Dr. Emily Erbelding, Director of NIH Infectious Disease, in response to Dr. Joseph Lee

responding to my letter to Dr. Anthony Fauci, explaining the fatal flaw with the COVID vaccine

Erbelding, Emily (NIH/NIAID) [E] <emily.erbelding@nih.gov>

To:joeleemd XXXXXX

Wed, Oct 28, 2020 at 8:2@yahoo.com0 AM

Dear Dr. Lee:

Thank you for your recent email directed to Dr. Francis Collins, Director of the National Institutes of Health (NIH); Dr. Lawrence Tabak, Principal Deputy Director of the NIH; Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), NIH; Dr. Gary Gibbons, Director of the National Heart, Lung, and Blood Institute, NIH; and Dr. Amy Wernimont in the NIH Center for Scientific Review regarding vaccine-induced immune responses to respiratory infections, particularly severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19).  Your message was forwarded to NIAID for response.  NIAID is the NIH Institute with primary responsibility for research on infectious, immunologic, and allergic diseases.  As the Director of the NIAID Division of Microbiology and Infectious Diseases, I am pleased to respond.

Patients infected with SARS-CoV-2 may present with a range of symptoms of varying severity, from fever and shortness of breath to pneumonia and acute respiratory distress syndrome.  Symptom presentation is indicative of the region of the lungs infected by SARS-CoV-2, with infection of the lower respiratory tract causing moderate to severe disease outcomes.

Preclinical animal studies of SARS-CoV-2 candidate vaccines have evaluated viral titers and the level of neutralizing antibodies in bronchoalveolar lavage (BAL) fluid collected from the lower respiratory tract.  Investigators found evidence of reduced viral replication and an increase in antibodies to the antigen in the candidate vaccine in BAL fluid [1, 2, 3, 4] (antibodies from blood plasma cross the blood-air interface and enter the BAL fluid through a process called transudation; secretion from the airway tissues and the immune response localized in the lung also play a role [5]).  Further, preclinical animal studies have also shown that SARS-CoV-2 candidate vaccines control SARS-CoV-2 infection in the airways as well as prevent pneumonia [1, 2, 3, 4].

Building on the preclinical animal studies, evaluation of SARS-CoV-2 candidate vaccines in Phase 1 and 2 clinical trials have shown that the candidate vaccines induce neutralizing antibody responses and cell mediated responses (T cell responses); further analysis of these immune responses is ongoing [6, 7, 8, 9, 10, 11].  The induction of antibody and cell mediated responses is indicative of a multifaceted immune response, which is important in protecting against disease.  Currently, several SARS-CoV-2 candidate vaccines are being evaluated in large Phase 3 clinical trials to determine the effectiveness of a candidate vaccine in protecting against symptomatic COVID-19 disease.  The results of these trials will determine whether one or more SARS-CoV-2 vaccines may be administered at the population level.  Guidance from the U.S. Food and Drug Administration has indicated that prevention of severe disease due to SARS-CoV-2 will be one standard for vaccine approval, along with safety considerations (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19). 

In addition, monoclonal antibodies have also been shown to reduce COVID-19 disease and enhance recovery.   Data from pre-clinical, as well as clinical trials, have demonstrated anti-viral effects of these neutralizing antibodies directed at the spike protein with important clinical benefits [12, 13, 14, 15].  This is precisely the type of immune response the vaccines are designed to elicit.

Further, the effectiveness of immunizations against influenza, Bordetella pertussis, Streptococcus pneumoniae, Haemophilus influenzae type b, measles, and tuberculosis, demonstrates the utility of vaccines in combating respiratory infections.  Moreover, monoclonal antibodies against respiratory syncytial virus are used to prevent serious disease in the lower respiratory tract of recipients.

We appreciate the opportunity to describe the results of some studies regarding the development of vaccines and monoclonal antibodies to combat COVID-19, and hope you find this information useful.

                                                                                   Sincerely,

                                                                                   Emily Erbelding, M.D., M.P.H.

                                                                                   Director

                                                                                   Division of Microbiology and Infectious Diseases