found no relevant observational studies among humans. We also assessed Phase II
and Phase III clinical trials with BNT162b2 mRNA vaccine.
Added value of this study
To our knowledge, this is the first and largest phase IV study on the effectiveness of the
BNT162b2 mRNA COVID-19 vaccine in real-world settings. Our findings showed that the
first dose of the vaccine is associated with an approximately 51% reduction in the incidence of
PCR-confirmed SARS-CoV-2 infections at 13 to 24 days after immunization compared to the
rate during the first 12 days. Similar levels of effectiveness were found across age groups, sex,
as well as among individuals residing in Arab or ultra-orthodox Jewish communities that
display an increased COVID-19 risk.
Implications of all the available evidence
The study results indicate that in real life the first dose of the new BNT162b2 mRNA COVID19 vaccine confers around 50% protection against overall SARS-CoV-2 infections
(symptomatic or asymptomatic). Together our findings and the 95% efficacy shown in the
phase III trial, suggest that the BNT162b2 vaccine should be administered in two doses to
achieve maximum protection and impact in terms of disease burden reduction and possibly
reducing SARS-CoV-2 transmission. COVID-19 vaccines should be urgently deployed
globally.
Abstract
Background
BNT162b2 vaccines showed high efficacy against COVID-19 in a randomised controlled
phase-III trial. A vaccine effectiveness evaluation in real life settings is urgently needed,
especially given the global disease surge. Hence, we assessed the short-term effectiveness of
the first dose of BNT162b2-vaccine against SARS-CoV-2 infection. Given the BNT162b2
Phase-III results, we hypothesized that the cumulative incidence of SARS-CoV-2 infection
among vaccinees will decline after 12 days following immunization compared to the incidence
during the preceding days.
Methods
We conducted a retrospective cohort study using data from 2·6 million-member state-mandated
health provider in Israel. Study population consisted of all members aged 16 or above years
who were vaccinated with BNT162b2-vaccine between December/19/2020 and
January/15/2021. We collected information regarding medical history and positive SARSCoV-2 polymerase chain reaction test from days after first dose to January/17/2021. Daily and
cumulative infection rates in days 13-24 were compared to days 1-12 after first dose using
Kaplan-Meier survival analysis and generalized linear models.
Findings
Data of 503,875 individuals (mean age 59·7 years SD=14·7, 47·8% males) were analysed, of
whom 351,897 had 13-24 days of follow-up. The cumulative incidence of SARS-CoV-2
infection was 0·57% (n=2484) during days 1-12 and 0·27% (n=614) in days 13-24. A 51·4%
relative risk reduction (RRR) was calculated in weighted-average daily incidence of SARSCoV-2 infection from 43·41-per-100,000(SE=12·07) in days 1-12 to 21·08-per100,000(SE=6·16) in days 13-24 following immunization. The decrement in incidence was
evident from day 18 after first dose. Similar RRRs were calculated in individuals aged 60 or above (44.5%), younger individuals (50.2%), females (50.0%) and males (52.1%). Findings
were similar in sub-populations and patients with various comorbidities.
Conclusions
We demonstrated an effectiveness of 51% of BNT162b2 vaccine against SARS-CoV-2
infection 13-24 days after immunization with the first dose. Immunization with the second dose
should be continued to attain the anticipated protection.
Not so long ago, positive vaccine news provided the antidote to whatever concern might be ailing the stock market, whether it be growth concerns, geopolitical turmoil, or rising virus cases. Strangely enough, the crazy trading action in heavily shorted names like GameStop (GME) and AMC Entertainment (AMC) turned out to be the kryptonite to this formerly reliable crutch.
While the broader market sinks lower as investors weigh the potential implications of the short-squeeze mania, shares of Novavax (NVAX) are rocketing higher after reporting efficacy data for its COVID-19 vaccine, NVX-CoV2373, after the close last night.
With an overall efficacy rate of 89.3%, the vaccine met the primary endpoint, setting the stage for a likely emergency use authorization filing in the near future.
The massive gains in the stock seem shocking given that vaccines from Pfizer (PFE) and Moderna (MRNA), both of which are already available on an emergency use basis, achieved higher efficacy rates. Specifically, those vaccines are reported to be ~95% effective against contracting the virus.
However, there are a couple important factors that distinguish NVAX's vaccine from the others.
NVAX disclosed that its vaccine offered 60% protection against the more concerning South African variant of the virus. That is far lower than 95.6% efficacy rate versus the original strain, but it may be strong enough to significantly slow the spread of the more dangerous variant.
This is especially important because it's already known that the vaccines from PFE and MRNA are not as effective against the South African strain. In fact, MRNA is currently working on a booster shot to guard against the new variant because its uncertain how long the current shot will provide any protection.
NVAX's vaccine is seen as more practical and convenient because it's a single dose rather than a two-dose regiment, like PFE's and MRNA's. Also, since NVAX used a more traditional method to create the vaccine, it can transport doses at normal refrigeration temperatures instead of the extreme cold temperatures required for messenger RNA-based vaccines.
The simpler logistics should allow more people to get the vaccine quicker.
In the weeks leading up to today's data release, NVAX secured deals with various governments to supply its vaccine, including Canada's (up to 76 mln doses), Australia's (51 mln doses), and the EU (up to 200 mln doses). With major manufacturing agreements in place, including with the Serum Institute of India, the company is positioned to immediately begin mass production, assuming the vaccine gains regulatory approval.
Today's launch higher adds to NVAX's breathtaking gains over the past year. With the stock up an astounding ~3,000% yr/yr, it would seem that the promising vaccine news is priced in at this point. In this unusual trading environment, though, nothing can be completely dismissed, including another sharp move higher when and if NVAX's vaccine receives approval.
Brazil will receive between 10 million and 14 million doses of AstraZeneca's coronavirus vaccine starting in mid February through the World Health Organization’s COVAX program, the health ministry said on Saturday.
Brazil has had 58,462 new confirmed cases of the novel coronavirus reported in the past 24 hours, and 1,279 deaths from COVID-19, the ministry said.
The South American country has now registered 9,176,975 cases since the pandemic began, while the official death toll has risen to 223,945, according to ministry data, in the world's third worst outbreak outside the United States and India and its second-deadliest.
The health ministry said it had received a letter from the WHO about the delivery of the vaccine, which AstraZeneca developed in partnership with Oxford University.
On Friday, Brazilian health regulator Anvisa said that AstraZeneca had applied for full regulatory approval, a positive note for the country’s difficult vaccine rollout.
The submission, the first of its kind in Brazil, was made by the federally funded Fiocruz Institute, which will manufacture the British vaccine locally.
