7 May 2021

• Okonjo-Iweala, Director General of the World Trade Organization, says she will press the 164 member countries to reach an agreement on the waiver petition by 3 December. Source

• EU expressed willingness to discuss the intellectual property waiver after the US supported it. But in Germany – home to Pfizer’s coronavirus vaccine partner, BioNTech, a spokesperson for Germany’s Chancellor, Angela Merkel, warned that it would hamper development of new pharmaceutical products.  Source

• Spain supports the TRIPS waiver, saying an in informal policy paper that “Intellectual property cannot be an obstacle to ending Covid-19 and to ensuring equitable and universal access to vaccines,” and that consensus must be “urgently found on the proposal for a temporary waiver.” Source

• Pfizer CEO Albert Bourla posts a letter to Pfizer staff describing  the company’s access strategy for low-and middle-income countries (tiered pricing); it states that “ …I reached out to many heads of middle/low-income countries by letter, phone and even text to urge them to reserve doses because the supply was limited. However, most of them decided to place orders with other vaccine makers either because mRNA technology was untested at that time or because they were offered local production options. Some didn’t even approve our vaccine.” The letter says that 40 percent of the 2.7 billion doses of coronavirus vaccine produced in 2021 will go to low-and middle-income countries.

• Bourla says that the intellectual property waiver  “…threatens to disrupt the flow of raw materials. It will unleash a scramble for the critical inputs we require in order to make a safe and effective vaccine. Entities with little or no experience in manufacturing vaccines are likely to chase the very raw materials we require to scale our production, putting the safety and security of all at risk. I worry that waiving of patent protection will disincentivize anyone else from taking a big risk,” noting that Pfizer has already spent two billion dollars to develop its coronavirus vaccine, and is investing more into COVID-19 research.  Source

• After receiving the Sinopharm coronavirus vaccine on television, Philippine President Rodrigo Duterte was harshly criticized for choosing a vaccine that had not been approved by the national regulatory agency – instead of using the SinoVac vaccine, which is already approved for emergency use in the country. President Duterte asked China to take back the 1,000 doses it donated and asked the ambassador to “….just give us SinoVac, which is being used by everyone else.” Source

• WHO approves the Sinopharm coronavirus vaccine developed by the Beijing Institute of Biological Products for emergency use, although very little information on it has entered the public domain, and  its effectiveness against currently circulating variants is not known. Source 

• The EMA pharmacovigilance committee met to discuss safety signals related to coronavirus vaccines. It will continue to monitor rare blood clots and low platelets among people who got vaccines from Pfizer/BioNTech and Moderna. The committee  has asked AstraZeneca to provide more detailed information on  cases of Guillain-Barre syndrome among vaccine recipients, and has asked Pfizer for more information on cases myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) following vaccination, although it does not currently think the vaccine is causing these side effects. Moderna is also being asked to monitor similar cases and provide details.

The committee conducted several reviews, including on unusual blood clots and low platelets from the J & J vaccine, concluding that the benefits  outweighed the risk and has changed the product information to recommend that people diagnosed with thrombocytopenia within three weeks of vaccination should be actively investigated for signs of thrombosis, and that  people who present with thromboembolism within three weeks of vaccination should be evaluated for thrombocytopenia. Thrombosis with thrombocytopenia syndrome will be added as an ‘important identified risk’ in the vaccine’s  risk management plan and Janssen will provide a plan to further study possible underlying mechanisms for these very rare events.

The committee also reviewed facial swelling in persons injected with dermal fillers among recipients of the Pfizer/BioNTech vaccine (the committee decided there is “…at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers” and this information will now be included in the summary of product characteristics and the patient information leaflet). Source

• The pressure to implement a nationwide lockdown in India increases, as the daily total of coronavirus infections reaches 414,188 – a new record. Source

• Pfizer and BioNTech become the first to apply for full FDA approval of their coronavirus vaccine, which would expand the market by making it easier for employers, schools and government agencies – including the military – to mandate vaccination and allow direct-to-consumer advertising. Source

• Problems at a US vaccine production facility have had an impact on coronavirus vaccination campaigns in several countries. The US FDA has not cleared 70 million doses of the J & J coronavirus vaccine produced at the Emergent Biosolutions plant in Baltimore, where production was halted due to numerous problems with quality. Millions of these potentially contaminated vaccines have been sent to the EU, as well as Canada and South Africa, where regulators are working to determine whether they are safe to use – which is  their vaccination campaigns. In the EU, a pair of batches – comprising 2.5 million doses- remain on hold. Health Canada is working with the US FDA and J & J;  it will only release the vaccines when  it is “….satisfied that they meet the Department’s high standards for quality, safety and efficacy.” In South Africa, the vaccines need to undergo “a protracted safety verification process with international regulatory agencies,” the nation’s health minister said, as “…a precautionary measure following the adverse findings.” The doses could be cleared by mid-May.  Source

• Britain’s Joint Committee on Vaccination and Immunization announces that adults under age 40 should be offered alternatives to the AstraZeneca coronavirus vaccine, over concerns about and since they are at lower risk for severe COVID-19. Source

• The UK  continues to monitor emergence of coronavirus variants as cases of  B.1.617, the variant first identified in India, have doubled in just a week (from 202 to 520), and it is considered as transmissible as B.1.1.7. Source

• Russia’s Ministry of Health announces that a single dose of the Sputnik V coronavirus vaccine – referred to as “Sputnik Lite” provides sufficient protection, which could accelerate the country’s vaccination campaign. Source

• Germany announced that it will administer the AstraZeneca coronavirus vaccine to people who are 18 years and older, and that a second dose can be given sooner; the country expects to vaccinate children ages 12 and over in August. Source

• Campaign rallies and elections in India may have contributed to coronavirus’s spread into rural areas, such as West Bengal, which has a 31 percent positivity rate and poor healthcare infrastructure  – and where Prime Minister Narenda Modi’s party was defeated in last week’s elections. Dr. Thekkekara Jacob John, a senior virologist in Tamil Nadu, said “There is a clear pattern here: States that went through elections and where large rallies were held are witnessing a huge rise in cases.” Source

• The US CDC changes its public guidance to acknowledge airborne transmission of COVID-19, saying “People release respiratory fluids during exhalation (e.g., quiet breathing, speaking, singing, exercise, coughing, sneezing) in the form of droplets across a spectrum of sizes. These droplets carry virus and transmit infection. The largest droplets settle out of the air rapidly, within seconds to minutes.The smallest very fine droplets, and aerosol particles formed when these fine droplets rapidly dry, are small enough that they can remain suspended in the air for minutes to hours. With increasing distance from the source, the role of inhalation likewise increases. Although infections through inhalation at distances greater than six feet from an infectious source are less likely than at closer distances, the phenomenon has been repeatedly documented under certain preventable circumstances.10-21 These transmission events have involved the presence of an infectious person exhaling virus indoors for an extended time (more than 15 minutes and in some cases hours) leading to virus concentrations in the air space sufficient to transmit infections to people more than 6 feet away, and in some cases to people who have passed through that space soon after the infectious person left.” Source

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