We have new developments in the aftermath of a toxic train derailment in East Palestine, Ohio. The same year, John Young, who was a group president at Pfizer, told investors the company had submitted a corrective and preventative action plan for the facility. Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 3 days after either dose and lasted a median duration of 1 to 2 days. Researchers in the United States have conducted a study showing that the coronavirus disease 2019 (COVID-19) vaccines developed by Pfizer-BioNTech and Moderna generate a coordinated adaptive immune response that is capable of eliciting recall responses to future infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). He added: 'For small, low molecular weight products, the active pharmaceutical ingredient integrity is typically close to 100 per cent. (a) Anterior chest wall treatment plan (Patient 2). You need to speak in English when talking about the vaccine, please and thank you. The comments below have not been moderated. Its what you dont want as a company, he said. Dr. Marty talk about the FDA's approval of a new RSV vaccine for adults and whether or not she agrees on the most likely cause of COVID-19. I do not envy the FDA choices, Unger said, describing a balancing act. While not speaking directly about the Pfizer plant, Fuson said the FDA lacks the resources to do all the inspections we might like it to do.. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. And the UK Medicines and Healthcare products Regulatory Agency has yet to respond to MailOnline's request for comment. "Pfizer-BioNTech and Moderna COVID-19 vaccines establish recall responses to reinfection". Someone, please explain this to those of us that didn't dedicate our lives to science or virology. Reporting is encouraged for other clinically significant adverse events, even if it . Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for emergency use to prevent COVID-19 as: HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA CONTRA EL COVID-19 DE PFIZER-BIONTECH PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN NIOS DE 6 MESES A 4 AOS As soon as pharmaceutical company Pfizer issued a press release on the morning of November 9th indicating that their Covid-19 vaccine candidate appears . And it was Young, now Pfizers chief business officer, who last month told Congress that Pfizer had added production lines at the McPherson site to help meet covid-19 vaccine demands. Cancer Treat Rev. Unable to load your collection due to an error, Unable to load your delegates due to an error. Epub 2022 Oct 19. HHS Vulnerability Disclosure, Help Stereotactic body radiation therapy (SBRT) dose distributions for lung treatments (Patient 1). The honeytrap plot that left father-of-six dead: Moment two women lead victim into his flat to seduce him 'Sonic boom' is heard across central England as 'ground shakes' and houses are rocked. Two years ago, Moderna enlisted Samsung Biologics to produce COVID-19 vaccines. Before sharing sensitive information, make sure you're on a federal government site. COVID-19 Vaccine-Induced Radiation Recall Phenomenon Int J Radiat Oncol Biol Phys. Updated Pfizer-BioNTech COVID-19 vaccine also became available on December 9, 2022 for children aged 6 months-4 years to complete the primary series. Subscribe to KHN's free Morning Briefing. 1959;73:175177. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Revealed: The new '23' number plates the DVLA deems offensive and has banned including EU23 OFF and GO23 HEL. McPhersons management suspended production and rejected batches of finished products after finding mold on equipment in a filling area, according to an FDA inspection report. There are not many proven ways of ensuring long-term survival of the vaccine. Radiother Oncol. Have questions? They help us to know which pages are the most and least popular and see how visitors move around the site. In both cases however, the RRP presented within days of the patient receiving the second dose of vaccine. Comirnaty is a monovalent COVID-19 vaccine that is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. Scientists say mRNA vaccines are cheaper to make and easier to modify in the face of new variants or viruses. Lancet. -, Burris H.A., Hurtig J. COVID-19 vaccine-induced Recurrence of the Radiation Recall Phenomenon in the Laryngeal Mucosa Due to a VEGF Inhibitor. Former FDA investigator Godshalk said an OAI puts the company on notice. According to one of the leaked emails dated November 25, an EMA official said: 'The latest lots indicate that % intact RNA are back at around 70-75 per cent, which leaves us cautiously optimistic that additional data could address the issue.'. Our study highlights a coordinated adaptive immune response where early CD4 T cell responses facilitate the development of the B cell response and substantial expansion of effector CD8 T cells, together capable of contributing to future recall responses, concludes the team. The Pfizer vaccine for the novel coronavirus, SARS-CoV-2, appears to be effective in clinical trials and real-world situations. We appreciate all forms of engagement from our readers and listeners, and welcome your support. (b) Acute skin reaction after COVID-19 vaccination (Patient 1). 'All the topics that emerged during the procedure have been discussed transparently with the agency, in accordance to the normal practices, and all questions have been duly addressed during the review process. All information these cookies collect is aggregated and therefore anonymous. Single-cell analyses also revealed an expansion of activated CD4+ T cells and robust spike-specific polyfunctional CD4 T cell responses following vaccination. analyse site usage and support us in providing free open access scientific content. Regulators in the EU and UK check every batch of the vaccine before allowing them to be used. Lumbar spine treatment planoblique fields (Patient 2). Inside Matt Hancock's 41-hour battle to save his career when photo of 'a snog and heavy petting' with aide 'Arrested at the airport? Find out more information on COVID-19 vaccines and children. Minyvonne Burke. They added: 'Following the initial disclosure of a data breach that occurred at EMA, some documents relating to the EMA's rolling review of the Pfizer/BNT vaccine clinical program have been found on the internet. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Smoking Pot Every Day Linked to Heart Risks, Artificial Sweetener Linked to Heart Risks, FDA Authorizes First At-Home Test for COVID and Flu, New Book: Take Control of Your Heart Disease Risk, MINOCA: The Heart Attack You Didnt See Coming, Health News and Information, Delivered to Your Inbox. The plants manufacturing issues can be traced in FDA reports dated from 2011 to last year. A race against Covid: How Moderna and Pfizer-BioNTech developed vaccines in record time Published Fri, Aug 27 2021 8:00 AM EDT Updated Fri, Aug 27 2021 3:04 PM EDT Meg Tirrell @megtirrell Comirnaty, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. National Library of Medicine The breakthrough jab shown to be 95 per cent effective at blocking Covid-19 was the first vaccine against the virus in the world to seal approval when Britain gave it the green light in December. Copyright 2021 Elsevier Inc. All rights reserved. This is a good review of the findings. The leaks raise questions about the quality of other mRNA vaccines, including Moderna's jab which is already being rolled out in the US and will be shipped to Britain sometime in the coming weeks. The emails were part of more than40 megabytes of classified information from the agency's review that were published on the dark web following the cyber attack. Pfizer says Covid vaccine 100 percent effective in children ages 12 to 15. In 2019, when CEO Albert Bourla took the helm at Pfizer, he told analysts it would be another hard year for U.S. hospitals to get their hands on sterile injectables because of ongoing work at the McPherson plant. FDA says Pfizer's new RSV vaccine for older adults . Several former FDA staffers and industry experts said the ongoing challenges in McPherson highlight how agency officials must balance aggressively going after a companys manufacturing practices with the need to keep the supply of medications flowing to patients. Not all recalls are announced in the media, but all recalls are listed in FDAs weekly Enforcement Reportsexternal icon. Wake up. The McPherson, Kansas, facility, which FDA inspectors wrote is the nations largest manufacturer of sterile injectable controlled substances, has a long, troubled history. To preserve Pfizer's vaccine, it needs to be stored at super-low temperatures of about -70C (-94F) and kept in dark glass vials to shield it from light. We encourage organizations to republish our content, free of charge. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Does a negative COVID-19 test before air travel reduce the spread of COVID-19 transmission during and after travel? It can be republished for free. The agency halted non-urgent foreign and domestic inspections in March 2020 out of concerns for staff safety and has since resumed select visits to domestic plants. Frequencies of activated CD8 T cells were comparable between the vaccinated and convalescent groups. The Pfizer-BioNTech vaccine was the first COVID-19 shot to be authorized for use in the European Union. Makers of the jab warn it only be in transport at normal fridge temperatures for a maximum of six hours, because it's fearedmovement in warmer conditions breaks down the vaccine even quicker. The site is secure. -. One proven method isextremely cold temperatures, which stops all movement and reactions and prevents any form of decomposition of the mRNA. That means the FDA is trusting the company to fix the observations made during the inspections, he said. Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due . John Avellanet, an FDA compliance expert and principal at Cerulean Associates, reviewed the 2020 inspection reports. -, D'Angio G.J., Farber S., Maddock Cl. When a recall is related to a possible safety concern noted by the manufacturer, people who were vaccinated should be aware of their reaction to the vaccine, and talk to their doctor if they have any concerns that they may be having a reaction. COVID-19 vaccines are safe and effective and severe reactions after vaccination are rare. Natural infection and vaccination provide two different pathways to immunity, which studies have previously shown to be characterized by distinct T and B cell responses. In 2019, when CEO Albert Bourla took the helm at Pfizer, he told analysts it would be another hard year for U.S. hospitals to get their hands on sterile injectables because of ongoing work at the McPherson plant. These include the messenger RNA- (mRNA) based vaccines developed by Pfizer (BNT162b2) and Moderna (mRNA-1273). The team from the University of California found that immunization with either Pfizer-BioNTechs BNT162b2 or Modernas mRNA-1273 vaccine-induced enrichment of spike-specific B cells. Almasri M, Bshesh K, Khan W, Mushannen M, Salameh MA, Shafiq A, Vattoth AL, Elkassas N, Zakaria D. Cancers (Basel). In a Jan. 17, 2020, establishment inspection report obtained by KHN, one of three FDA experts who visited wrote that Pfizer said it addressed problems and added more cleaning activities in response to mold after a 2018 inspection and yet, there are still unexplained discrepancies.. AGIHO guideline on evidence-based management of COVID-19 in cancer patients: 2022 update on vaccination, pharmacological prophylaxis and therapy in light of the omicron variants. Jeff Kowalsky/AFP/Getty Images. Radiation recall: A well-recognized but neglected phenomenon. He stated all improvements related to covid manufacturing would be completed before vaccine production begins. WEDNESDAY, March 1, 2023 (HealthDay News) -- In a tight vote, U.S. Food and Drug Administration advisers on Tuesday recommended the approval of a respiratory syncytial virus (RSV . When the FDA came back to inspect in late summer 2018, it found that procedures to prevent microbiological contamination of drugs were lacking. Cancer Patients and the COVID-19 Vaccines: Considerations and Challenges. Pfizer's jab tells the body to create the coronavirus's unique spike protein, training the immune system to recognise and fight off future infection. Pfizer and Moderna have refused to reveal whatpercentage mRNA integrity they consider acceptable for vaccines against Covid. Huge jail is already over capacity, packed with 'Why the last-minute delay?' In 2020, the pharmaceutical company Gilead Sciences signed a multiyear agreement with Pfizer to produce its covid treatment remdesivir in the Kansas plant. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). A Pfizer spokesperson told MailOnline the quality issues were ironed out with the EMA and none of the vaccines of concern were rolled out on the continent. Last week, Pfizer and partner BioNTech BNTX applied to the FDA for Emergency Use Authorization (EUA) for an additional or "fourth" booster dose of their COVID-19 vaccine for adults 65 years of . Additionally, single-cell RNA sequencing showed a reduction in IgA+ memory B cells following vaccination, a finding that has recently been described for convalescent individuals. At the end of the January 2020 inspection, FDA investigators appeared to be growing frustrated. No other systemic grade 4 reactions were reported. The interval recommendations for Johnson & Johnson (two months) and . The site is secure. So, what's the point? 1 . Trivanovi D, Peruri , Agaj A, Jakopovi M, Samarija M, Bitar L, Paveli K. Int J Mol Sci. -, Garza L.A., Yoo E.K., Junkins-Hopkins J.M., et al. December 8, 2022), An official website of the United States government, : A single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine in individuals 5 years of age and older. Share. Epub 2021 Dec 6. Owned and operated by AZoNetwork, 2000-2023. Coronavirus Disease 2019 (COVID-19), Recalls, Market Withdrawals and Safety Alerts, COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders, Informacin sobre las vacunas para el COVID-19, FAQ for Comirnaty (COVID-19 Vaccine mRNA), Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine, HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA CONTRA EL COVID-19 DE PFIZER-BIONTECH PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN NIOS DE 6 MESES A 4 AOS, 6 4 2019 (COVID-19) COVID-19 , 6 4 2019 (COVID-19) - COVID-19 , FACT SHEET PARA SA MGA TATANGGAP AT MGA NAG-AALAGA TUNGKOL SA BAKUNANG PFIZER-BIONTECH COVID-19 UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) PARA SA PAGGAMIT SA MGA INDIBIDWAL 6 NA BUWAN HANGGANG 4 NA TAONG GULANG, PHIU THC T DNH CHO NGI NHN V NGI CHM SC V THUC CHA BNH PFIZER-BIONTECH COVID-19 PHNG NGA BNH HI LO HA 2019 (COVID-19) S DNG CHO C NHN 6 THNG QUA 4 TUI, HOJA INFORMATIVA DE VACUNAS PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN PERSONAS DE 5 A 11 AOS, 2019COVID-192019 511, 5 11 2019 (COVID-19) (PFIZER)- (BIONTECH) -19 , BAKUNA IMPORMASYON FACT SHEET PARA SA MGA TUMANGGAP AT MGA TAGAPAG-ALAGA TUNGKOL SA PFIZER-BIONTECH COVID-19 BAKUNA UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) PARA SA PAGGAMIT SA MGA INDIBIDWAL 5 HANGGANG 11 TAONG GULANG, BNG THNG TIN V VC XIN DNH CHO NGI NHN V NGI CHM SC V VC XIN PFIZER-BIONTECH COVID-19 NHM PHNG NGA BNH CORONAVIRUS 2019 (COVID-19) S DNG CHO C NHN T 5 TI 11 TUI, HOJA INFORMATIVA DE VACUNAS PARA RECEPTORES Y CUIDADORES SOBRE COMIRNATY (VACUNA DE ARNm CONTRA EL COVID-19) Y LA VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN PERSONAS DE 12 AOS O MS, (2019)-BioNTech20192019, 2019 (COVID-19) (-19 , RNA) (PFIZER)- (BIONTECH) -19 , FACT SHEET NG IMPORMASYON SA BAKUNA PARA SA MGA TANGGAP AT CAREGIVERS TUNGKOL SA COMIRNATY (COVID-19 VACCINE, mRNA)AT BAKUNA NA PFIZER-BIONTECH COVID-19 UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19), T D KIN THNG TIN V VC XIN DNH CHO NGI NHN V NGI CHM SC V COMIRNATY (VC XIN COVID-19, mRNA)V VC XIN PFIZER-BIONTECH COVID-19 PHNG NGA BNH CORONAVIRUS 2019 (COVID-19), 6 months through 4 years, maroon cap (must dilute), 5 years through 11 years of age, orange cap (must dilute), 12 years of age and older, purple cap (must dilute), 12 years of age and older, gray cap (no dilution), Change in Third Dose of 3-Dose Primary Series. Vaccine Adverse Event Reporting System (VAERS), How Vaccines are Tested, Licensed, and Monitored for Safety, FDAs Recalls, Withdrawals, Field Corrections, & Notifications, Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), Diphtheria, Tetanus, and Pertussis Vaccines, Measles, Mumps, Rubella, Varicella (MMRV) Vaccines, CDC Statement: 2004 Pediatrics Paper on MMR and Autism, CDC Study (2010 ) on Thimerosal and Risk of Autism, Infant and Environmental Exposures to Thimerosal 2007 Study, Narcolepsy Following Pandemrix Influenza Vaccination in Europe, CISA Resources for Healthcare Professionals, Accessing Data from Vaccine Safety Datalink, Frequently Asked Questions and Troubleshooting, U.S. Department of Health & Human Services. He said he fears the fixes have been little but window dressing., They may have solved it in one instance, like the cardboard particles. CDC twenty four seven. We distribute our journalism for free and without advertising through media partners of all sizes and in communities large and small. Your audience is not a meeting of the virology symposium of America. It also noted a lack of employee training, employees not following procedures, obstructed surfaces and in-house testing that did not guarantee drugs met standards. The facilitys record of recalls and field alerts include vials of medication that contained glass and cardboard particles and, as one customer complained, a small insect or speck of dust., A 2017 FDA warning letter which is a strong rebuke for the agency said the contaminants such as cardboard and glass found in vials posed a severe risk of harm to patients and indicated that the facilitys process for manufacturing sterile injectable products was out of control.. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Before Pfizers plant managers told investigators they knew they had either bacteria or mold throughout the facility at various times of the year. SARS-CoV-2 Infection and Vaccination Cutaneous Manifestations for the Inpatient Dermatologist. That latest inspection spanned three weeks from December 2019 to January 2020 and inspectors wrote management was cooperative and no refusals were encountered., Christopher Smith, vice president of quality operations for Pfizers U.S. and European Union sterile injectables, was at the McPherson facility periodically during the visit. "Pfizer-BioNTech and Moderna COVID-19 vaccines establish recall responses to reinfection". Information on recalled lots of is available by year from FDAexternal icon. After the January 2020 inspection report, Pfizer immediately developed and put in place a corrective action plan, company spokesperson Eamonn Nolan told KHN. See this image and copyright information in PMC. In 2020, the pharmaceutical company Gilead Sciences signed a multiyear agreement with Pfizer to produce its covid treatment remdesivir in the Kansas plant. How Matt Hancock and Priti Patel shared stories of heavy-handed police ANDREW NEIL: What's REALLY going on in Boris Johnson's head - and why I'd advise Rishi Sunak to sleep with JANET STREET-PORTER: You're not a teenager, Mr Hancock. Heres what we ask: You must credit us as the original publisher, with a hyperlink to our khn.org site. with these terms and conditions. In these cases, the safety of these vaccines was monitored continuously before and after they were in use. Part of the Daily Mail, The Mail on Sunday & Metro Media Group. The process of developing mRNA vaccines is also purely synthetic, meaning scientists don't have to rely on cells from living animals. The EMA, US Food and Drug Administration (FDA) stated that specific information on criteria is confidential. Does COVID-19 accelerate the worsening of clinical disabilities in multiple sclerosis patients? Himed S, Gray A, Awethe Z, Libson K, Kaffenberger BH, Korman AM, Trinidad JCL. . The documents were leaked to the British Medical Journal (BMJ) following a cyber attack on the EU regulator in December. The FDA rejected Pfizers biosimilar version of Amgens anemia drug Epogen because of concerns about the fill/finish plant in 2017. Potentiation of x-ray effects by actinomycin. Nearly a decades worth of FDA inspection reports, recalls and reprimands reviewed by KHN show the facility as a repeat offender. The .gov means its official.Federal government websites often end in .gov or .mil. 8600 Rockville Pike CDC recommends everyone stay up to date with COVID-19 vaccines for their age group: Children and teens aged 6 months-17 years. The EMA found just 55 per cent of the mRNA in the vaccines shipped to the EU were stable and intact, compared to 78 per cent in Pfizer's studies. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older. In the end, he expressed discontent with several of the 2020 observations made by investigators and repeatedly sought clarifications., Sarah Jane Tribble: 2021 Nov 1;111(3):835-836. doi: 10.1016/j.ijrobp.2021.06.023. FDA vaccine advisers have recommended the nation's first RSV vaccine from Pfizer. 10 min read. The company announced a nationwide recall Monday and said it was pulling six lots of its Accuretic tablets. 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MMWR Morb Mortal Wkly Rep. 2021 Jan 15;70(2):46-51. doi: 10.15585/mmwr.mm7002e1. Please note that medical information found Vaccine efficacy/effectiveness is interpreted as the proportionate reduction in disease among the vaccinated group. (b) Acute skin reaction after COVID-19 vaccination (Patient 2). Get a COVID-19 vaccine and you'll be counseled to keep wearing a mask and keep staying away from other people. You will be subject to the destination website's privacy policy when you follow the link. KHN is an editorially independent program of KFF (Kaiser Family Foundation). Side Effects. (December 8, 2022), 2019COVID-192019 511 (December 8, 2022), 5 11 2019 (COVID-19) (PFIZER)- (BIONTECH) -19 Compilation of the top interviews, articles, and news in the last year. The site along Middletown Road is also where the Pfizer-BioNTech COVID vaccine came to fruition. Pfizer and BioNTech on Friday said they were delaying their request for the Food and Drug Administration to authorize their Covid-19 . (December 8, 2022), 6 4 2019 (COVID-19) - COVID-19 00:00. BRILLIANT!' Clipboard, Search History, and several other advanced features are temporarily unavailable. Stuart ASV, Shaw RH, Liu X, Greenland M, Aley PK, Andrews NJ, Cameron JC, Charlton S, Clutterbuck EA, Collins AM, Darton T, Dinesh T, Duncan CJA, England A, Faust SN, Ferreira DM, Finn A, Goodman AL, Green CA, Hallis B, Heath PT, Hill H, Horsington BM, Lambe T, Lazarus R, Libri V, Lillie PJ, Mujadidi YF, Payne R, Plested EL, Provstgaard-Morys S, Ramasamy MN, Ramsay M, Read RC, Robinson H, Screaton GR, Singh N, Turner DPJ, Turner PJ, Vichos I, White R, Nguyen-Van-Tam JS, Snape MD; Com-COV2 Study Group. hodge road shooting area 2020,