Pfizer and its German partner, BioNTech, fired back at Moderna on Monday in a patent lawsuit over their rival Covid-19 vaccines, seeking dismissal of the
lawsuit in Boston federal court and an order that Moderna's patents are invalid and not infringed.
Moderna first sued Pfizer in August, accusing the company of violating its rights in three patents related to innovations that Cambridge, Massachusetts-based Moderna
said it pioneered before the Covid-19 pandemic.
Moderna has also filed a related lawsuit against Pfizer and BioNTech in Germany. All three companies are also embroiled in US patent disputes with other companies
over the vaccines.
A Pfizer spokesperson said the company and BioNTech are confident in their intellectual property and will "vigorously defend" against Moderna's claims.
Moderna did not immediately respond to a request for comment on the Monday filing.
Moderna has joined one of the UK's leading pharmaceutical industry body, Association of the British Pharmaceutical Industry (ABPI) to expand its footprint and
investment in the UK.
The biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines will strengthen its footprint with the new state-of-the-art vaccine research,
development and manufacturing facility in the UK. It will create valuable new jobs and build on the strength of the UK's life sciences ecosystem.
The company is best known for their work during the COVID-19 pandemic and are now developing a range of mRNA-based vaccines for a number of conditions.
The ABPI represents companies of all sizes who invest in discovering the medicines of the future, including some of the world's largest, most innovative, and most
successful pharmaceutical firms.
Darius Hughes, UK General Manager, Moderna, said: "We are delighted to join the ABPI - this alliance is an important part of our long-term commitment to the UK and
supports the wider significant investments in manufacturing, research and development we are making in this country.
US biotech firm Moderna will build a new research and manufacturing centre in Britain to develop vaccines against new Covid-19 variants, other respiratory
illnesses and help improve readiness for any future pandemics.
The facility is expected to start producing shots in 2025 and Britain has made a commitment to buy Moderna's vaccines for the next decade under the agreement.
Moderna's Covid-19 vaccines, which use messenger RNA (mRNA) technology, were among those deployed in Britain to tackle the crisis and enable prime minister Boris
Johnson to reopen the economy from stringent lockdowns.
Moderna chief executive Stephane Bancel said the priority was to develop a shot combining refreshed boosters against Covid, flu and Respiratory Syncytial Virus (RSV).
"By building a plant in the UK, we are also providing the UK Government - which has a long term partnership with us, with this agreement - with the ability to be
pandemic ready," Bancel said on Wednesday.
Existing Covid-19 inoculations will struggle against the fast-spreading Omicron variant, the head of vaccine manufacturer Moderna warned on Tuesday (November 30), as countries ramp up vaccination programmes and impose further restrictions in an effort to curb growing concern.
First reported to the World Health Organization in South Africa less than a week ago, the new strain has rapidly spread from Africa to the Pacific, and from Europe
to North America as dozens of countries have announced travel restrictions.
While no deaths have yet been reported from Omicron, and it could take weeks to know how infectious and how resistant the strain may prove to vaccines, its emergence underscores how besieged the world remains by Covid-19, nearly two years after the first cases were recorded.
Stephane Bancel, the head of US vaccine manufacturer Moderna, told the Financial Times in an interview published today that data would be available on the effectiveness of vaccines in the two weeks' time, but that scientists were pessimistic.
The Pharmacists' Defence Association (PDA) has urged pharmacists working in Covid-19 vaccination role to report any concerns about the needles and syringes
supplied with the Moderna Spikevax Bivalent vaccine.
The association has heard reports of bending when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses, needles falling out during manipulation
and appearing to be bent even before removal from the packaging.
PDA has advised its members who are working in a Covid-19 vaccination role "to report any concerns via the Yellow Card medical device reporting system, and to keep up
to date with NHS clinical updates for ongoing information and guidance."
Current advice from the NHS includes sharing of video and poster resources (available on FutureNHS) which have been produced by the supplier to support the
introduction of the new administration needles and syringes for Spikevax Bivalent.
This is following a switch from BD Flu+ 23G x 25mm 1ml syringe combined needle and syringe (CNS) to the Owen Mumford Unifine Safety Retractable Needle 25G x 25mm &
1ml Syringe.
Covid-19 vaccines made by Pfizer and Moderna that use mRNA technology provide the biggest boost to antibody levels when given 10-12 weeks after the second dose, a new study has found.
The "COV-Boost" study was cited by UK officials when they announced that Pfizer and Moderna were preferred for use in the country's booster campaign, but the data has only been made publicly available now.
The study found that six out of the seven boosters examined enhanced immunity after initial vaccination with Pfizer-BioNTech's vaccine, while all seven increased immunity when given after two doses of AstraZeneca's vaccine.
"A third dose will be effective for many of the vaccines we've tested and in many different combinations," Professor Saul Faust, an immunologist at the University of Southampton and the trial's lead, told the media.
Covid-19 vaccine makers are shifting gears and planning for a smaller, more competitive booster shot market after delivering as many doses as fast as they
could over the last 18 months.
Executives at the biggest Covid vaccine makers including Pfizer and Moderna said they believe most people who wanted to get vaccinated against Covid have already done so - more than five billion people worldwide.
In the coming year, most Covid vaccinations will be booster shots, or first inoculations for children, which are still gaining regulatory approvals around the world, they said.
Pfizer, which makes its shot with Germany's BioNTech and Moderna still see a major role for themselves in the vaccine market even as overall demand declines.
Upstart US vaccine maker Novavax and Germany's CureVac, which is working with GlaxoSmithKline, are developing vaccines they hope to target at the booster market.
The roles of AstraZeneca and Johnson & Johnson, whose shots have been less popular or effective, are expected to decline in this market.
American global healthcare company, Viatris, has launched a new rapid self-test for qualitative detection of antibodies developed after Covid-19 vaccinations.
The firm is going to market the Covid-19 Neutralising IgG Serological self-test, manufactured by PRIMA Lab SA, in the UK market, which would check presence of
neutralising antibodies after vaccination.
The presence of antibodies indicates that a person has had an immune response to the Covid-19 vaccine, and not that protective immunity has been acquired. The self-test that can be performed easily at home with a small blood sample, delivers results in just 10 minutes and has a recommended retail price of sub £20.
After two doses of the Covid-19 vaccine, the self-test has shown a seroconversion rate of 98.3 per cent for the Pfizer vaccine, 98.5 per cent for the AstraZeneca vaccine and 95.2 per cent for the Moderna vaccine.
It recommended that the test be performed at least 14 days after completing the vaccination cycle.
The University of Oxford on Tuesday said there was no evidence that vaccines would not prevent severe disease from Omicron, but that it was ready to rapidly develop an updated version of its vaccine developed with AstraZeneca if necessary.
Earlier on Tuesday, the head of drugmaker Moderna said that Covid-19 shots were unlikely to be as effective against the variant, jolting global markets.
The University of Oxford said that there was limited data on Omicron so far, and that it would carefully evaluate the impact of the variant on its shot, echoing an AstraZeneca statement last week.
"Despite the appearance of new variants over the past year, vaccines have continued to provide very high levels of protection against severe disease and there is no evidence so far that Omicron is any different," it said in a statement.
Even as the UK agrees deals for 14 million additional vaccine doses from Moderna and Pfizer, the Royal Pharmaceutical Society has renewed its calls for community pharmacies in England to play an increased role in delivering booster jabs for Covid-19.
"Pharmacists and pharmacy teams across the health service in England have been crucial to the success of the flu and Covids-19 vaccination programmes from the outset," said Thorrun Govind, chair of the RPS in England, who has been making a case on national television for an increased role of the profession.
She added: "They continue to go above and beyond to support patient care, engaging with local communities and helping to overcome vaccine hesitancy.
"They've already done so much this year to look after patients in really difficult circumstances, but many will be ready to rise to the challenge of this new national effort."
Britain has become the first country to approve a Codiv-19 vaccine that targets both the original and Omicron variant of the virus.
Medicines regulator MHRA approved the so-called bivalent vaccine made by US drug company Moderna as a booster for adults.
The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original
2020 virus, it said.
The MHRA also cited an exploratory analysis in which the shot was also found to generate a good immune response against the currently dominant Omicron offshoots BA.4
and BA.5.
"The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA chief executive
June Raine said in a statement.
"What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve."
An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights
for Covid-19 interventions between the pharmaceutical industry and developing nations endures.
At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries
when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected.
In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry
collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA).
The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved
in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck.
The declaration is not legally binding.
However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.
French drugmaker Sanofi said on Monday (June 13) an upgraded version of the Covid-19 vaccine candidate it is developing with GSK showed potential in two
trials to protect against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot.
While the two companies' first experimental Covid shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that
is moulded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations.
Sanofi said this new vaccine candidate was shown to significantly boost antibody levels against a number of variants of concern, when given to trial participants
who had an initial course of mRNA vaccines, a type made by BioNTech-Pfizer and Moderna.
In a separate trial conducted by a French hospitals network, Sanofi's Beta-adapted booster shot triggered a higher immune response than Sanofi's first-generation
shot or Pfizer-BioNTech's established vaccine in previously vaccinated volunteers.
Pharmaceutical giant GlaxoSmithKline aims to get its respiratory syncytial virus (RSV) vaccine to regulators for review later this year, after interim data
showed the vaccine was effective in a keenly-watched late-stage study involving older adults.
RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to
develop a vaccine since the virus was first discovered in 1956.
Companies including Pfizer, J&J, Sanofi, Moderna and AstraZeneca are also racing to get an RSV therapy or vaccine approved.
The latest GSK trial is the first to show statistically significant efficacy for RSV in adults aged 60 years and older, the British drugmaker said of the ongoing
study on Friday (June 10).
If approved, the RSV vaccine is expected to generate billions for GSK, which is already the world's biggest vaccine maker by sales but has faced pressure from
activist investors such as Elliott Management who have urged the London-based company to shore up its drug pipeline.
Covid-19 vaccine maker Novavax on Wednesday said it expects revenue this year to be flat or lower as it works to improve its commercial performance and
pick up market share from much larger rivals, Pfizer and Moderna.
The company posted a larger-than-expected fourth-quarter loss as revenue lagged analysts' estimates.
Chief executive John Jacobs said Novavax claimed just a low-single-digit percentage market share in the US during the most recent vaccination campaign, as demand
for Covid vaccines was smaller than hoped and the company got its protein-based shot to market later than its messenger RNA-based rivals.
"We were disappointed with that US performance," Jacobs said in an interview.
He said the company's sales force was not targeted enough toward retail pharmacy chains, and that its 5-dose vials were not as convenient for use as rivals'
pre-filled syringes.