Shares of Moderna and BioNTech stocks fell their most in 17 months on Wednesday while those of Pfizer slid as well after reports emerged that Europe’s drug regulator was studying for new side effects from COVID-19 vaccinations.
Moderna slumped 17.6 percent to $376.49 by 2:00 PM in New York (18:00 GMT). BioNTech also fell almost 18 percent to $341.88. It was the sharpest daily loss for both companies dating back to March 2020, at the cusp of the coronavirus pandemic. Pfizer’s stock dipped by 4 percent to $46.38.
The slide in the shares of the drugmakers came amid reports that European authorities were reportedly studying three new conditions reported by a small number of people after being vaccinated with mRNA COVID-19 shots made by Moderna and Pfizer-BioNTech
Pfizer, and its German counterpart BioNTech, are the largest suppliers of coronavirus vaccines to Europe.
Just over 43.5 million doses of Moderna's vaccine have been administered in the European Economic Area as of July 29, the EMA said, compared to more than 330 million doses of the BioNTech-Pfizer shot.
The European Medicines Agency (EMA) is studying several possible negative side effects related to Pfizer/BioNtech’s Comirnaty and Moderna’s Spikevax mRNA coronavirus vaccines.
According to the EMA's safety updates, the Pharmacovigilance Risk Assessment Committee has begun the assessment of erythema multiforme, glomerulonephritis, and nephrotic syndrome to determine if they could potentially be caused by the use of Comirnaty and Spikevax.
Erythema multiforme is a skin reaction that is triggered by an infection or some medicines. It manifests in target lesions, which can affect mucous membranes in the human body.
Glomerulonephritis refers to a number of diseases characterized by inflammation of the glomeruli, tiny vessels inside the kidneys which filter blood. Nephrotic syndrome is a kidney disorder that causes the kidneys to pass large amounts of protein into one's urine.
The EMA has so far approved four COVID-19 vaccines — produced by Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson — for use within the European Union.
The United Kingdom is set to announce a deal with Pfizer for 35 million COVID-19 vaccine doses worth 1 billion pounds ($1.4 billion), a fifth costlier than before, UK media said.
The Times newspaper reported on Wednesday that the order would be announced this week. The vaccines are due to arrive in time for the UK's second booster campaign next fall.
The Times reports the US drugmaker raised the price to £22 a dose from £18 due to global demand. Pfizer said it and its German partner BioNTech used a "tiered pricing formula" based on volumes and delivery rates.
The British government reportedly decided to book extra doses over fears it would have to bring back lockdowns if it were to run out of shots in 2022. Concerns grew after the European Union placed a bulk order for 900 million Pfizer shots.
Health Secretary Sajid Javid said the UK would begin the booster campaign in September. It will use the Pfizer vaccine instead of AstraZeneca after studies suggested that a mix-and-match approach gave a good immune response.
Plans for the use of booster doses drew criticism from the World Heath Organization, which called for a halt on COVID-19 boosters in order to achieve better access to vaccines globally. The WHO chief said last week that he could not accept having richer countries use most of the global vaccine supply while the majority of the world remained unvaccinated.
The European Medicines Agency (EMA) added Guillain-Barre syndrome as a very rare side effect of Johnson & Johnson's Jenssen vaccine, based on their latest safety update on authorized COVID-19 vaccines in the European Union on Wednesday.
"Guillain-Barré syndrome has been added to the product information as a very rare side effect. PRAC recommended updating the product information to include immune thrombocytopenia, dizziness and tinnitus as side effects," the agency said.
At the same time, no further safety updates were given for the other three vaccines authorized by and used in the European Union — BioNtech’s Comirnaty, Moderna’s Spikevax and AstraZeneca’s Vaxzervia.
The agency was investigating a possible connection between Johnson & Johnson's vaccine and Guillain-Barré Syndrome, which is an autoimmune disorder that damages the nerves. In July, EMA issued an advisory recommending that Guillain-Barre Syndrome be added to the warning label vaccine as, at the time, there were fifteen cases registered following vaccination with Johnson & Johnson's vaccine.
France will start COVID-19 revaccination for vulnerable groups of people from mid-September, government spokesman Gabriel Attal said on Wednesday.
"The President of the Republic decided to organize a revaccination campaign for at-risk groups. It will be established by the National Authority for Health … It will be possible to sign up [to the vaccination] from the end of August - the beginning of September, and the campaign will begin in mid-September," Attal said after a meeting of the Council of Ministers.
Earlier in the day, President Emmanuel Macron described the current COVID-19 situation in France as “more than difficult.” The daily numbers have been mounting since mid-July, with the most recent figure exceeding 30,000.
To date, France has administered a total of nearly 80 million doses of COVID-19 vaccines and registered more than 6.4 million coronavirus infections and over 112,000 related fatalities.
The European Union Agency for Law Enforcement Cooperation, known as Europol, announced on Wednesday that an online scam involving the sale of protective materials against COVID-19, such as facemasks, has been uncovered as 23 suspects are charged with business email fraud.
"On 10 August, 23 suspects were charged as a result of a series of raids carried out simultaneously in the Netherlands, Romania and Ireland. In total, 34 places were searched. These criminals are believed to have defrauded companies in at least 20 countries of approximately €1 million [$1.2 million]," Europol said in a press release.
The gang is comprised of Africans living in Europe who put up fake websites using names similar to legitimate wholesale companies. They thus posed as legitimate companies and deceived their victims — mostly European and Asian companies – into making orders with them, asking for advance payments for the products to be delivered. Ordered products were never delivered, and the proceeds of the fraudulent sales were wired through Romanian banks before being withdrawn at ATMs.
The operation was carried out under the framework of EMPACT in collaboration with law enforcement from Romania, Ireland, the Netherlands, and the European cybercrime center.
EMPACT, an intelligence-led EU initiative, was set up to tackle the main criminal threats the European Union is facing. The initiative was first undertaken from 2012-2013, after which there were two four-year cycles between 2014-2017 and 2018-2021. In March 2021, the Council adopted conclusions on the permanent continuation of EMPACT as a crucial instrument for cooperation against major organized international crime.
A Greek health authority reported a daily increase of 4,181 new coronavirus cases on Tuesday, which comes close to the March record of 4,340.
"The new laboratory-confirmed cases of the virus, recorded within the last 24 hours are 4,181, of which 11 were found in tests performed in the country's entry points," the National Public Health Organization said in its latest report.
Greece has seen an increase in new infections in the last few weeks with the number of cases rising noticeably in the country's most visited summer resorts. The popular resort destination of Heraklion in Crete is on a seven-day nighttime curfew, taking effect on Wednesday.
The European Centre for Disease Prevention and Control has been watching these developments as well. In July, it marked the South Aegean Islands dark red on its COVID-19 map, which means that all but essential travel to the region is discouraged. This geographical area includes Greece's most popular summer destinations like Santorini, Mykonos, Paros, Rhodes, and Crete.
The World Health Organization (WHO) declined on Wednesday to name a deadline for the assessment of Russia's Sputnik V vaccine against COVID-19, saying legal proceedings were in progress.
The Russian Direct Investment Fund, which markets the shot abroad, applied for its Emergency Use Listing with the WHO in October. The UN agency's authorization will allow Sputnik V to be rolled out globally.
"The process is still ongoing. We have some legal proceedings ongoing at the moment and we don't have a date to finalize the assessment," Mariangela Simao, WHO's assistant director-general, told a press briefing.
WHO said in June that it had conducted nine inspections of Sputnik V clinical trial and manufacturing sites, some of them jointly with the European Medicines Agency. The EU drug regulator began its own rolling review of the vaccine in March.
The Spanish Agency of Medicines and Medical Devices (AEMPS) authorized clinical trials for the PHH-1V coronavirus vaccine of the Hipra pharmaceutical company, the Ministry of Health said on Wednesday.
This is the first time a COVID-19 vaccine produced in Spain will be tested on humans.
“The AEMPS has authorized the clinical trial of the PHH-1V vaccine against COVID-19 of the Hipra company,” the Health Ministry said.
The vaccine is similar to those made by the United States' Novavax and French Sanofi/GSK, which are being evaluated by the European Medicines Agency, but uses different types of protein.
"This vaccine is based on two structurally similar recombinant proteins, one of which corresponds to the Alpha variant, and the other to the Beta variant, which are combined to form a unique structure called a dimer, and are accompanied by an adjuvant, which strengthens the immune response," the Ministry of Health explained.
In the first stage, the main task is to identify the safety and tolerability of the vaccine, the secondary goal is to evaluate its immunogenicity and efficacy, the ministry said. The second dose of the vaccine will be administered 21 days after the first one.
The trial will involve several dozen volunteers from various medical centers in the country.
The World Health Organization (WHO) announced on Wednesday that it was launching the next phase of its Solidarity trial to test three new drugs in hospitalized COVID-19 patients.
"The World Health Organization (WHO) has announced the next phase in its Solidarity trial: Solidarity PLUS will enroll hospitalized patients to test three new drugs in hospitalized COVID-19 patients. These therapies - artesunate, imatinib and infliximab – were selected by an independent expert panel for their potential in reducing the risk of death in hospitalized COVID-19 patients," the WHO said.
The drugs in question were donated for the trial by their manufacturers, the statement noted, adding that they are already used against other diseases — artesunate for severe malaria, imatinib for certain cancers, and infliximab for diseases of the immune system such as Crohn’s Disease and rheumatoid arthritis.
"Solidarity PLUS trial for promising drugs will roll out in 52 countries, an unprecedented global collaboration for COVID-19 R&D," the WHO added.
The Solidarity trial was launched last year to assess multiple treatments against the coronavirus at the same time while using a single protocol. It allows new treatments to be added and those ineffective to be dropped throughout the course of the trial.
As part of the trial, four drugs have already been evaluated — remdesivir, hydroxychloroquine, lopinavir and interferon. All of them had little or no effect on hospitalized patients with COVID-19.
The World Health Organization (WHO) expects to have updates on the final assessment of Bharat Covaxin, India’s domestic COVID-19 vaccine, by mid-September, Mariangela Simao, the assistant director-general of the WHO, said on Wednesday.
"I do have good news because we have started the assessment of Bharat Covaxin in July and it's very advanced. We expect that we may have news of a final assessment in the beginning-middle of September," Simao told a press briefing.
The number of new coronavirus infections per day in Japan has hit a new record high, rising above 15,800 fresh cases over the past 24 hours, media reported.
The previous highest rate was confirmed during the Olympic Games in Tokyo on 7 August, standing at 15,753 fresh infections.
As of Wednesday, 4,200 new infections were confirmed in Tokyo, 1,565 in Kanagawa, 1,490 in Osaka, 1,227 in Saitama, and others, with a countrywide total climbing to 15,813 new coronavirus cases, according to the JapanToday media outlet.
The death toll stood at 18, it added. Overall, the total cumulative of coronavirus infections in the country has exceeded 1,7 million, with the death toll standing at over 15,300.
The Japanese government has boosted strict health measures in a number of areas across the country amid a recent surge in COVID-19 cases.
World’s COVID-19 case total may pass 300 million by "early next year" if current trends continue, Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization (WHO), said on Wednesday.
"At the current trajectory, we could pass 300 million reported cases early next year but we can change that," Tedros told a press conference.
The global case tally topped 200 million COVID-19 cases last week, only six months after the "world passed 100 million cases," the WHO chief said.
माननीय सिसोदिया जी,
— Mansukh Mandaviya (@mansukhmandviya) August 11, 2021
26 जुलाई को मेरे मंत्रालय ने दिल्ली सरकार को जो मेल भेजा है, ये रही उसकी कॉपी।
अभी भी देरी नहीं हुई है! 13 अगस्त तक आप डेटा भेज सकते हैं ताकि हम प्रश्न का उत्तर संसद को भेज सकें। अपने अधिकारियों से समीक्षा करके जरूरी डाटा जल्द से जल्द भिजवाने की कृपा करें। https://t.co/EeatjbT2OO pic.twitter.com/ZnyyRsXnQ0
Russia registered 21,571 COVID-19 cases over the past 24 hours, up from 21,378 the day before, taking the overall tally to 6,512,859, the federal response centre said on Wednesday.
"Over the past day, 21,571 COVID-19 cases were confirmed across 85 Russian regions, including 1,740 cases (8.1%) without clinical symptoms," the centre said, adding that the rate of increase stands at 0.33%.
Moscow has the highest number of new cases with 2,076 daily infections, up from 1,639 cases the day before. The Russian capital was followed by St. Petersburg with 1,804 new cases, down from 1,811, and the Moscow region with 1,054 cases, down from 1,309.
The response centre reported 799 new deaths linked to the coronavirus, up from 792 the day before, raising the country's total death toll to 167,241.
In the same 24 hours, 20,067 COVID-19 patients were discharged from hospitals across the country, up from 18,729 the day before, bringing the total to 5,808,777.
